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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

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ClinicalTrials.gov Identifier: NCT00272779
Recruitment Status : Completed
First Posted : January 9, 2006
Results First Posted : May 9, 2011
Last Update Posted : May 9, 2011
Sponsor:
Information provided by:
Bristol-Myers Squibb

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV Infections
Interventions Drug: ATV
Drug: RTV
Drug: Tenofovi-Emtricitabine (TDF/FTC) tablet
Drug: LPV
Enrollment 1057
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title 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
Hide Arm/Group Description 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. 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.
Period Title: Baseline Through Week 48
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
Reason Not Completed
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 Title: Baseline Through Week 96
Started 440 [1] 443 [2]
RECEIVED ANY TREATMENT 441 [3] 437 [4]
Completed 301 307
Not Completed 139 136
Reason Not Completed
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
Arm/Group Title 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
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 440 443 883
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 440 participants 443 participants 883 participants
36  (9.1) 37  (10.0) 36  (9.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 440 participants 443 participants 883 participants
Female
138
  31.4%
139
  31.4%
277
  31.4%
Male
302
  68.6%
304
  68.6%
606
  68.6%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 440 participants 443 participants 883 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
1.Primary Outcome
Title Number of Participants With Human-immunodeficiency Virus- Ribonucleic Acid (HIV-RNA) < 50 Copies (c)/mL at Week 48
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 440 443
Measure Type: Number
Unit of Measure: Participants
343 338
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 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
Comments 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
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Assuming 70% response rate (70% of participants remain on treatment for 48 wks and HIV RNA <50 copies/mL) on both regimens, sample size of 882 randomized participants (441/regimen) provided 90% power to demonstrate ATV/RTV is non-inferior to LPV/RTV
Method Cochran-Mantel-Haