BMS-Reyataz Study in Treatment in Naive Subjects to Compare the Efficacy and Safety Between Boosted Reyataz and Kaletra When in Combination With Fixed Dose Truvada

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00272779
First received: January 5, 2006
Last updated: April 7, 2011
Last verified: April 2011
Results First Received: December 3, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: ATV
Drug: RTV
Drug: Tenofovi-Emtricitabine (TDF/FTC) tablet
Drug: LPV

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of 1057 HIV-infected participants, 174 participants were not randomized to receive study drug, the main reason being that they did not meet the study criteria (133/174; 76%). 441 randomized to ATV received any drug and 437 randomized to LPV received any drug. 438 and 440 participants randomized to ATV and LPV, respectively, received correct drug.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Participant Flow for 2 periods

Period 1:   Baseline Through Week 48
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
STARTED     440 [1]   443 [2]
RECEIVED ANY TREATMENT     441 [3]   437 [4]
TREATED AS RANDOMIZED     438     440  
Discontinued Before Week 48     39     58  
Discontinued on or After Week 48     14     14  
STILL ON TREATMENT     385     368  
COMPLETED     0     0  
NOT COMPLETED     440     443  
Adverse event before Week 48                 10                 14  
Death before Week 48                 4                 4  
Lack of efficacy before Week 48                 5                 8  
Lost to follow-up before Week 48                 6                 6  
Viral load rebound before Week 48                 1                 0  
Poor/non compliance before Week 48                 6                 9  
Pregnancy before Week 48                 2                 2  
No longer meets criteria before Week 48                 1                 0  
Withdrew consent before Week 48                 4                 13  
Participant's decision before wk 48                 0                 1  
Chose different site before wk 48                 0                 1  
Adverse event on/after Week 48                 1                 1  
Death on/after Week 48                 1                 1  
Lack of efficacy on/after Week 48                 7                 1  
Poor/non compliance on/after Week                 2                 2  
No longer meets criteria on/after Wk 48                 2                 2  
Pregnancy on/after Week 48                 1                 2  
Withdrew consent on/after Week 48                 0                 2  
Continuing treatment                 385                 368  
Lost to follow-up on/after Week 48                 0                 3  
Never treated                 2                 3  
[1] Number of participants randomized to ATV
[2] Number of participants randomized to LPV
[3] 1 participant randomized to LPV received ATV instead (treatment error)
[4] 3 participants received ATV instead of LPV (treatment error), 3 participants never treated with LPV

Period 2:   Baseline Through Week 96
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
STARTED     440 [1]   443 [2]
RECEIVED ANY TREATMENT     441 [3]   437 [4]
COMPLETED     301     307  
NOT COMPLETED     139     136  
Adverse event before Week 96                 13                 22  
Death before Week 96                 6                 5  
Lack of efficacy before Week 96                 16                 10  
Lost to follow up before Week 96                 10                 13  
Participant Imprisoned before Week 96                 1                 0  
Poor/non compliance before Week 96                 12                 16  
Pregnancy before Week 96                 5                 7  
No longer meets criteria before Week 96                 4                 3  
Withdrew consent before Week 96                 5                 18  
Changed address before Week 96                 0                 1  
Lost to follow-up at Week 96                 1                 0  
Poor/non compliance at Week 96]                 2                 0  
Pregnancy at Week 96                 1                 0  
Never treated                 2                 3  
Continuing on treatment                 61                 38  
[1] Number randomized to ATV
[2] Number randomized to LPV
[3] 1 participant randomized to LPV received ATV instead (treatment error)
[4] 3 participants received ATV instead of LPV (treatment error) and 3 participants never treated



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
Total Total of all reporting groups

Baseline Measures
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD     Total  
Number of Participants  
[units: participants]
  440     443     883  
Age  
[units: years]
Mean ± Standard Deviation
  36  ± 9.1     37  ± 10.0     36  ± 9.6  
Gender  
[units: participants]
     
Female     138     139     277  
Male     302     304     606  
Race/Ethnicity, Customized  
[units: participants]
     
Asian     42     41     83  
Black or African American     83     80     163  
White     207     221     428  
Hispanic/Latino     7     6     13  
Mestizo     71     68     139  
Mixed race     30     27     57  



  Outcome Measures
  Hide All Outcome Measures

1.  Primary:   Number of Participants With Human-immunodeficiency Virus- Ribonucleic Acid (HIV-RNA) < 50 Copies (c)/mL at Week 48   [ Time Frame: Baseline (Day 1) and Week 48 ]

Measure Type Primary
Measure Title Number of Participants With Human-immunodeficiency Virus- Ribonucleic Acid (HIV-RNA) < 50 Copies (c)/mL at Week 48
Measure Description HIV RNA < 50 c/mL is the most stringent measure of viral suppression (lowest threshold of assay) and indicates that a participant responded to treatment.
Time Frame Baseline (Day 1) and Week 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-treat (ITT) analysis. Participants received treatment assignment from the central randomization center. In this analysis, participants who did not complete the study were counted as having failed to respond to treatment. Participants who discontinued prior to obtaining Week 48 HIV RNA levels were categorized under non-completers.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  440     443  
Number of Participants With Human-immunodeficiency Virus- Ribonucleic Acid (HIV-RNA) < 50 Copies (c)/mL at Week 48  
[units: Participants]
  343     338  


Statistical Analysis 1 for Number of Participants With Human-immunodeficiency Virus- Ribonucleic Acid (HIV-RNA) < 50 Copies (c)/mL at Week 48
Groups [1] All groups
Method [2] Cochran-Mantel-Haenszel
Difference Estimate [3] 1.7
95% Confidence Interval ( -3.8 to 7.1 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Treatment regimens compared by calculation of the difference in proportions (atazanavir/ritonavir– lopinavir/ritonavir) and 95% CI based on stratified normal approximation.Analyses were stratified by the same strata as randomization—HIV RNA level at enrollment and geographic region.The proportion of participants with HIV RNA below 50 copies/mL was computed within each stratum, and combined by use of a weighted average with weights proportional to stratum size:Cochran-Mantel-Haenszel weighting
[2] Other relevant method information, such as adjustments or degrees of freedom:
  The ATV/RTV regimen was deemed to be non-inferior to the lopinavir/ritonavir regimen if the lower CI for the difference in proportions > –10%.
[3] Other relevant estimation information:
  No text entered.



2.  Primary:   Maximum Plasma Concentration (Cmax) of ATV/RTV and LPV/RTV in the Presence of an Antiretroviral (ARV) Regimen Including TDF at Week 4   [ Time Frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given every day (QD) and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given twice daily (BID) and TDF given QD. ]

Measure Type Primary
Measure Title Maximum Plasma Concentration (Cmax) of ATV/RTV and LPV/RTV in the Presence of an Antiretroviral (ARV) Regimen Including TDF at Week 4
Measure Description Cmax was derived from plasma concentration versus time data.
Time Frame Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given every day (QD) and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given twice daily (BID) and TDF given QD.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who completed the intensive pharmacokinetic (PK) study.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  18     21  
Maximum Plasma Concentration (Cmax) of ATV/RTV and LPV/RTV in the Presence of an Antiretroviral (ARV) Regimen Including TDF at Week 4  
[units: nanogram(ng)/mL]
Geometric Mean ( Full Range )
  2897  
  ( 837.0 to 5610 )  
  10654  
  ( 5658 to 31316 )  

No statistical analysis provided for Maximum Plasma Concentration (Cmax) of ATV/RTV and LPV/RTV in the Presence of an Antiretroviral (ARV) Regimen Including TDF at Week 4



3.  Primary:   Area Under the Concentration-time Curve, in One Dosing Interval [AUC(TAU)] of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4   [ Time Frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD. ]

Measure Type Primary
Measure Title Area Under the Concentration-time Curve, in One Dosing Interval [AUC(TAU)] of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4
Measure Description AUC(TAU) was derived from the plasma concentration versus time data. It was calculated from time 0 to 12 hours for LPV and RTV in the LPV/RTV regimen, 0-24 hours for ATV and RTV in the ATV/RTV regimen, and 0-24 hours for tenofovir in both regimens at Week 4.
Time Frame Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who completed the intensive PK study.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  18     21  
Area Under the Concentration-time Curve, in One Dosing Interval [AUC(TAU)] of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4  
[units: ng*h/mL]
Geometric Mean ( Full Range )
  28605  
  ( 9908 to 58872 )  
  90945  
  ( 43260 to 302989 )  

No statistical analysis provided for Area Under the Concentration-time Curve, in One Dosing Interval [AUC(TAU)] of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4



4.  Primary:   Minimum Plasma Concentration (Cmin) of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4   [ Time Frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD. ]

Measure Type Primary
Measure Title Minimum Plasma Concentration (Cmin) of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4
Measure Description Cmin was derived from the plasma concentration versus time data.
Time Frame Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who completed the intensive PK study.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  18     21  
Minimum Plasma Concentration (Cmin) of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4  
[units: ng/mL]
Geometric Mean ( Full Range )
  526.4  
  ( 130.0 to 1350 )  
  5944  
  ( 1555 to 22739 )  

No statistical analysis provided for Minimum Plasma Concentration (Cmin) of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4



5.  Primary:   Time to Reach Maximum Observed Plasma Concentration (Tmax) of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4   [ Time Frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD. ]

Measure Type Primary
Measure Title Time to Reach Maximum Observed Plasma Concentration (Tmax) of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4
Measure Description Tmax was derived from the plasma concentration versus time data.
Time Frame Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who completed the intensive PK study.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  18     21  
Time to Reach Maximum Observed Plasma Concentration (Tmax) of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4  
[units: Hr]
Median ( Full Range )
  3.00  
  ( 1.50 to 24.00 )  
  4.00  
  ( 0.00 to 12.00 )  

No statistical analysis provided for Time to Reach Maximum Observed Plasma Concentration (Tmax) of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4



6.  Primary:   Terminal Elimination Half-life (T-half) of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4   [ Time Frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD. ]

Measure Type Primary
Measure Title Terminal Elimination Half-life (T-half) of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4
Measure Description T-half was derived from the plasma concentration versus time data.
Time Frame Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who completed the intensive PK study.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  17     12  
Terminal Elimination Half-life (T-half) of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4  
[units: Hr]
Mean ± Standard Deviation
  10.31  ± 3.32     13.89  ± 14.48  

No statistical analysis provided for Terminal Elimination Half-life (T-half) of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4



7.  Primary:   Protein Binding Adjusted Effective Concentration (EC-90) of ATV and LPV When Dosed With RTV at Week 4   [ Time Frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD. ]

Measure Type Primary
Measure Title Protein Binding Adjusted Effective Concentration (EC-90) of ATV and LPV When Dosed With RTV at Week 4
Measure Description EC90/50=concentration of drug inducing 90%/50% of its maximal response. Protein binding adjusted EC90 for ATV and LPV were derived from phenotypically measured individual EC50 values at baseline using the following formula: Protein binding adjusted EC90 (ng/mL) = scale factor × molecular weight of the free base × EC50 micrometer(μM)/ unbound fraction (fu). Scale factor relates EC50 to EC90 (value of 3 and 2 for ATV and LPV, respectively); fu: estimated unbound fraction of ATV and LPV in vivo (0.14 and 0.02 for ATV and LPV respectively).
Time Frame Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who completed the intensive PK study.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  17     19  
Protein Binding Adjusted Effective Concentration (EC-90) of ATV and LPV When Dosed With RTV at Week 4  
[units: ng/mL]
Geometric Mean ( Full Range )
  19.01  
  ( 8.29 to 35.23 )  
  162.7  
  ( 100.6 to 471.6 )  

No statistical analysis provided for Protein Binding Adjusted Effective Concentration (EC-90) of ATV and LPV When Dosed With RTV at Week 4



8.  Primary:   Inhibitory Quotient (IQ) of ATV and LPV When Dosed With RTV at Week 4   [ Time Frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD. ]

Measure Type Primary
Measure Title Inhibitory Quotient (IQ) of ATV and LPV When Dosed With RTV at Week 4
Measure Description IQ defined as Cmin at week 4 divided by protein binding adjusted EC90 values for the respective protease inhibitor (ATV or LPV) derived from individual participant clinical isolates.
Time Frame Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who completed the intensive PK study.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  17     19  
Inhibitory Quotient (IQ) of ATV and LPV When Dosed With RTV at Week 4  
[units: ng/mL]
Geometric Mean ( Full Range )
  27.33  
  ( 3.94 to 77.27 )  
  35.91  
  ( 10.76 to 129.0 )  


Statistical Analysis 1 for Inhibitory Quotient (IQ) of ATV and LPV When Dosed With RTV at Week 4
Groups [1] All groups
Method [2] ANOVA
point estimate [3] 0.761
90% Confidence Interval ( 0.507 to 1.142 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  Point estimates and 90% confidence intervals (CIs) for differences between treatment regimens were calculated on the log scale, and were exponentiated to obtain estimates for ratios of geometric means on the original scale.



9.  Primary:   Cmax of RTV at Week 4   [ Time Frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD. ]

Measure Type Primary
Measure Title Cmax of RTV at Week 4
Measure Description Cmax was derived from plasma concentration versus time data.
Time Frame Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who completed the intensive PK study.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  18     21  
Cmax of RTV at Week 4  
[units: ng/mL]
Geometric Mean ( Full Range )
  959.8  
  ( 139.0 to 2900 )  
  657.4  
  ( 193.8 to 1814 )  


Statistical Analysis 1 for Cmax of RTV at Week 4
Groups [1] All groups
Method [2] ANOVA
point estimate [3] 1.460
90% Confidence Interval ( 1.005 to 2.121 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  Point estimates and 90% CIs for differences between treatment regimens were calculated on the log scale, and were exponentiated to obtain estimates for ratios of geometric means on the original scale.



10.  Primary:   AUC (0-24) of RTV at Week 4   [ Time Frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD. ]

Measure Type Primary
Measure Title AUC (0-24) of RTV at Week 4
Measure Description AUC (0-24) was derived from plasma concentration versus time data. It was estimated as 2 times the AUC(TAU) based on 12-hour PK.
Time Frame Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who completed the intensive PK study.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  18     21  
AUC (0-24) of RTV at Week 4  
[units: ng*h/mL]
Geometric Mean ( Full Range )
  6724  
  ( 1371 to 23854 )  
  8011  
  ( 2815 to 19929 )  


Statistical Analysis 1 for AUC (0-24) of RTV at Week 4
Groups [1] All groups
Method [2] ANOVA
point estimate [3] 0.839
90% Confidence Interval ( 0.612 to 1.151 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  Point estimates and 90% CIs for differences between treatment regimens were calculated on the log scale, and were exponentiated to obtain estimates for ratios of geometric means on the original scale.



11.  Primary:   Cmin of RTV at Week 4   [ Time Frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD. ]

Measure Type Primary
Measure Title Cmin of RTV at Week 4
Measure Description Cmin was derived from plasma concentration versus time data.
Time Frame Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who completed the intensive PK study.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  18     21  
Cmin of RTV at Week 4  
[units: ng/mL]
Geometric Mean ( Full Range )
  50.52  
  ( 14.50 to 298.0 )  
  179.0  
  ( 42.82 to 763.8 )  


Statistical Analysis 1 for Cmin of RTV at Week 4
Groups [1] All groups
Method [2] ANOVA
point estimate [3] 0.282
90% Confidence Interval ( 0.181 to 0.439 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  Point estimates and 90% CIs for differences between treatment regimens were calculated on the log scale, and were exponentiated to obtain estimates for ratios of geometric means on the original scale.



12.  Primary:   Cmax of Tenofovir at Week 4   [ Time Frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD. ]

Measure Type Primary
Measure Title Cmax of Tenofovir at Week 4
Measure Description Cmax was derived from plasma concentration versus time data.
Time Frame Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who completed the intensive PK study.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  17     20  
Cmax of Tenofovir at Week 4  
[units: ng/mL]
Geometric Mean ( Full Range )
  352.0  
  ( 104.8 to 641.8 )  
  380.7  
  ( 118.0 to 1801 )  


Statistical Analysis 1 for Cmax of Tenofovir at Week 4
Groups [1] All groups
Method [2] ANOVA
point estimate [3] 0.925
90% Confidence Interval ( 0.699 to 1.223 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  Point estimates and 90% CIs for differences between treatment regimens were calculated on the log scale, and were exponentiated to obtain estimates for ratios of geometric means on the original scale.



13.  Primary:   Cmin of Tenofovir at Week 4   [ Time Frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD. ]

Measure Type Primary
Measure Title Cmin of Tenofovir at Week 4
Measure Description Cmin was derived from plasma concentration versus time data.
Time Frame Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who completed the intensive PK study.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  17     20  
Cmin of Tenofovir at Week 4  
[units: ng/mL]
Geometric Mean ( Full Range )
  72.46  
  ( 21.08 to 114.7 )  
  84.98  
  ( 44.27 to 757.2 )  


Statistical Analysis 1 for Cmin of Tenofovir at Week 4
Groups [1] All groups
Method [2] ANOVA
point estimate [3] 0.853
90% Confidence Interval ( 0.626 to 1.161 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  Point estimates and 90% CIs for differences between treatment regimens were calculated on the log scale, and were exponentiated to obtain estimates for ratios of geometric means on the original scale.



14.  Primary:   AUC (TAU) of Tenofovir at Week 4   [ Time Frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD. ]

Measure Type Primary
Measure Title AUC (TAU) of Tenofovir at Week 4
Measure Description AUC (TAU) was derived from plasma concentration versus time data.It was calculated from time 0-24 hours for tenofovir in LPV/RPV and ATV/RTV regimen at Week 4.
Time Frame Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who completed the intensive PK study.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  17     20  
AUC (TAU) of Tenofovir at Week 4  
[units: ng*h/mL]
Geometric Mean ( Full Range )
  3272  
  ( 1678 to 5486 )  
  3675  
  ( 2240 to 25385 )  


Statistical Analysis 1 for AUC (TAU) of Tenofovir at Week 4
Groups [1] All groups
Method [2] ANOVA
point estimate [3] 0.890
90% Confidence Interval ( 0.689 to 1.151 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  Point estimates and 90% CIs for differences between treatment regimens were calculated on the log scale, and were exponentiated to obtain estimates for ratios of geometric means on the original scale.



15.  Primary:   Mean Change From Baseline in Trunk-to-Limb Fat Ratio as Measured by Dual Energy X-ray Absorptiometry (DEXA) at Week 96   [ Time Frame: Baseline (Day 1) and Week 96. ]

Measure Type Primary
Measure Title Mean Change From Baseline in Trunk-to-Limb Fat Ratio as Measured by Dual Energy X-ray Absorptiometry (DEXA) at Week 96
Measure Description Mean changes from baseline in trunk-to-limb fat ratio as measured by DEXA, an x-ray scan used to measure bone mineral density. Clinical improvement is associated with a decrease in values.
Time Frame Baseline (Day 1) and Week 96.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  106     70  
Mean Change From Baseline in Trunk-to-Limb Fat Ratio as Measured by Dual Energy X-ray Absorptiometry (DEXA) at Week 96  
[units: Ratio]
Mean ± Standard Error
  0.05  ± 0.015     0.00  ± 0.015  

No statistical analysis provided for Mean Change From Baseline in Trunk-to-Limb Fat Ratio as Measured by Dual Energy X-ray Absorptiometry (DEXA) at Week 96



16.  Primary:   Number of Participants With Single Nucleotide Polymorphisms (SNPs) Included in Genotype-Phenotype Analysis   [ Time Frame: Baseline visit ]

Measure Type Primary
Measure Title Number of Participants With Single Nucleotide Polymorphisms (SNPs) Included in Genotype-Phenotype Analysis
Measure Description 19 genes of interest were selected from previous results or literature, and 34 SNPs were genotyped. Phenotype-Genotype analysis was performed using 31 of the SNPs. The genotypes of each SNP were further classified as either a minor allele carrier (MAC) group composed of heterozygous and rare homozygous genotypes, or wild type [WT, common homozygous].
Time Frame Baseline visit  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. The Hardy-Weinberg Equilibrium test was used to check for the genotype quality. All SNPs passed the quality check.

Reporting Groups
  Description
All Participants With Pharmacogenetic Blood Samples Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.

Measured Values
    All Participants With Pharmacogenetic Blood Samples  
Number of Participants Analyzed  
[units: participants]
  199  
Number of Participants With Single Nucleotide Polymorphisms (SNPs) Included in Genotype-Phenotype Analysis  
[units: participants]
 
RETN_097 WT     164  
RETN_097 MAC     35  
APOE_R176C WT     182  
APOE_R176C MAC     16  
CCDC122_5980 WT     126  
CCDC122_5980 MAC     71  
IL6_5309 WT     57  
IL6_5309 MAC     141  
RS11030679 WT     112  
RS11030679 MAC     87  
APOE_C130R WT     169  
APOE_C130R MAC     30  
RETN_2265 WT     146  
RETN_2265 MAC     53  
RETN_598 WT     119  
RETN_598 MAC     80  
RETN_734 WT     175  
RETN_734 MAC     22  
BRUNOL_1842 WT     121  
BRUNOL_1842 MAC     77  
RETN_730 WT     99  
RETN_730 MAC     100  

No statistical analysis provided for Number of Participants With Single Nucleotide Polymorphisms (SNPs) Included in Genotype-Phenotype Analysis



17.  Primary:   Mean Change From Baseline in Fasting Non-High Density Lipoprotein (HDL) Cholesterol Associated With RETN_097   [ Time Frame: Baseline (Day 1), Week 48, and Week 96. ]

Measure Type Primary
Measure Title Mean Change From Baseline in Fasting Non-High Density Lipoprotein (HDL) Cholesterol Associated With RETN_097
Measure Description The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted (adj) p-values were calculated for each phenotype-genotype pair.
Time Frame Baseline (Day 1), Week 48, and Week 96.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  99     100  
Mean Change From Baseline in Fasting Non-High Density Lipoprotein (HDL) Cholesterol Associated With RETN_097  
[units: mg/dL]
Mean ± Standard Error
   
Fasting Non-HDL Cholesterol: RETN_097 WT     12.50  ± 2.82     26.98  ± 2.96  
Fasting Non-HDL Cholesterol: RETN_097 MAC     13.23  ± 5.56     52.28  ± 6.67  


Statistical Analysis 1 for Mean Change From Baseline in Fasting Non-High Density Lipoprotein (HDL) Cholesterol Associated With RETN_097
Groups [1] All groups
Method [2] linear mixed effect model
P Value [3] 0.0847
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Null Hypothesis: There is no association between the mean change from baseline in fasting non-HDL cholesterol (phenotype) and the RETN_097 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, week 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with RETN_097 reported in Outcome Measure 16.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values <0.2 reported)
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.



18.  Primary:   Mean Change From Baseline in Fasting Triglycerides Associated With RETN_097   [ Time Frame: Baseline (Day 1), Week 48, and Week 96. ]

Measure Type Primary
Measure Title Mean Change From Baseline in Fasting Triglycerides Associated With RETN_097
Measure Description The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair.
Time Frame Baseline (Day 1), Week 48, and Week 96.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  99     100  
Mean Change From Baseline in Fasting Triglycerides Associated With RETN_097  
[units: mg/dL]
Mean ± Standard Error
   
Fasting Triglycerides: RETN_097 WT     21.41  ± 8.6     68.06  ± 9.01  
Fasting Triglycerides: RETN_097 MAC     27.21  ± 16.9     157.87  ± 20.4  


Statistical Analysis 1 for Mean Change From Baseline in Fasting Triglycerides Associated With RETN_097
Groups [1] All groups
Method [2] linear mixed effect model
P Value [3] 0.0058
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Null Hypothesis: There is no association between the mean change from baseline in fasting triglycerides (phenotype) and the RETN_097 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, week 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with RETN_097 reported in Outcome Measure 16.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values <0.2 reported)
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.



19.  Primary:   Mean Change From Baseline in Fasting Triglycerides Associated With RETN_2265   [ Time Frame: Baseline (Day 1), Week 48, and Week 96. ]

Measure Type Primary
Measure Title Mean Change From Baseline in Fasting Triglycerides Associated With RETN_2265
Measure Description The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair.
Time Frame Baseline (Day 1), Week 48, and Week 96.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  99     100  
Mean Change From Baseline in Fasting Triglycerides Associated With RETN_2265  
[units: mg/dL]
Mean ± Standard Error
   
Fasting Triglycerides: RETN_2265 WT     19.61  ± 9.17     65.83  ± 9.36  
Fasting Triglycerides: RETN_2265 MAC     28.70  ± 14.5     148.95  ± 18.3  


Statistical Analysis 1 for Mean Change From Baseline in Fasting Triglycerides Associated With RETN_2265
Groups [1] All groups
Method [2] linear mixed effect model
P Value [3] 0.0058
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Null Hypothesis: There is no association between the mean change from baseline in fasting triglycerides (phenotype) and the RETN_2265 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, weeks 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with RETN_2265 reported in Outcome Measure 16.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values <0.2 reported)
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.



20.  Primary:   Mean Change From Baseline in Fasting Triglycerides Associated With RETN_598   [ Time Frame: Baseline (Day 1), Week 48, and Week 96. ]

Measure Type Primary
Measure Title Mean Change From Baseline in Fasting Triglycerides Associated With RETN_598
Measure Description The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair.
Time Frame Baseline (Day 1), Week 48, and Week 96.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  99     100  
Mean Change From Baseline in Fasting Triglycerides Associated With RETN_598  
[units: mg/dL]
Mean ± Standard Error
   
Fasting Triglycerides: RETN_598 WT     20.23  ± 10.2     61.66  ± 10.5  
Fasting Triglycerides: RETN_598 MAC     25.78  ± 12.2     123.28  ± 14.2  


Statistical Analysis 1 for Mean Change From Baseline in Fasting Triglycerides Associated With RETN_598
Groups [1] All groups
Method [2] linear mixed effect model
P Value [3] 0.0253
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Null Hypothesis: There is no association between the mean change from baseline in fasting triglycerides (phenotype) and the RETN_598 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, week 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with RETN_598 reported in Outcome Measure 16.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values <0.2 reported)
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.



21.  Primary:   Mean Change From Baseline in Fasting Triglycerides Associated With APOE_C130R   [ Time Frame: Baseline (Day 1), Week 48, and Week 96. ]

Measure Type Primary
Measure Title Mean Change From Baseline in Fasting Triglycerides Associated With APOE_C130R
Measure Description The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair.
Time Frame Baseline (Day 1), Week 48, and Week 96.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  99     100  
Mean Change From Baseline in Fasting Triglycerides Associated With APOE_C130R  
[units: mg/dL]
Mean ± Standard Error
   
Fasting Triglycerides: APOE_C130R WT     23.27  ± 8.33     70.71  ± 9.52  
Fasting Triglycerides: APOE_C130R MAC     13.92  ± 26.0     131.56  ± 19.3  


Statistical Analysis 1 for Mean Change From Baseline in Fasting Triglycerides Associated With APOE_C130R
Groups [1] All groups
Method [2] linear mixed effect model
P Value [3] 0.1173
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Null Hypothesis: There is no association between the mean change from baseline in fasting triglycerides (phenotype) and the APOE_C130R genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, week 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with APOE_C130R reported in Outcome Measure 16.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values <0.2 reported)
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.



22.  Primary:   Mean Change From Baseline in Fasting Triglycerides Associated With RETN_734   [ Time Frame: Baseline (Day 1), Week 48, and Week 96. ]

Measure Type Primary
Measure Title Mean Change From Baseline in Fasting Triglycerides Associated With RETN_734
Measure Description The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair.
Time Frame Baseline (Day 1), Week 48, and Week 96.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  99     100  
Mean Change From Baseline in Fasting Triglycerides Associated With RETN_734  
[units: mg/dL]
Mean ± Standard Error
   
Fasting Triglycerides: RETN_734 WT     23.35  ± 8.67     75.12  ± 8.94  
Fasting Triglycerides: RETN_734 MAC     21.16  ± 20.4     155.28  ± 27.0  


Statistical Analysis 1 for Mean Change From Baseline in Fasting Triglycerides Associated With RETN_734
Groups [1] All groups
Method [2] linear mixed effect model
P Value [3] 0.1173
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Null Hypothesis: There is no association between the mean change from baseline in fasting triglycerides (phenotype) and the RETN_734 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, weeks 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with RETN_734 reported in Outcome Measure 16.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values <0.2 reported)
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.



23.  Primary:   Mean Change From Baseline in Fasting Plasminogen Activator Inhibitor (PAI)-1 Associated With APOE_R176C   [ Time Frame: Baseline (Day 1), Week 48, and Week 96. ]

Measure Type Primary
Measure Title Mean Change From Baseline in Fasting Plasminogen Activator Inhibitor (PAI)-1 Associated With APOE_R176C
Measure Description The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair.
Time Frame Baseline (Day 1), Week 48, and Week 96.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  99     100  
Mean Change From Baseline in Fasting Plasminogen Activator Inhibitor (PAI)-1 Associated With APOE_R176C  
[units: ng/dL]
Mean ± Standard Error
   
Fasting PAI-1: APOE_R176C WT     5.98  ± 8.85     7.30  ± 9.90  
Fasting PAI-1: APOE_R176C WT     -117.27  ± 37.3     -5.94  ± 38.5  


Statistical Analysis 1 for Mean Change From Baseline in Fasting Plasminogen Activator Inhibitor (PAI)-1 Associated With APOE_R176C
Groups [1] All groups
Method [2] linear mixed effect model
P Value [3] 0.1847
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Null Hypothesis: There is no association between the mean change from baseline in fasting PAI-1 (phenotype) and the APOE_R176C genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, weeks 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with APOE_R176C reported in Outcome Measure 16.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values <0.2 reported)
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.



24.  Primary:   Mean Change From Baseline in Fasting Tumor Necrosis Factor (TNF)-Alpha Associated With IL6_5309   [ Time Frame: Baseline (Day 1), Week 48, and Week 96. ]

Measure Type Primary
Measure Title Mean Change From Baseline in Fasting Tumor Necrosis Factor (TNF)-Alpha Associated With IL6_5309
Measure Description The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair.
Time Frame Baseline (Day 1), Week 48, and Week 96.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  99     100  
Mean Change From Baseline in Fasting Tumor Necrosis Factor (TNF)-Alpha Associated With IL6_5309  
[units: pg/mL]
Mean ± Standard Error
   
Fasting TNF-alpha: IL6_5309 WT     -1.19  ± 2.24     -2.68  ± 2.68  
Fasting TNF-alpha: IL6_5309 MAC     6.01  ± 1.47     1.41  ± 1.51  


Statistical Analysis 1 for Mean Change From Baseline in Fasting Tumor Necrosis Factor (TNF)-Alpha Associated With IL6_5309
Groups [1] All groups
Method [2] linear mixed effect model
P Value [3] 0.1833
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Null Hypothesis:There is no association between the mean change from baseline in fasting Tumor Necrosis Factor(TNF)-alpha (phenotype) and the IL6_5309 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, wk48 and 96) to test the overall genotype effect (ie. an omnibus test on both marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with IL6_5309 reported in Outcome Measure 16
[2] Other relevant method information, such as adjustments or degrees of freedom:
  The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values <0.2 reported)
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.



25.  Primary:   Mean Change From Baseline in Fasting Tumor Necrosis Factor (TNF)-Alpha Asssociated With RS11030679   [ Time Frame: Baseline (Day 1), Week 48, and Week 96. ]

Measure Type Primary
Measure Title Mean Change From Baseline in Fasting Tumor Necrosis Factor (TNF)-Alpha Asssociated With RS11030679
Measure Description The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair.
Time Frame Baseline (Day 1), Week 48, and Week 96.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  99     100  
Mean Change From Baseline in Fasting Tumor Necrosis Factor (TNF)-Alpha Asssociated With RS11030679  
[units: pg/mL]
Mean ± Standard Error
   
Fasting TNF-alpha: RS11030679 WT     7.58  ± 1.72     -0.13  ± 1.73  
Fasting TNF-alpha: RS11030679 MAC     0.02  ± 1.72     1.27  ± 2.00  


Statistical Analysis 1 for Mean Change From Baseline in Fasting Tumor Necrosis Factor (TNF)-Alpha Asssociated With RS11030679
Groups [1] All groups
Method [2] linear mixed effect model
P Value [3] 0.1833
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Null Hypothesis: There is no association between the mean change from baseline in fasting TNF-alpha (phenotype) and the RS11030679 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, week 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with RETN_097 reported in Outcome Measure 16.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values <0.2 reported)
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.



26.  Primary:   Mean Change From Baseline in Subcutaneous Adipose Tissue (SAT)-To-Trunk Adipose Tissue (TAT) Ratio Associated With CCDC122_5980   [ Time Frame: Baseline (Day 1), Week 48, and Week 96. ]

Measure Type Primary
Measure Title Mean Change From Baseline in Subcutaneous Adipose Tissue (SAT)-To-Trunk Adipose Tissue (TAT) Ratio Associated With CCDC122_5980
Measure Description The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair. SAT and TAT were measured by computed tomography (CT).
Time Frame Baseline (Day 1), Week 48, and Week 96.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  99     100  
Mean Change From Baseline in Subcutaneous Adipose Tissue (SAT)-To-Trunk Adipose Tissue (TAT) Ratio Associated With CCDC122_5980  
[units: cm^2]
Mean ± Standard Error
   
SAT-to-TAT Ratio: CCDC122_5980 WT     0.03  ± 0.01     0.03  ± 0.02  
SAT-to-TAT Ratio: CCDC122_5980 MAC     0.11  ± 0.02     0.02  ± 0.02  


Statistical Analysis 1 for Mean Change From Baseline in Subcutaneous Adipose Tissue (SAT)-To-Trunk Adipose Tissue (TAT) Ratio Associated With CCDC122_5980
Groups [1] All groups
Method [2] linear mixed effect model
P Value [3] 0.1694
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Null Hypothesis: There is no association between the mean change from baseline in SAT-to-TAT Ratio (phenotype) and the CCDC122_5980 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, week 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with CCDC122_5980 reported in Outcome Measure 16.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values <0.2 reported)
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.



27.  Primary:   Mean Change From Baseline in Visceral Adipose Tissue (VAT) Associated With BRUNOL_1842   [ Time Frame: Baseline (Day 1), Week 48, and Week 96. ]

Measure Type Primary
Measure Title Mean Change From Baseline in Visceral Adipose Tissue (VAT) Associated With BRUNOL_1842
Measure Description The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair. VAT was measured by computed tomography (CT).
Time Frame Baseline (Day 1), Week 48, and Week 96.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  99     100  
Mean Change From Baseline in Visceral Adipose Tissue (VAT) Associated With BRUNOL_1842  
[units: cm^2]
Mean ± Standard Error
   
VAT: BRUNOL_1842 WT     23.45  ± 6.55     10.38  ± 7.13  
VAT: BRUNOL_1842 MAC     -3.20  ± 6.18     -1.76  ± 9.32  


Statistical Analysis 1 for Mean Change From Baseline in Visceral Adipose Tissue (VAT) Associated With BRUNOL_1842
Groups [1] All groups
Method [2] linear mixed effect model
P Value [3] 0.1335
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Null Hypothesis: There is no association between the mean change from baseline in VAT (phenotype) and the BRUNOL_1842 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, week 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with BRUNOL_1842 reported in Outcome Measure 16.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values <0.2 reported)
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.



28.  Primary:   Mean Change From Baseline in VAT Associated With RETN_730   [ Time Frame: Baseline (Day 1), Week 48, and Week 96. ]

Measure Type Primary
Measure Title Mean Change From Baseline in VAT Associated With RETN_730
Measure Description The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair. VAT was measured by computed tomography (CT).
Time Frame Baseline (Day 1), Week 48, and Week 96.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  99     100  
Mean Change From Baseline in VAT Associated With RETN_730  
[units: cm^2]
Mean ± Standard Error
   
VAT: RETN_730 WT     -2.95  ± 6.10     13.69  ± 8.03  
VAT: RETN_730 MAC     23.29  ± 6.52     -1.05  ± 7.61  


Statistical Analysis 1 for Mean Change From Baseline in VAT Associated With RETN_730
Groups [1] All groups
Method [2] linear mixed effect model
P Value [3] 0.1335
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Null Hypothesis: There is no association between the mean change from baseline in VAT (phenotype) and the RETN_730 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, weeks 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with RETN_730 reported in Outcome Measure 16.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values <0.2 reported)
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.



29.  Primary:   Mean Change From Baseline in VAT-to-TAT Ratio Associated With CCDA122_5980   [ Time Frame: Baseline (Day 1), Week 48, and Week 96. ]

Measure Type Primary
Measure Title Mean Change From Baseline in VAT-to-TAT Ratio Associated With CCDA122_5980
Measure Description The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair. VAT and TAT were measured by computed tomography (CT).
Time Frame Baseline (Day 1), Week 48, and Week 96.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants with both genotypes and phenotypes available in the metabolic substudy. Phenotypes used in this analysis were from 3 time points: baseline (Week 0), Week 48, and Week 96. No additional multiple testing adjustment was applied for the number of phenotypes being analyzed.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  99     100  
Mean Change From Baseline in VAT-to-TAT Ratio Associated With CCDA122_5980  
[units: cm^2]
Mean ± Standard Error
   
VAT-to-TAT Ratio: CCDA122_5980 WT     -0.03  ± 0.01     -0.03  ± 0.02  
VAT-to-TAT Ratio: CCDA122_5980 MAC     -0.11  ± 0.02     -0.02  ± 0.02  


Statistical Analysis 1 for Mean Change From Baseline in VAT-to-TAT Ratio Associated With CCDA122_5980
Groups [1] All groups
Method [2] linear mixed effect model
P Value [3] 0.1696
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Null Hypothesis: There is no association between the mean change from baseline in VAT-to-TAT Ratio (phenotype) and the CCDA122_5980 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, weeks 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with CCDA122_5980 reported in Outcome Measure 16.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values <0.2 reported)
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.



30.  Secondary:   Number of Participants With HIV RNA < 400 c/mL at Week 48   [ Time Frame: Baseline (Day 1) and Week 48 ]

Measure Type Secondary
Measure Title Number of Participants With HIV RNA < 400 c/mL at Week 48
Measure Description HIV RNA < 400 c/mL is a less stringent measure of viral suppression (highest threshold of assay) and indicates that a participant responded to treatment.
Time Frame Baseline (Day 1) and Week 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Efficacy analyses of the treatment period are based on randomized population. In this analysis, participants who did not complete the study are counted as having failed to respond to treatment. Participants who discontinued prior to obtaining Week 48 HIV RNA levels were categorized under Non-completers.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  440     443  
Number of Participants With HIV RNA < 400 c/mL at Week 48  
[units: Participants]
  377     365  


Statistical Analysis 1 for Number of Participants With HIV RNA < 400 c/mL at Week 48
Groups [1] All groups
Method [2] Cochran-Mantel-Haenszel
Difference Estimate [3] 3.3
95% Confidence Interval ( -1.5 to 8.1 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Treatment regimens were compared by calculation of the difference in proportions (ATV/RTV–LPV/RTV) and 95% CI based on a stratified normal approximation. Analyses were stratified by the same strata as randomization—ie, HIV RNA level at enrollment and geographic region. The proportion of participants with HIV RNA below 400 copies per mL was computed within each stratum, and combined by use of a weighted average with weights proportional to stratum size (Cochran-Mantel-Haenszel weighting).
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  No text entered.



31.  Secondary:   Number of Participants With Confirmed Plasma HIV RNA < 400 c/mL at Week 48 (Defined by the Food and Drug Administration [FDA] Time to Loss of Virologic Response [TLOVR] Algorithm)   [ Time Frame: Baseline (Day 1) and Week 48 ]

Measure Type Secondary
Measure Title Number of Participants With Confirmed Plasma HIV RNA < 400 c/mL at Week 48 (Defined by the Food and Drug Administration [FDA] Time to Loss of Virologic Response [TLOVR] Algorithm)
Measure Description TLOVR defines responders at Week 48 as participants with confirmed HIV RNA <400 c/mL through Week 48 without intervening virologic rebound or treatment discontinuation. Virologic rebound is defined as confirmed on-treatment HIV RNA <400 c/mL or last on-treatment HIV RNA <400 c/mL followed by discontinuation. Participants are considered failures in this analysis if they experienced virologic rebound at or before Week 48, discontinued before Week 48, never responded by Week 48, never received study therapy or had missing HIV RNA at Week 48 and beyond.
Time Frame Baseline (Day 1) and Week 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Efficacy analyses of the treatment period are based on randomized population.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  440     443  
Number of Participants With Confirmed Plasma HIV RNA < 400 c/mL at Week 48 (Defined by the Food and Drug Administration [FDA] Time to Loss of Virologic Response [TLOVR] Algorithm)  
[units: Participants]
  377     363  

No statistical analysis provided for Number of Participants With Confirmed Plasma HIV RNA < 400 c/mL at Week 48 (Defined by the Food and Drug Administration [FDA] Time to Loss of Virologic Response [TLOVR] Algorithm)



32.  Secondary:   Reduction of log10 HIV RNA Levels From Baseline to Week 48   [ Time Frame: Baseline (Day 1) and Week 48 ]

Measure Type Secondary
Measure Title Reduction of log10 HIV RNA Levels From Baseline to Week 48
Measure Description Changes from baseline in log10 HIV RNA levels were calculated.
Time Frame Baseline (Day 1) and Week 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All treated participants with data for this parameter.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  397     379  
Reduction of log10 HIV RNA Levels From Baseline to Week 48  
[units: c/mL]
Mean ± Standard Error
  -3.09  ± 0.042     -3.13  ± 0.037  

No statistical analysis provided for Reduction of log10 HIV RNA Levels From Baseline to Week 48



33.  Secondary:   Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 48   [ Time Frame: Baseline (Day 1) and Week 48. ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 48
Measure Description Mean change from baseline in CD4 cell counts was determined.
Time Frame Baseline (Day 1) and Week 48.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All treated participants with data for this parameter.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  370     363  
Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 48  
[units: c/mm^3]
Mean ± Standard Error
  203  ± 7.1     219  ± 7.2  


Statistical Analysis 1 for Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 48
Groups [1] All groups
Method [2] 95% CI comparison of difference
Difference Estimate [3] -16.4
95% Confidence Interval ( -35.9 to 3.1 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Mean changes in CD4 cell counts from baseline at week 48 were compared between treatment regimens with 95% CIs based on stratified normal approximations and observed values.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  No text entered.



34.  Secondary:   Treatment Emergent Resistance in Isolates From Participants With Virologic Failure at Week 48   [ Time Frame: Baseline (Day 1) and Week 48 ]

Measure Type Secondary
Measure Title Treatment Emergent Resistance in Isolates From Participants With Virologic Failure at Week 48
Measure Description Participants with virologic failure are those who never suppressed (HIV RNA <400 c/mL) and were on study through Week 48, or who rebounded to HIV RNA >= 400 c/mL and those who discontinued due to insufficient viral load response. IAS=International AIDS Society, PI=protease inhibitor, RTI=reverse transcription inhibitor, TAMS=Thymidine Analogue-Associated Mutations, NRTI=non-nucleotide reverse transcriptase inhibitor, M184V= Methionine-to-valine mutation at position 184 (in reverse transcription [RT] gene), FC=fold change
Time Frame Baseline (Day 1) and Week 48  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Paired baseline and on-study HIV samples tested for genotypic resistance and phenotypic resistance. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  440     443  
Treatment Emergent Resistance in Isolates From Participants With Virologic Failure at Week 48  
[units: Participants]
   
Virologic Failure, Week 48 (HIV RNA >= 400 c/mL)     27     26  
Paired Genotypes (n = 27, 26)     17     15  
Paired Phenotypes (n= 27, 26)     18     16  
IAS-defined major PI substitutions (n = 17, 15)     1     0  
Other IAS-defined PI substitutions (n = 17, 15)     6     2  
PI phenotypic resistance (ATV/RTV FC>5.2 (n=18,16)     1     0  
PI phenotypic resistance (LPV/RTV FC >9 (n=18, 16)     0     0  
PI phenotypic resistance (Other PIs )(n=18, 16)     4     4  
RTI Substitutions , TAMS (n= 17,15)     1     1  
RTI Substitutions , M184V (n = 17,15)     3     3  
RTI phenotypic resistance, FTC FC>3.5 (n = 18, 16)     4     3  
RTI phenotypic resistance, TDF FC >1.4(n = 18, 16)     0     1  
RTI phenotypic resistance, Other NRTIs(n = 18, 16)     5     5  

No statistical analysis provided for Treatment Emergent Resistance in Isolates From Participants With Virologic Failure at Week 48



35.  Secondary:   Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Experienced Adverse Events (AEs) and Experienced AEs Leading to Discontinuation Through Week 48   [ Time Frame: From baseline (Day 1) to Week 48. ]

Measure Type Secondary
Measure Title Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Experienced Adverse Events (AEs) and Experienced AEs Leading to Discontinuation Through Week 48
Measure Description AEs:new,untoward medical occurrences/worsening of pre-existing medical condition,drug-related or not.SAEs:any AE that:resulted in death;was life threatening;resulted in a persistent or significant disability/incapacity;resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; was cancer;or overdose.Discontinuation from study was due either to an AE or was conducted at the investigator's discretion.AEs represented here include SAEs, which are not included in the AE count represented in the AE xml upload section. As such, these numbers may not match.
Time Frame From baseline (Day 1) to Week 48.  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety analyses of the treatment period are based on treated population.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  441     437  
Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Experienced Adverse Events (AEs) and Experienced AEs Leading to Discontinuation Through Week 48  
[units: Participants]
   
Deaths     6     6  
Other SAEs     51     42  
AEs     400     399  
AEs leading to discontinuation     11     15  

No statistical analysis provided for Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Experienced Adverse Events (AEs) and Experienced AEs Leading to Discontinuation Through Week 48



36.  Secondary:   Number of Participants With Laboratory Abnormalities in Hematology Through Week 48: Hemoglobin, Hematocrit, Platelet Count, International Normalized Ratio (INR), Neutrophils, Prothrombin Time (PT) and White Blood Cells (WBC)   [ Time Frame: At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48. ]

Measure Type Secondary
Measure Title Number of Participants With Laboratory Abnormalities in Hematology Through Week 48: Hemoglobin, Hematocrit, Platelet Count, International Normalized Ratio (INR), Neutrophils, Prothrombin Time (PT) and White Blood Cells (WBC)
Measure Description Hematology abnormalities were graded per modified World Health Organization (WHO) criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe). Grade 3 and 4 criteria were: Hemoglobin: Grade 3: 6.5-7.9 g/dL, Grade 4: <6.5 g/dL; Hematocrit: Grade 3: >=19.5 – 24%, Grade 4: <19.5%; platelet count: Grade 3: 20,000- 49, 999/ mm^3, Grade 4: <20,000/mm^3; INR: Grade 3 Absolute Neutrophil Count (ANC): Grade 3: >= 500 - <750/mm^3, Grade 4: <500/mm^3; PT: Grade 3: 1.51 – 3.0*ULN, Grade 4: >3*ULN; WBC: Grade 3: >=800 to <1000/mm^3, Grade 4: <80/mm^3.
Time Frame At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety analyses of the treatment period are based on treated population. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  441     437  
Number of Participants With Laboratory Abnormalities in Hematology Through Week 48: Hemoglobin, Hematocrit, Platelet Count, International Normalized Ratio (INR), Neutrophils, Prothrombin Time (PT) and White Blood Cells (WBC)  
[units: Participants]
   
Hematocrit (n= 434, 431)     0     6  
Hemoglobin (n= 434, 431)     2     6  
INR (n= 435, 431)     6     11  
Neutrophils (n = 434, 431)     14     3  
Platelets ( n= 433, 430)     5     1  
PT (n = 435, 431)     6     16  
WBC (n = 434, 431)     0     0  

No statistical analysis provided for Number of Participants With Laboratory Abnormalities in Hematology Through Week 48: Hemoglobin, Hematocrit, Platelet Count, International Normalized Ratio (INR), Neutrophils, Prothrombin Time (PT) and White Blood Cells (WBC)



37.  Secondary:   Number of Participants With Laboratory Abnormalities in Serum Enzymes Levels Through Week 48   [ Time Frame: At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48. ]

Measure Type Secondary
Measure Title Number of Participants With Laboratory Abnormalities in Serum Enzymes Levels Through Week 48
Measure Description Laboratory measurements marked as abnormal, as per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe). Grade 3 and 4 criteria in serum enzymes were: Creatine phosphokinase (CPK): Grade 3: 5.1 – 10.0 * upper limit of normal (ULN), Grade 4: >10* ULN; Lipase: Grade 3: 2.10 – 5.0* ULN, Grade 4: 5.0* ULN.
Time Frame At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety analyses of the treatment period are based on treated population.The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  441     437  
Number of Participants With Laboratory Abnormalities in Serum Enzymes Levels Through Week 48  
[units: Participants]
   
CPK (n = 435, 430)     22     20  
Lipase (n = 435, 430)     6     6  

No statistical analysis provided for Number of Participants With Laboratory Abnormalities in Serum Enzymes Levels Through Week 48



38.  Secondary:   Number of Participants With Laboratory Abnormalities in Liver Function Test Through Week 48   [ Time Frame: At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48. ]

Measure Type Secondary
Measure Title Number of Participants With Laboratory Abnormalities in Liver Function Test Through Week 48
Measure Description Liver function tests abnormalities were graded as per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe), while albumin was graded as per National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE). Grade 3 and 4 criteria were: alanine aminotransferase (ALT), aspartate aminotransferase(AST), alkaline phosphatase: Grade 3: 5.1- 10*ULN, Grade 4: >10*ULN; direct and total bilirubin: Grade 3: 2.6- 5*ULN, Grade 4: >5*ULN, Albumin: Grade 3: <2g/dL.
Time Frame At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety analyses of the treatment period are based on treated population. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  441     437  
Number of Participants With Laboratory Abnormalities in Liver Function Test Through Week 48  
[units: Participants]
   
ALT (n= 435, 431)     8     6  
AST (n = 435, 430)     9     2  
Albumin (n = 435, 431)     0     0  
Alkaline Phosphatase (n= 435, 430)     1     1  
Direct Bilirubin (n = 435, 430)     37     4  
Total Bilirubin (n = 435, 431)     146     1  

No statistical analysis provided for Number of Participants With Laboratory Abnormalities in Liver Function Test Through Week 48



39.  Secondary:   Number of Participants With Laboratory Abnormalities in Renal Function Test Through Week 48   [ Time Frame: At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, and 48. ]

Measure Type Secondary
Measure Title Number of Participants With Laboratory Abnormalities in Renal Function Test Through Week 48
Measure Description Renal function test abnormalities were graded as per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe). Grade 3 and 4 criteria were: Blood urea nitrogen (BUN): Grade 3: 5.1- 10*ULN, Grade 4: >10*ULN; Creatinine: Grade 3: 3.1 - 6*ULN, Grade 4: >6*ULN; low phosphorous (hypophosphatemia): Grade 3: 1.0- 1.4 mg/dL, Grade 4: <1.0mg/dL; high uric acid (hyperuricemia): Grade 3: 12.1 – 15.0 mg/dL, Grade 4: >15.0 mg/dL.
Time Frame At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, and 48.  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety analyses of the treatment period are based on treated population. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  441     437  
Number of Participants With Laboratory Abnormalities in Renal Function Test Through Week 48  
[units: Participants]
   
BUN (n = 435, 431)     0     0  
Creatinine (n = 435, 431)     1     1  
Phosphorus (n = 435, 431)     0     1  
Uric acid (n = 435, 431)     0     3  

No statistical analysis provided for Number of Participants With Laboratory Abnormalities in Renal Function Test Through Week 48



40.  Secondary:   Number of Participants With Laboratory Abnormalities in Electrolytes Through Week 48   [ Time Frame: At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48. ]

Measure Type Secondary
Measure Title Number of Participants With Laboratory Abnormalities in Electrolytes Through Week 48
Measure Description Serum electrolytes abnormalities,graded per modified WHOcriteria.Ranges were:hypercarbia:Grade3:41-45milliequivalents(meq)/L,Grade4:>45meq/L;hypocarbia:Grade3:10-14 meq/L,Grade4:<10 meq/L;hypercalcemia:Grade3:12.6 – 13.5 mg/dL,Grade 4:>13.5 mg/dL;hypocalcemia:6.1–6.9mg/dL,Grade4:<6.1mg/dL;hyperchloremia:Grade 3: 121-125 meq/L,Grade4:>125meq/L;hypochloremia:Grade 3:80-84 meq/L,Grade4:<80meq/L;hyperkalemia:Grade3:6.6-7.0meq/L,Grade4:>7.0meq/L;hypokalemia:Grade3:2.0-2.4 meq/L,Grade4:<2.0meq/L;hypernatremia:Grade3:158-165 meq/L,Grade4:>165meq/L;hyponatremia:Grade 3:116-122 meq/L,Grade 4:115 meq/L.
Time Frame At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety analyses of the treatment period are based on treated population. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  441     437  
Number of Participants With Laboratory Abnormalities in Electrolytes Through Week 48  
[units: Participants]
   
Hypercarbia (n = 435, 431)     0     0  
Hypocarbia (n = 435, 431)     1     7  
Hypercalcemia (n = 435, 431)     0     0  
Hypocalcemia (n = 435, 431)     1     4  
Hyperchloremia (n = 435, 431)     0     0  
Hypochloremia (n = 435, 431)     0     0  
Hyperkalemia (n = 435, 430)     0     1  
Hypokalemia (n = 435, 430)     0     1  
Hypernatremia (n = 435, 431)     0     0  
Hyponatremia (n = 435, 431)     0     1  

No statistical analysis provided for Number of Participants With Laboratory Abnormalities in Electrolytes Through Week 48



41.  Secondary:   Number of Participants With Laboratory Abnormalities in Urinalysis Through Week 48   [ Time Frame: At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48. ]

Measure Type Secondary
Measure Title Number of Participants With Laboratory Abnormalities in Urinalysis Through Week 48
Measure Description Laboratory measurements marked as abnormal, per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe), at any study time point. The following Grade 3 and 4 definitions specify the criteria for MAs in urinalysis: Proteinuria: Grade 3: 4= or >2-3.5 g loss/day, Grade 4: >3.5 g loss/day.
Time Frame At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety analyses of the treatment period are based on treated population. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  441     437  
Number of Participants With Laboratory Abnormalities in Urinalysis Through Week 48  
[units: Participants]
   
Glycosuria (n = 434, 431)     4     3  
Proteinuria (n = 434, 431)     3     1  

No statistical analysis provided for Number of Participants With Laboratory Abnormalities in Urinalysis Through Week 48



42.  Secondary:   Number of Participants With Laboratory Abnormalities in Fasting Lipids Through Week 48   [ Time Frame: At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48. ]

Measure Type Secondary
Measure Title Number of Participants With Laboratory Abnormalities in Fasting Lipids Through Week 48
Measure Description Laboratory measurements marked as abnormal, as per National Cholesterol Education Program (NCEP)- Adult Treatment Panel (ATP)-III guided categories. The following definitions specify the criteria for MAs in fasting lipids: Total cholesterol: Grade 3: 240 - 300 mg/dL, Grade 4: >=240 mg/dL, triglycerides: Grade 3: 200 - <500 mg/dL, Grade 4: >=500 mg/dL.
Time Frame At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety analyses of the treatment period are based on treated population. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  441     437  
Number of Participants With Laboratory Abnormalities in Fasting Lipids Through Week 48  
[units: Participants]
   
Total Cholesterol (n = 434, 428)     30     77  
Triglycerides (n = 434, 428)     2     15  

No statistical analysis provided for Number of Participants With Laboratory Abnormalities in Fasting Lipids Through Week 48



43.  Secondary:   Number of Participants With Laboratory Abnormalities in Fasting Glucose Through Week 48   [ Time Frame: At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48. ]

Measure Type Secondary
Measure Title Number of Participants With Laboratory Abnormalities in Fasting Glucose Through Week 48
Measure Description Laboratory measurements marked as abnormal, per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe), at any study time point. The following Grade 3 and 4 definitions specify the criteria for MAs in fasting glucose: hypoglycemia: Grade 3: 30-39 mg/dL, Grade 4: <30 mg/dL; hyperglycemia: 251-500 mg/dL, Grade 4: >500 mg/dL.
Time Frame At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety analyses of the treatment period are based on treated population. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  441     437  
Number of Participants With Laboratory Abnormalities in Fasting Glucose Through Week 48  
[units: Participants]
   
Hyperglycemia (n = 434, 428)     1     1  
Hypoglycemia (n = 434, 428)     0     0  

No statistical analysis provided for Number of Participants With Laboratory Abnormalities in Fasting Glucose Through Week 48



44.  Secondary:   Mean Change in Weight From Baseline at Week 48   [ Time Frame: Baseline (Day 1) and Week 48 ]

Measure Type Secondary
Measure Title Mean Change in Weight From Baseline at Week 48
Measure Description Mean change in body weight from baseline was determined.
Time Frame Baseline (Day 1) and Week 48  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety analyses of the treatment period are based on treated population, who had values for this parameter.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  395     370  
Mean Change in Weight From Baseline at Week 48  
[units: kg]
Mean ± Standard Error
  4.0  ± 0.3     2.0  ± 0.3  

No statistical analysis provided for Mean Change in Weight From Baseline at Week 48



45.  Secondary:   Mean Change in Body Mass Index (BMI) in Participants at Week 48   [ Time Frame: Baseline (Day 1) and Week 48 ]

Measure Type Secondary
Measure Title Mean Change in Body Mass Index (BMI) in Participants at Week 48
Measure Description Mean change in BMI from baseline at Week 48 was determined.
Time Frame Baseline (Day 1) and Week 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety analyses of the treatment period are based on treated population, who had values for this parameter.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  393     370  
Mean Change in Body Mass Index (BMI) in Participants at Week 48  
[units: kg/m^2]
Mean ± Standard Error
  1.3  ± 0.10     0.8  ± 0.10  

No statistical analysis provided for Mean Change in Body Mass Index (BMI) in Participants at Week 48



46.  Secondary:   Mean Change in Fasting Lipid at Week 48   [ Time Frame: Baseline (Day 1) and Week 48. ]

Measure Type Secondary
Measure Title Mean Change in Fasting Lipid at Week 48
Measure Description Mean change from baseline in fasting lipids, for fasting total cholesterol, LDL cholesterol, HDL cholesterol, non-HDL cholesterol, and triglycerides at Week 48 were determined.
Time Frame Baseline (Day 1) and Week 48.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety analyses of the treatment period are based on treated population.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  441     437  
Mean Change in Fasting Lipid at Week 48  
[units: milligrams/deciliter (mg/dL)]
Mean ± Standard Error
   
Fasting total Cholesterol (n=373, 337)     19  ± 1.6     38  ± 1.8  
Fasting HDL Cholesterol (n=371, 335)     9  ± 0.6     12  ± 0.6  
Fasting Non-HDL Cholesterol (n=371, 335)     10  ± 1.5     26  ± 1.7  
Fasting LDL Cholesterol (n=372, 335)     12  ± 1.4     18  ± 1.5  
Fasting Triglycerides (n=373, 337)     20  ± 4.0     70  ± 5.7  

No statistical analysis provided for Mean Change in Fasting Lipid at Week 48



47.  Secondary:   Mean Change in Fasting Glucose at Week 48   [ Time Frame: Baseline (Day 1) and Week 48. ]

Measure Type Secondary
Measure Title Mean Change in Fasting Glucose at Week 48
Measure Description Mean change from baseline in fasting glucose at Week 48.
Time Frame Baseline (Day 1) and Week 48.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety analyses of the treatment period are based on treated population with values for this parameter.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  383     363  
Mean Change in Fasting Glucose at Week 48  
[units: mg/dL]
Mean ± Standard Error
  2  ± 0.6     0  ± 1.3  

No statistical analysis provided for Mean Change in Fasting Glucose at Week 48



48.  Secondary:   Mean Change in Fasting Insulin at Week 48   [ Time Frame: Baseline (Day 1) and Week 48. ]

Measure Type Secondary
Measure Title Mean Change in Fasting Insulin at Week 48
Measure Description Mean change from baseline in fasting insulin at Week 48.
Time Frame Baseline (Day 1) and Week 48.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety analyses of the treatment period are based on treated population with values for this parameter.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  371     352  
Mean Change in Fasting Insulin at Week 48  
[units: micro units (µU)/mL]
Mean ± Standard Error
  2.5  ± 0.52     0.2  ± 0.38  

No statistical analysis provided for Mean Change in Fasting Insulin at Week 48



49.  Secondary:   Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey - Human Immunodeficiency Virus (MOS-HIV) at Week 24   [ Time Frame: Baseline (Day 1) and Week 24. ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey - Human Immunodeficiency Virus (MOS-HIV) at Week 24
Measure Description Medical Outcomes Study HIV Health Survey (MOS-HIV) is developed to assess a patient's health and functional status associated with HIV infection. The MOS-HIV questionnaire is applied to participants with adequate linguistic skills. The subscale and summary scores range from 0-100 with a higher score indicating better health.
Time Frame Baseline (Day 1) and Week 24.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As-treated participants with evaluable baseline MOS-HIV . The 'n' is signifying those participants who were evaluated for this measure at the timepoint for each group respectively.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  347     351  
Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey - Human Immunodeficiency Virus (MOS-HIV) at Week 24  
[units: Units on Scale]
Mean ± Standard Error
   
Physical Health Summary (317, 314)     4.1  ± 0.46     3.3  ± 0.46  
Mental Health Summary (317, 314)     5.3  ± 0.50     4.8  ± 0.52  
Overall Health Perception Subscale (325, 320)     15.2  ± 1.31     13.0  ± 1.41  
Physical Function Subscale (324, 325)     7.6  ± 1.25     5.0  ± 1.30  
Role Function Subscale (325, 325)     10.6  ± 1.72     6.5  ± 1.61  
Social Function Subscale (327, 322)     8.5  ± 1.54     7.1  ± 1.49  
Cognitive Function Subscale (326, 324)     5.6  ± 1.11     3.0  ± 0.94  
Pain Subscale (327, 325)     7.4  ± 1.37     8.6  ± 1.23  
Mental Health Subscale (325, 326)     6.4  ± 1.09     7.4  ± 1.08  
Energy/Fatigue Subscale (323, 326)     7.1  ± 1.16     7.5  ± 1.14  
Health Distress Subscale (323, 326)     14.4  ± 1.29     13.9  ± 1.30  
Quality of Life Subscale (327, 326)     9.9  ± 1.32     7.1  ± 1.29  
Health Transition Subscale (327, 326)     13.1  ± 1.64     10.7  ± 1.55  

No statistical analysis provided for Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey - Human Immunodeficiency Virus (MOS-HIV) at Week 24



50.  Secondary:   Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey - Human Immunodeficiency Virus (MOS-HIV) at Week 48   [ Time Frame: Baseline (Day 1) and Week 48 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey - Human Immunodeficiency Virus (MOS-HIV) at Week 48
Measure Description MOS-HIV is developed to assess a participant's health and functional status associated with HIV infection. The questionnaire is applied to participants with adequate linguistic skills and consists of 35 items. The questionnaire derives an overall health score and 10 subscale scores (health transitions, pain, physical functioning, role functioning, social functioning, cognitive functioning, mental health, energy/fatigue, health distress and quality of life).The subscale and summary scores range from 0-100 with a higher score indicating better health.
Time Frame Baseline (Day 1) and Week 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants analyzed are as-treated participants with evaluable baseline MOS-HIV. The 'n' is signifying those participants who were evaluated for this measure at the timepoint for each group respectively.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  347     351  
Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey - Human Immunodeficiency Virus (MOS-HIV) at Week 48  
[units: Units on Scale]
Mean ± Standard Error
   
Physical Health Summary (296, 287)     3.8  ± 0.50     3.3  ± 0.49  
Mental Health Summary (296, 287)     6.0  ± 0.54     5.6  ± 0.54  
Overall Health Perception Subscale (305, 297)     15.6  ± 1.53     13.7  ± 1.51  
Physical Function Subscale (303, 298)     5.8  ± 1.28     5.3  ± 1.24  
Role Function Subscale (307, 298)     8.5  ± 1.75     8.1  ± 1.75  
Social Function Subscale (308, 295)     9.2  ± 1.48     7.4  ± 1.66  
Cognitive Function Subscale (307, 300)     4.8  ± 1.25     5.6  ± 1.05  
Pain Subscale (308, 297)     8.3  ± 1.39     8.0  ± 1.39  
Mental Health Subscale (306, 300)     8.3  ± 1.21     8.7  ± 1.10  
Energy/Fatigue Subscale (304, 300)     8.4  ± 1.25     7.9  ± 1.21  
Health Distress Subscale (304, 300)     14.3  ± 1.39     15.0  ± 1.36  
Quality of Life Subscale (308, 300)     12.9  ± 1.39     8.4  ± 1.34  
Health Transition Subscale (308, 300)     11.0  ± 1.63     8.8  ± 1.64  

No statistical analysis provided for Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey - Human Immunodeficiency Virus (MOS-HIV) at Week 48



51.  Secondary:   Mean Change From Baseline (BL) in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 4 (IBS-QoL)   [ Time Frame: IBS-QoL is administered at baseline (Day 1) and Week 4. ]

Measure Type Secondary
Measure Title Mean Change From Baseline (BL) in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 4 (IBS-QoL)
Measure Description The IBS-QoL questionnaire has 34 items and an overall score and 8 subscale scores: dysphoria,interference with activity,body image,health worry, food avoidance,social reaction,sexual, and relationships. Overall and subscores transformed to a 0-100 scale (0=lowest score, 100=highest possible score). Scores between these values represent the percentage of the total possible score achieved. Higher scores=better IBS-related QoL. A 14-point change from BL in IBS-QoL score in women with moderate to severe functional bowel disorders is a minimally important difference based on pain and satisfaction.
Time Frame IBS-QoL is administered at baseline (Day 1) and Week 4.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As treated participants with evaluable baseline IBS-QOL. The 'n' is signifying those participants were evaluated for this measure at the timepoint for each group respectively.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  343     349  
Mean Change From Baseline (BL) in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 4 (IBS-QoL)  
[units: Units on Scale]
Mean ± Standard Error
   
Overall (306, 316)     3.2  ± 0.71     -0.7  ± 0.66  
Dysphoria (317, 325)     3.3  ± 0.79     -0.1  ± 0.75  
Interference with activity (319, 327)     3.1  ± 0.86     -1.9  ± 0.79  
Body image (321, 329)     1.6  ± 0.71     -1.3  ± 0.68  
Health worry (319, 330)     6.0  ± 0.96     2.0  ± 0.99  
Food avoidance (319, 329)     4.0  ± 1.03     -1.7  ± 1.07  
Social reaction (316, 327)     1.9  ± 0.76     -0.8  ± 0.71  
Sexual (320, 329)     3.7  ± 1.06     -0.1  ± 1.02  
Relationships (321, 328)     1.2  ± 0.72     -0.6  ± 0.75  

No statistical analysis provided for Mean Change From Baseline (BL) in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 4 (IBS-QoL)



52.  Secondary:   Mean Change From Baseline in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 12 (IBS-QoL)   [ Time Frame: IBS-QoL is administered at baseline (Day 1) and Week 12. ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 12 (IBS-QoL)
Measure Description The IBS-QoL questionnaire has 34 items and an overall score and 8 subscale scores: dysphoria,interference with activity,body image,health worry, food avoidance,social reaction,sexual, and relationships. Overall and subscores transformed to a 0-100 scale (0=lowest score, 100=highest possible score). Scores between these values represent the percentage of the total possible score achieved. Higher scores=better IBS-related QoL. A 14-point change from BL in IBS-QoL score in women with moderate to severe functional bowel disorders is a minimally important difference based on pain and satisfaction.
Time Frame IBS-QoL is administered at baseline (Day 1) and Week 12.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As treated participants with evaluable baseline IBS-QOL. The 'n' is signifying those participants were evaluated for this measure at the timepoint for each group respectively.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  343     349  
Mean Change From Baseline in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 12 (IBS-QoL)  
[units: Units on Scale]
Mean ± Standard Error
   
Overall (301. 310)     4.6  ± 0.69     0.2  ± 0.89  
Dysphoria (308, 319)     4.7  ± 0.79     1.2  ± 0.94  
Interference with activity (310, 320)     5.1  ± 0.83     -0.4  ± 0.96  
Body image (316, 321)     2.1  ± 0.69     -0.1  ± 0.85  
Health worry (312, 320)     7.9  ± 1.02     3.6  ± 1.23  
Food avoidance (316, 322)     5.6  ± 0.95     -0.6  ± 1.25  
Social reaction (311, 316)     3.3  ± 0.73     -0.4  ± 0.95  
Sexual (317, 321)     4.7  ± 1.11     -0.4  ± 1.19  
Relationships (313, 320)     3.5  ± 0.75     0.0  ± 0.99  

No statistical analysis provided for Mean Change From Baseline in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 12 (IBS-QoL)



53.  Secondary:   Mean Change From Baseline in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 24 Using the Irritable Bowel Syndrome Quality of Life (IBS-QoL)   [ Time Frame: Baseline (Day 1) and Week 24 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 24 Using the Irritable Bowel Syndrome Quality of Life (IBS-QoL)
Measure Description The IBS-QoL questionnaire has 34 items and an overall score and 8 subscale scores: dysphoria,interference with activity,body image,health worry, food avoidance,social reaction,sexual, and relationships. Overall and subscores transformed to a 0-100 scale (0=lowest score, 100=highest possible score). Scores between these values represent the percentage of the total possible score achieved. Higher scores=better IBS-related QoL. A 14-point change from BL in IBS-QoL score in women with moderate to severe functional bowel disorders is a minimally important difference based on pain and satisfaction.
Time Frame Baseline (Day 1) and Week 24  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As treated participants with evaluable baseline IBS-QOL. The 'n' is signifying those participants were evaluated for this measure at the timepoint for each group respectively.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  343     349  
Mean Change From Baseline in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 24 Using the Irritable Bowel Syndrome Quality of Life (IBS-QoL)  
[units: Units on a scale]
Mean ± Standard Error
   
Overall (290, 289)     4.3  ± 0.77     1.4  ± 0.88  
Dysphoria (295, 298)     4.4  ± 0.84     1.8  ± 0.97  
Interference with activity (294, 297)     4.4  ± 0.92     0.0  ± 1.04  
Body image (299, 300)     1.8  ± 0.80     1.1  ± 0.84  
Health worry (297, 300)     7.5  ± 0.99     5.3  ± 1.18  
Food avoidance (299, 300)     5.6  ± 1.14     0.4  ± 1.29  
Social reaction (295, 297)     3.2  ± 0.80     0.4  ± 0.92  
Sexual (299, 299)     4.3  ± 1.20     0.8  ± 1.15  
Relationships (297, 297)     3.3  ± 0.89     1.2  ± 1.00  

No statistical analysis provided for Mean Change From Baseline in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 24 Using the Irritable Bowel Syndrome Quality of Life (IBS-QoL)



54.  Secondary:   Number of Participants Who Adhered to Regimen as Measured by Multicenter AIDS Cohort Study Adherence Questionnaire (MACS) at Week 48   [ Time Frame: Week 48 ]

Measure Type Secondary
Measure Title Number of Participants Who Adhered to Regimen as Measured by Multicenter AIDS Cohort Study Adherence Questionnaire (MACS) at Week 48
Measure Description The MACS adherence questionnaire asks patients how many medication doses they missed during the previous day, 2 days, 3 days and 4 days. Adherence to regimen was defined as taking 100% of medicine (all doses and numbers of pills as prescribed for each medicine). This strict adherence cut-off was based on the guidelines stating that anything less than excellent adherence may result in a virus breakthrough and development of resistance.
Time Frame Week 48  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The 'n' is signifying those participants who were evaluated for this measure at the timepoint for each group respectively.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  401     378  
Number of Participants Who Adhered to Regimen as Measured by Multicenter AIDS Cohort Study Adherence Questionnaire (MACS) at Week 48  
[units: Participants]
  330     316  

No statistical analysis provided for Number of Participants Who Adhered to Regimen as Measured by Multicenter AIDS Cohort Study Adherence Questionnaire (MACS) at Week 48



55.  Secondary:   Number of Participants With HIV RNA < 50 c/mL) at Week 96   [ Time Frame: Baseline (Day 1) and Week 96 ]

Measure Type Secondary
Measure Title Number of Participants With HIV RNA < 50 c/mL) at Week 96
Measure Description HIV RNA < 50 c/mL is the most stringent measure of viral suppression (lowest threshold of assay) and indicates that a participant has responded to treatment.
Time Frame Baseline (Day 1) and Week 96  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Efficacy analyses of the treatment period are based on randomized population. In this analysis, participants who did not complete the study are counted as having failed to respond to treatment. Participants who discontinued prior to obtaining Week 96 HIV RNA levels were categorized under Non-completers.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  440     443  
Number of Participants With HIV RNA < 50 c/mL) at Week 96  
[units: Participants]
  327     302  


Statistical Analysis 1 for Number of Participants With HIV RNA < 50 c/mL) at Week 96
Groups [1] All groups
Method [2] Cochran-Mantel-Haenszel
Difference Estimate [3] 6.1
95% Confidence Interval ( 0.3 to 12.0 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Treatment regimens compared by calculation of the difference in proportions (atazanavir/ritonavir– lopinavir/ritonavir) and 95% CI based on stratified normal approximation.Analyses were stratified by the same strata as randomization—HIV RNA level at enrollment and geographic region.The proportion of participants with HIV RNA below 50 copies/mL was computed within each stratum, and combined by use of a weighted average with weights proportional to stratum size:Cochran-Mantel-Haenszel weighting
[2] Other relevant method information, such as adjustments or degrees of freedom:
  The ATV/RTV regimen was deemed to be non-inferior to the lopinavir/ritonavir regimen if the lower CI for the difference in proportions > –10%.
[3] Other relevant estimation information:
  No text entered.



56.  Secondary:   Number of Participants With HIV RNA < 400 c/mL) at Week 96   [ Time Frame: Baseline (Day 1) and Week 96 ]

Measure Type Secondary
Measure Title Number of Participants With HIV RNA < 400 c/mL) at Week 96
Measure Description HIV RNA <400 c/mL is a less stringent measure of viral suppression (highest threshold of assay) and indicates that a participant has responded to treatment.
Time Frame Baseline (Day 1) and Week 96  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Efficacy analyses of the treatment period are based on randomized population. In this analysis, participants who did not complete the study are counted as having failed to respond to treatment. Participants who discontinued prior to obtaining Week 96 HIV RNA levels were categorized under Non-completers.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  440     443  
Number of Participants With HIV RNA < 400 c/mL) at Week 96  
[units: Participants]
  350     330  


Statistical Analysis 1 for Number of Participants With HIV RNA < 400 c/mL) at Week 96
Groups [1] All groups
Method [2] Cochran-Mantel-Haenszel
Difference Estimate [3] 5.1
95% Confidence Interval ( -0.4 to 10.6 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Treatment regimens were compared by calculation of the difference in proportions (ATV/RTV–LPV/RTV) and 95% CI based on a stratified normal approximation. Analyses were stratified by the same strata as randomization—ie, HIV RNA level at enrollment and geographic region. The proportion of participants with HIV RNA below 400 copies per mL was computed within each stratum, and combined by use of a weighted average with weights proportional to stratum size (Cochran-Mantel-Haenszel weighting).
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  No text entered.



57.  Secondary:   Reduction of log10 HIV RNA Levels From Baseline at Week 96   [ Time Frame: Baseline (Day 1) and Week 96 ]

Measure Type Secondary
Measure Title Reduction of log10 HIV RNA Levels From Baseline at Week 96
Measure Description Changes from baseline in log10 HIV RNA levels were calculated.
Time Frame Baseline (Day 1) and Week 96  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Efficacy analyses of the treatment period are based on as-randomized population with values for this parameter. log10 HIV RNA changes from baseline were summarized at Week 96 using observed values.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  360     340  
Reduction of log10 HIV RNA Levels From Baseline at Week 96  
[units: c/mL]
Mean ± Standard Error
  -3.21  ± 0.034     -3.19  ± 0.036  

No statistical analysis provided for Reduction of log10 HIV RNA Levels From Baseline at Week 96



58.  Secondary:   Mean Change From Baseline in CD4 Cell Count at Week 96   [ Time Frame: Baseline (Day 1) and Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in CD4 Cell Count at Week 96
Measure Description Mean change from baseline in CD4 count among treated participants was determined.
Time Frame Baseline (Day 1) and Week 96  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Efficacy analyses of the treatment period are based on as-randomized population with values for this parameter.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  336     317  
Mean Change From Baseline in CD4 Cell Count at Week 96  
[units: cells/mm^3]
Mean ± Standard Error
  268  ± 7.6     290  ± 8.7  


Statistical Analysis 1 for Mean Change From Baseline in CD4 Cell Count at Week 96
Groups [1] All groups
Method [2] 95% CI comparison of difference
Difference Estimate [3] -21.2
95% Confidence Interval ( -43.3 to 0.9 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Mean changes in CD4 cell counts from baseline at week 48 were compared between treatment regimens with 95% CIs based on stratified normal approximations and observed values.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  No text entered.



59.  Secondary:   Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Experienced Adverse Events (AEs) and Experienced Events Leading to Discontinuation Through Week 96   [ Time Frame: From Day 1 through Week 96 ]

Measure Type Secondary
Measure Title Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Experienced Adverse Events (AEs) and Experienced Events Leading to Discontinuation Through Week 96
Measure Description AEs:new,untoward medical occurrences/worsening of pre-existing medical condition,drug-related or not.SAEs:any AE that:resulted in death;was life threatening;resulted in a persistent or significant disability/incapacity;resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; was cancer;or overdose.Discontinuation from study was due either to an AE or was conducted at the investigator's discretion.AEs represented here include SAEs, which are not included in the AE count represented in the AE xml upload section. As such, these numbers may not match.
Time Frame From Day 1 through Week 96  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety analyses of the treatment period are based on treated population.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  441     437  
Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Experienced Adverse Events (AEs) and Experienced Events Leading to Discontinuation Through Week 96  
[units: Participants]
   
Deaths     6     6  
Serious Adverse Events (SAEs)     63     50  
Adverse Events (AEs) leading to discontinuation     13     22  

No statistical analysis provided for Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Experienced Adverse Events (AEs) and Experienced Events Leading to Discontinuation Through Week 96



60.  Secondary:   Mean Changes in Fasting Lipids at Week 96   [ Time Frame: At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96. ]

Measure Type Secondary
Measure Title Mean Changes in Fasting Lipids at Week 96
Measure Description Mean change from baseline in fasting lipids at Week 96 was determined.
Time Frame At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety analyses of the treatment period are based on treated population.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  441     437  
Mean Changes in Fasting Lipids at Week 96  
[units: mg/dL]
Mean ± Standard Error
   
Fasting total Cholesterol (n=342, 291)     20  ± 1.8     37  ± 1.8  
Fasting HDL Cholesterol (n=341, 291)     7.0  ± 0.6     10.0  ± 0.7  
Fasting Non-HDL Cholesterol (n=341, 291)     13.0  ± 1.6     27.0  ± 1.7  
Fasting LDL Cholesterol (n=342, 291)     12.0  ± 1.5     17.0  ± 1.5  
Fasting Triglycerides (n=342, 291)     16.0  ± 4.4     63.0  ± 5.4  

No statistical analysis provided for Mean Changes in Fasting Lipids at Week 96



61.  Secondary:   Mean Changes in Fasting Glucose at Week 96   [ Time Frame: Baseline (Day 1) and Week 96 ]

Measure Type Secondary
Measure Title Mean Changes in Fasting Glucose at Week 96
Measure Description Mean change from baseline in fasting glucose at Week 96 was determined.
Time Frame Baseline (Day 1) and Week 96  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety analyses of the treatment period are based on treated population with values for this parameter.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  355     330  
Mean Changes in Fasting Glucose at Week 96  
[units: mg/dL]
Mean ± Standard Error
  4.0  ± 1.2     1.0  ± 1.4  

No statistical analysis provided for Mean Changes in Fasting Glucose at Week 96



62.  Secondary:   Mean Changes in Fasting Insulin at Week 96   [ Time Frame: Baseline (Day 1) and Week 96. ]

Measure Type Secondary
Measure Title Mean Changes in Fasting Insulin at Week 96
Measure Description Mean change from baseline in fasting insulin at Week 96.
Time Frame Baseline (Day 1) and Week 96.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety analyses of the treatment period are based on treated population with values for this parameter.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  349     324  
Mean Changes in Fasting Insulin at Week 96  
[units: µU/mL]
Mean ± Standard Error
  0.1  ± 0.47     -0.8  ± 0.43  

No statistical analysis provided for Mean Changes in Fasting Insulin at Week 96



63.  Secondary:   Number of Participants With Laboratory Abnormalities in Hematology: Hemoglobin, Hematocrit, Platelet Count, INR, Neutrophils, PT and WBC Through Week 96   [ Time Frame: At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96. ]

Measure Type Secondary
Measure Title Number of Participants With Laboratory Abnormalities in Hematology: Hemoglobin, Hematocrit, Platelet Count, INR, Neutrophils, PT and WBC Through Week 96
Measure Description Hematology abnormalities were graded per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe). Grade 3 and 4 criteria were: Hemoglobin: Grade 3: 6.5-7.9 g/dL, Grade 4: <6.5 g/dL; Hematocrit: Grade 3: >=19.5 – 24%, Grade 4: <19.5%; platelet count: Grade 3: 20,000- 49, 999/ mm^3, Grade 4: <20,000/mm^3; INR: Grade 3 Absolute Neutrophil Count (ANC): Grade 3: >= 500 - <750/mm^3, Grade 4: <500/mm^3; PT: Grade 3: 1.51 – 3.0*ULN, Grade 4: >3*ULN; WBC: Grade 3: >=800 to <1000/mm^3, Grade 4: <80/mm^3.
Time Frame At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety analyses of the treatment period are based on treated population. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  441     437  
Number of Participants With Laboratory Abnormalities in Hematology: Hemoglobin, Hematocrit, Platelet Count, INR, Neutrophils, PT and WBC Through Week 96  
[units: Participants]
   
Hematocrit (n= 434, 431)     0     6  
Hemoglobin (n= 434, 431)     3     7  
INR (n= 435, 431)     7     18  
Neutrophils (n = 434, 431)     21     7  
Platelets ( n= 433, 431)     5     1  
Prothrombin time (n = 435, 431)     9     24  
WBC (n = 434, 431)     0     1  

No statistical analysis provided for Number of Participants With Laboratory Abnormalities in Hematology: Hemoglobin, Hematocrit, Platelet Count, INR, Neutrophils, PT and WBC Through Week 96



64.  Secondary:   Number of Participants With Laboratory Abnormalities in Serum Enzyme Levels Through Week 96   [ Time Frame: At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96. ]

Measure Type Secondary
Measure Title Number of Participants With Laboratory Abnormalities in Serum Enzyme Levels Through Week 96
Measure Description Laboratory measurements marked as abnormal, as per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe). Grade 3 and 4 criteria in serum enzymes were: CPK: Grade 3: 5.1 – 10.0 * ULN, Grade 4: >10* ULN; Lipase: Grade 3: 2.10 – 5.0* ULN, Grade 4: 5.0* ULN.
Time Frame At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety analyses of the treatment period are based on treated population.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  441     437  
Number of Participants With Laboratory Abnormalities in Serum Enzyme Levels Through Week 96  
[units: Participants]
   
CPK (n=435, 430)     34     28  
Lipase (n=435, 430)     9     9  

No statistical analysis provided for Number of Participants With Laboratory Abnormalities in Serum Enzyme Levels Through Week 96



65.  Secondary:   Number of Participants With Laboratory Abnormalities in Liver Function Test Through Week 96   [ Time Frame: At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96. ]

Measure Type Secondary
Measure Title Number of Participants With Laboratory Abnormalities in Liver Function Test Through Week 96
Measure Description Liver function tests abnormalities were graded as per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe), while albumin was graded as per NCI-CTCAE. Grade 3 and 4 criteria were: ALT, AST, alkaline phosphatase: Grade 3: 5.1- 10*ULN, Grade 4: >10*ULN; direct and total bilirubin: Grade 3: 2.6- 5*ULN, Grade 4: >5*ULN, Albumin: Grade 3: <2g/dL.
Time Frame At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety analyses of the treatment period are based on treated population. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  441     437  
Number of Participants With Laboratory Abnormalities in Liver Function Test Through Week 96  
[units: Participants]
   
ALT (n= 435, 431)     11     7  
AST (n = 435, 430)     11     5  
Albumin (n = 435, 431)     0     0  
Alkaline Phosphatase (n= 435, 430)     1     1  
Total Bilirubin (n = 435, 431)     192     3  

No statistical analysis provided for Number of Participants With Laboratory Abnormalities in Liver Function Test Through Week 96



66.  Secondary:   Number of Participants With Laboratory Abnormalities in Renal Function Test Through Week 96   [ Time Frame: At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96. ]

Measure Type Secondary
Measure Title Number of Participants With Laboratory Abnormalities in Renal Function Test Through Week 96
Measure Description Renal function test abnormalities were graded as per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe). Grade 3 and 4 criteria were: BUN: Grade 3: 5.1- 10*ULN, Grade 4: >10*ULN; Creatinine: Grade 3: 3.1 - 6*ULN, Grade 4: >6*ULN; low phosphorous (hypophosphatemia): Grade 3: 1.0- 1.4 mg/dL, Grade 4: <1.0mg/dL; high uric acid (hyperuricemia): Grade 3: 12.1 – 15.0 mg/dL, Grade 4: >15.0 mg/dL.
Time Frame At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety analyses of the treatment period are based on treated population.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  441     437  
Number of Participants With Laboratory Abnormalities in Renal Function Test Through Week 96  
[units: Participants]
   
BUN (n = 435,431)     0     0  
Creatine (n = 435, 431)     1     2  
Phosphorous (n = 435, 431)     0     1  
Uric acid (n = 435, 431)     1     4  

No statistical analysis provided for Number of Participants With Laboratory Abnormalities in Renal Function Test Through Week 96



67.  Secondary:   Number of Participants With Laboratory Abnormalities in Electrolytes Level Through Week 96   [ Time Frame: At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96. ]

Measure Type Secondary
Measure Title Number of Participants With Laboratory Abnormalities in Electrolytes Level Through Week 96
Measure Description Serum electrolytes abnormalities,graded per modified WHOcriteria.Ranges were:hypercarbia:Grade3:41-45milliequivalents(meq)/L,Grade4:>45meq/L;hypocarbia:Grade3:10-14 meq/L,Grade4:<10 meq/L;hypercalcemia:Grade3:12.6 – 13.5 mg/dL,Grade 4:>13.5 mg/dL;hypocalcemia:6.1–6.9mg/dL,Grade4:<6.1mg/dL;hyperchloremia:Grade 3: 121-125 meq/L,Grade4:>125meq/L;hypochloremia:Grade 3:80-84 meq/L,Grade4:<80meq/L;hyperkalemia:Grade3:6.6-7.0meq/L,Grade4:>7.0meq/L;hypokalemia:Grade3:2.0-2.4 meq/L,Grade4:<2.0meq/L;hypernatremia:Grade3:158-165 meq/L,Grade4:>165meq/L;hyponatremia:Grade 3:116-122 meq/L,Grade 4:115 meq/L.
Time Frame At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety analyses of the treatment period are based on treated population.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  441     437  
Number of Participants With Laboratory Abnormalities in Electrolytes Level Through Week 96  
[units: Participants]
   
Hypercarbia (n = 435, 431)     0     0  
Hypocarbia (n = 435, 431)     4     8  
Hypercalcemia (n = 435, 431)     0     0  
Hypocalcemia (n = 435, 431)     1     4  
Hyperchloremia (n = 435, 431)     0     0  
Hypochloremia (n = 435, 431)     0     2  
Hyperkalemia (n = 435, 430)     0     1  
Hypokalemia (n = 435, 430)     0     1  
Hypernatremia (n = 435, 431)     1     2  
Hyponatremia (n = 435, 431)     0     2  

No statistical analysis provided for Number of Participants With Laboratory Abnormalities in Electrolytes Level Through Week 96



68.  Secondary:   Number of Participants With Laboratory Abnormalities in Fasting Lipids Level Through Week 96   [ Time Frame: At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96. ]

Measure Type Secondary
Measure Title Number of Participants With Laboratory Abnormalities in Fasting Lipids Level Through Week 96
Measure Description Laboratory measurements marked as abnormal, as per NCEP-ATP-III guided categories. The following definitions specify the criteria for MAs in fasting lipids: Total cholesterol: Grade 3: 240 - 300 mg/dL, Grade 4: >=240 mg/dL, triglycerides: Grade 3: 200 - <500 mg/dL, Grade 4: >=500 mg/dL.
Time Frame At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety analyses of the treatment period are based on treated population.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  441     437  
Number of Participants With Laboratory Abnormalities in Fasting Lipids Level Through Week 96  
[units: Participants]
   
Total Cholesterol (n = 434, 428)     47     108  
Triglycerides (n = 434, 428)     3     18  

No statistical analysis provided for Number of Participants With Laboratory Abnormalities in Fasting Lipids Level Through Week 96



69.  Secondary:   Number of Participants With Laboratory Abnormalities in Fasting Glucose Levels Through Week 96   [ Time Frame: At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96. ]

Measure Type Secondary
Measure Title Number of Participants With Laboratory Abnormalities in Fasting Glucose Levels Through Week 96
Measure Description Laboratory measurements marked as abnormal, per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe), at any study time point. The following Grade 3 and 4 definitions specify the criteria for MAs in fasting glucose: hypoglycemia: Grade 3: 30-39 mg/dL, Grade 4: <30 mg/dL; hyperglycemia: 251-500 mg/dL, Grade 4: >500 mg/dL.
Time Frame At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety analyses of the treatment period are based on treated population.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  441     437  
Number of Participants With Laboratory Abnormalities in Fasting Glucose Levels Through Week 96  
[units: Participants]
   
Hyperglycemia (n = 434, 428)     3     2  
Hypoglycemia (n = 434, 428)     1     0  

No statistical analysis provided for Number of Participants With Laboratory Abnormalities in Fasting Glucose Levels Through Week 96



70.  Secondary:   Number of Participants With Laboratory Abnormalities in Urinalysis Through Week 96   [ Time Frame: At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96. ]

Measure Type Secondary
Measure Title Number of Participants With Laboratory Abnormalities in Urinalysis Through Week 96
Measure Description Laboratory measurements marked as abnormal, per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe), at any study time point. The following Grade 3 and 4 definitions specify the criteria for MAs in urinalysis: Proteinuria: Grade 3: 4= or >2-3.5 g loss/day, Grade 4: >3.5 g loss/day.
Time Frame At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety analyses of the treatment period are based on treated population.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  441     437  
Number of Participants With Laboratory Abnormalities in Urinalysis Through Week 96  
[units: Participants]
   
Glycosuria (n = 434, 431)     6     5  
Proteinuria (n = 434, 431)     5     6  

No statistical analysis provided for Number of Participants With Laboratory Abnormalities in Urinalysis Through Week 96



71.  Secondary:   Number of Participants With Virologic Failure Showing Treatment Emergent Resistance Through Week 96   [ Time Frame: Baseline (Day 1) and Week 96. ]

Measure Type Secondary
Measure Title Number of Participants With Virologic Failure Showing Treatment Emergent Resistance Through Week 96
Measure Description Virologic failure participants defined as participants who were never suppressed (HIV RNA < 400 c/mL) and on study through Week 48, or who rebounded to HIV RNA ≥ 400 c/mL, and those who discontinued due to insufficient viral load response using CVR (NC=F). IAS-USA=International AIDS Society-United States of America, PI=protease inhibitor, RTI=reverse transcription inhibitor, TAMS=Thymidine Analogue-Associated Mutations, NRTI=non-nucleotide reverse transcriptase inhibitor, M184/V= Methionine-to-valine mutation at position 184 (in reverse transcription [RT] gene), FC=fold change
Time Frame Baseline (Day 1) and Week 96.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Resistance analysis are based on randomized population. 2 subjects with baseline phenotypic resistance to ATV/RTV are excluded. Paired baseline and on-study HIV samples tested for genotypic resistance and phenotypic resistance. "n" signifies the number of participants evaluable for each parameter.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  438     443  
Number of Participants With Virologic Failure Showing Treatment Emergent Resistance Through Week 96  
[units: Participants]
   
Virologic Failure, Week 96 (HIV RNA >= 400 c/mL)     28     29  
Paired Genotypes (n = 28, 29)     26     26  
Paired Phenotypes (n= 28, 29)     25     23  
IAS-USA major PI substitutions (n = 26, 26)     1     0  
IAS-USA minor PI substitutions (n = 26, 26)     1     1  
PI polymorphisms without IAS-USA (n=26, 26)     11     14  
PI phenotypic resistance (ATV/RTV FC >5.2 (25, 23)     1     0  
PI phenotypic resistance (LPV/RTV FC>9 (25,23)     0     1  
PI phenotypic resistance (Other PIs [25, 23])     3     6  
NRTI substitutions (TAMS [26, 26])     1     3  
NRTI substitutions (M184I/V [26, 26])     5     7  
RTI phenotypic resistance (FC [n = 25, 23])     5     5  
RTI phenotypic resistance (TDF [n = 25, 23])     0     2  
RTI phenotypic resistance (Other NRTI [n =25, 23])     5     6  

No statistical analysis provided for Number of Participants With Virologic Failure Showing Treatment Emergent Resistance Through Week 96



72.  Secondary:   Mean Change From Baseline in Trunk-to-limb Fat Ratio Measured by DEXA at Week 48   [ Time Frame: DEXA scans were taken at Baseline (Day 1) and at Weeks 48. ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Trunk-to-limb Fat Ratio Measured by DEXA at Week 48
Measure Description Mean changes from baseline in trunk-to-limb fat ratio as measured by DEXA, an x-ray scan used to measure bone mineral density. Clinical improvement was associated with a decrease in values.
Time Frame DEXA scans were taken at Baseline (Day 1) and at Weeks 48.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As-treated participants (with values for this parameter)in the lipodystrophy substudy who participated in the substudy and signed the informed consent for the substudy.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  118     81  
Mean Change From Baseline in Trunk-to-limb Fat Ratio Measured by DEXA at Week 48  
[units: Ratio]
Mean ± Standard Error
  0.04  ± 0.013     -0.02  ± 0.014  

No statistical analysis provided for Mean Change From Baseline in Trunk-to-limb Fat Ratio Measured by DEXA at Week 48



73.  Secondary:   Mean Percent Changes From Baseline in Limb, Trunk and Total Body Fat Measured by DEXA at Week 48   [ Time Frame: DEXA scans were performed at baseline (within 30 days of starting study treatment), and at Weeks 48. ]

Measure Type Secondary
Measure Title Mean Percent Changes From Baseline in Limb, Trunk and Total Body Fat Measured by DEXA at Week 48
Measure Description The mean percent change from baseline in limb, trunk and total body fat was measured by DEXA. Limb fat: a physical sign of lipoatrophy, clinical improvement in limb fat is associated with a decrease in values. Trunk fat: a physical sign of lipohypertrophy, clinical improvement in trunk fat is associated with a decrease in values. Total body fat: association of many factors like trunk fat, limb fat, weight etc. Clinical improvement in total body fat cannot be predicted based solely an increase or decrease of these values.
Time Frame DEXA scans were performed at baseline (within 30 days of starting study treatment), and at Weeks 48.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  118     82  
Mean Percent Changes From Baseline in Limb, Trunk and Total Body Fat Measured by DEXA at Week 48  
[units: Percentage]
Mean ( 95% Confidence Interval )
   
Trunk Fat     26  
  ( 18.9 to 34.5 )  
  16  
  ( 9.4 to 22.2 )  
Limb Fat     22  
  ( 15.7 to 28.9 )  
  17  
  ( 11.2 to 23.1 )  
Total Body Fat     23  
  ( 16.7 to 29.9 )  
  15  
  ( 9.8 to 21.1 )  

No statistical analysis provided for Mean Percent Changes From Baseline in Limb, Trunk and Total Body Fat Measured by DEXA at Week 48



74.  Secondary:   Mean Percent Changes From Baseline in Limb, Trunk and Total Body Fat Measured by DEXA at Week 96   [ Time Frame: Baseline (Day 1) and Week 96. ]

Measure Type Secondary
Measure Title Mean Percent Changes From Baseline in Limb, Trunk and Total Body Fat Measured by DEXA at Week 96
Measure Description The mean percent change from baseline in limb, trunk and total body fat was measured by DEXA. Limb fat: a physical sign of lipoatrophy, clinical improvement in limb fat is associated with a decrease in values. Trunk fat: physical sign of lipohypertrophy, clinical improvement in trunk fat is associated with a decrease in values. Total body fat: association of many factors like trunk fat, limb fat, weight etc. Clinical improvement in total body fat cannot be predicted based solely an increase or decrease of these values.
Time Frame Baseline (Day 1) and Week 96.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  106     71  
Mean Percent Changes From Baseline in Limb, Trunk and Total Body Fat Measured by DEXA at Week 96  
[units: Percentage]
Mean ( 95% Confidence Interval )
   
Trunk Fat     34  
  ( 23.9 to 44.8 )  
  16  
  ( 8.0 to 24.0 )  
Limb Fat     27  
  ( 18.7 to 36.3 )  
  15  
  ( 8.3 to 22.6 )  
Total Body Fat     29  
  ( 20.5 to 38.3 )  
  15  
  ( 8.0 to 22.2 )  

No statistical analysis provided for Mean Percent Changes From Baseline in Limb, Trunk and Total Body Fat Measured by DEXA at Week 96



75.  Secondary:   Median Changes From Baseline at Week 96 in VAT-to-TAT, VAT-to-SAT and, Trunk-to-limb Fat Ratio Measured by Computed Tomography (CT)/DEXA   [ Time Frame: Baseline (Day 1) and Week 96. ]

Measure Type Secondary
Measure Title Median Changes From Baseline at Week 96 in VAT-to-TAT, VAT-to-SAT and, Trunk-to-limb Fat Ratio Measured by Computed Tomography (CT)/DEXA
Measure Description No text entered.
Time Frame Baseline (Day 1) and Week 96.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  125     99  
Median Changes From Baseline at Week 96 in VAT-to-TAT, VAT-to-SAT and, Trunk-to-limb Fat Ratio Measured by Computed Tomography (CT)/DEXA  
[units: Ratio]
Mean ( 95% Confidence Interval )
   
VAT-to-TAT Ratio (n = 95,68)     -0.04  
  ( -0.06 to -0.02 )  
  -0.02  
  ( -0.04 to 0.00 )  
VAT-to-SAT Ratio (n = 95, 68)     -0.22  
  ( -0.41 to -0.04 )  
  -0.09  
  ( -0.18 to 0.00 )  
Trunk-to-Limb Fat Ratio (n = 106, 71)     0.05  
  ( 0.02 to 0.08 )  
  0.00  
  ( -0.03 to 0.03 )  

No statistical analysis provided for Median Changes From Baseline at Week 96 in VAT-to-TAT, VAT-to-SAT and, Trunk-to-limb Fat Ratio Measured by Computed Tomography (CT)/DEXA



76.  Secondary:   Mean Percent Changes From Baseline in Bone Mineral Density (BMD) Measured by DEXA at Week 48   [ Time Frame: DEXA scans were taken at Baseline (Day 1) and Week 48. ]

Measure Type Secondary
Measure Title Mean Percent Changes From Baseline in Bone Mineral Density (BMD) Measured by DEXA at Week 48
Measure Description Mean percent change from baseline in BMD of arms, legs, trunk and total body was measured using DEXA, an X-ray scan technique.
Time Frame DEXA scans were taken at Baseline (Day 1) and Week 48.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  118     82  
Mean Percent Changes From Baseline in Bone Mineral Density (BMD) Measured by DEXA at Week 48  
[units: grams/ centimeters ^2 (g/cm^2)]
Mean ( 95% Confidence Interval )
   
Bone Mineral Density of Both Arms     -1  
  ( -1.9 to -0.4 )  
  -1  
  ( -2.1 to -0.4 )  
Bone Mineral Density of Both Legs     -2  
  ( -2.0 to -1.1 )  
  -2  
  ( -2.4 to -1.4 )  
Bone Mineral Density of Trunk     -4  
  ( -4.3 to -3.0 )  
  -4  
  ( -5.2 to -3.4 )  
Bone Mineral Density of Total Body     -2  
  ( -2.7 to -1.7 )  
  -3  
  ( -3.1 to -2.1 )  

No statistical analysis provided for Mean Percent Changes From Baseline in Bone Mineral Density (BMD) Measured by DEXA at Week 48



77.  Secondary:   Mean Percent Changes From Baseline in BMD Measured by DEXA at Week 96   [ Time Frame: Baseline (Day 1) and Week 96 ]

Measure Type Secondary
Measure Title Mean Percent Changes From Baseline in BMD Measured by DEXA at Week 96
Measure Description Mean percent change from baseline in BMD of arms, legs, trunk and total body was measured using DEXA, an X-ray scan technique.
Time Frame Baseline (Day 1) and Week 96  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As-treated participants in the lipodystrophy substudy who participated in the substudy and signed the informed consent for the substudy.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  106     70  
Mean Percent Changes From Baseline in BMD Measured by DEXA at Week 96  
[units: g/cm^2]
Mean ( 95% Confidence Interval )
   
Bone Mineral Density of Both Arms     -1  
  ( -2.3 to -0.5 )  
  -2  
  ( -3.2 to -1.2 )  
Bone Mineral Density of Both Legs     -2  
  ( -2.7 to -1.1 )  
  -3  
  ( -3.4 to -1.9 )  
Bone Mineral Density of Trunk     -3  
  ( -3.7 to -1.9 )  
  -5  
  ( -5.7 to -3.5 )  
Bone Mineral Density of Total Body     -3  
  ( -3.4 to -1.9 )  
  -4  
  ( -4.5 to -2.9 )  

No statistical analysis provided for Mean Percent Changes From Baseline in BMD Measured by DEXA at Week 96



78.  Secondary:   Mean Change From Baseline in Body Weight at Week 96   [ Time Frame: Baseline (Day 1) and Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Body Weight at Week 96
Measure Description Mean change from baseline in weight at Week 96
Time Frame Baseline (Day 1) and Week 96  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety analyses of the treatment period are based on treated population with values for this parameter.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  361     338  
Mean Change From Baseline in Body Weight at Week 96  
[units: kg]
Mean ± Standard Error
  5  ± 0.4     3  ± 0.3  

No statistical analysis provided for Mean Change From Baseline in Body Weight at Week 96



79.  Secondary:   Mean Change From Baseline in Body Weight at Week 48   [ Time Frame: Baseline (Day 1) and Week 48 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Body Weight at Week 48
Measure Description Mean change from baseline in body weight at Week 48 was determined.
Time Frame Baseline (Day 1) and Week 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy, and who had values for this parameter.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  118     85  
Mean Change From Baseline in Body Weight at Week 48  
[units: kg]
Mean ± Standard Error
  4  ± 0.5     3  ± 0.7  

No statistical analysis provided for Mean Change From Baseline in Body Weight at Week 48



80.  Secondary:   Mean Change From Baseline in BMI at Week 96   [ Time Frame: Baseline (Day 1) and Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in BMI at Week 96
Measure Description No text entered.
Time Frame Baseline (Day 1) and Week 96  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety analyses of the treatment period are based on treated population with values for this parameter.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  359     338  
Mean Change From Baseline in BMI at Week 96  
[units: kg/m^2]
Mean ± Standard Error
  1.6  ± 0.13     1.0  ± 0.11  

No statistical analysis provided for Mean Change From Baseline in BMI at Week 96



81.  Secondary:   Mean Change From Baseline in Waist Circumference at Week 96   [ Time Frame: Baseline (Day 1) and Week 96. ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Waist Circumference at Week 96
Measure Description Mean change From baseline in waist circumference at Week 96 was determined.
Time Frame Baseline (Day 1) and Week 96.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy, and who had values for this parameter.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  100     71  
Mean Change From Baseline in Waist Circumference at Week 96  
[units: cm]
Mean ± Standard Error
  6  ± 0.8     2  ± 0.8  

No statistical analysis provided for Mean Change From Baseline in Waist Circumference at Week 96



82.  Secondary:   Mean Change From Baseline in Waist Circumference at Week 48   [ Time Frame: Baseline (Day 1) and Week 48 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Waist Circumference at Week 48
Measure Description Mean change from baseline in waist circumference at Week 48 was determined.
Time Frame Baseline (Day 1) and Week 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy, and who had values for this parameter.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  109     77  
Mean Change From Baseline in Waist Circumference at Week 48  
[units: cm]
Mean ± Standard Error
  4  ± 0.6     2  ± 0.7  

No statistical analysis provided for Mean Change From Baseline in Waist Circumference at Week 48



83.  Secondary:   Mean Change From Baseline in Waist-to-hip-ratio at Week 96   [ Time Frame: Baseline (Day 1) and Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Waist-to-hip-ratio at Week 96
Measure Description Mean change from baseline in waist-to-hip-ratio at Week 96 was determined.
Time Frame Baseline (Day 1) and Week 96  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy, and who had values for this parameter.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  99     71  
Mean Change From Baseline in Waist-to-hip-ratio at Week 96  
[units: ratio]
Mean ± Standard Error
  0.02  ± 0.006     0.01  ± 0.08  

No statistical analysis provided for Mean Change From Baseline in Waist-to-hip-ratio at Week 96



84.  Secondary:   Mean Change From Baseline in BMI at Week 48   [ Time Frame: Baseline (Day 1) and Week 48. ]

Measure Type Secondary
Measure Title Mean Change From Baseline in BMI at Week 48
Measure Description Mean change from baseline in BMI at Week 48 was determined.
Time Frame Baseline (Day 1) and Week 48.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy, and who had values for this parameter.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  118     85  
Mean Change From Baseline in BMI at Week 48  
[units: kg/m^2]
Mean ± Standard Error
  1.5  ± 0.19     1.1  ± 0.23  

No statistical analysis provided for Mean Change From Baseline in BMI at Week 48



85.  Secondary:   Mean Change From Baseline in Waist-to-hip-ratio at Week 48   [ Time Frame: Baseline (Day 1) and Week 48 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Waist-to-hip-ratio at Week 48
Measure Description Mean change from baseline in waist-to-hip-ratio at Week 48 was determined.
Time Frame Baseline (Day 1) and Week 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy, and who had values for this parameter.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  108     77  
Mean Change From Baseline in Waist-to-hip-ratio at Week 48  
[units: ratio]
Mean ± Standard Error
  0.02  ± 0.008     0.01  ± 0.008  

No statistical analysis provided for Mean Change From Baseline in Waist-to-hip-ratio at Week 48



86.  Secondary:   Percentage of Participants With Lipoatrophy at Week 96   [ Time Frame: Baseline (Day 1) and Week 96 ]

Measure Type Secondary
Measure Title Percentage of Participants With Lipoatrophy at Week 96
Measure Description Lipoatrophy, redistribution of body fat was defined as >= 20% decrease in limb fat. The percentage of participants with lipoatrophy from baseline was determined.
Time Frame Baseline (Day 1) and Week 96  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy, and who had values for this parameter.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  106     70  
Percentage of Participants With Lipoatrophy at Week 96  
[units: percentage of participants]
  5     7  

No statistical analysis provided for Percentage of Participants With Lipoatrophy at Week 96



87.  Secondary:   Mean Changes From Baseline in Body Weight at Week 96   [ Time Frame: Physical examination was performed at Baseline (Day 1) and Weeks 48 and 96. ]

Measure Type Secondary
Measure Title Mean Changes From Baseline in Body Weight at Week 96
Measure Description Mean change in body weight from baseline was determined.
Time Frame Physical examination was performed at Baseline (Day 1) and Weeks 48 and 96.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy, and who had values for this parameter.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  110     78  
Mean Changes From Baseline in Body Weight at Week 96  
[units: kg]
Mean ± Standard Error
  6  ± 0.7     3  ± 0.8  

No statistical analysis provided for Mean Changes From Baseline in Body Weight at Week 96



88.  Secondary:   Mean Change From Baseline in BMI at Week 96   [ Time Frame: Baseline (Day 1) and Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in BMI at Week 96
Measure Description Mean change From baseline in BMI at Week 96 was determined.
Time Frame Baseline (Day 1) and Week 96  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy, and with values for this parameter.

Reporting Groups
  Description
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.

Measured Values
    ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD     LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD  
Number of Participants Analyzed  
[units: participants]
  110     78  
Mean Change From Baseline in BMI at Week 96  
[units: kg/m^2]
Mean ± Standard Error
  2.0  ± 0.26     1.2  ± 0.28  

No statistical analysis provided for Mean Change From Baseline in BMI at Week 96




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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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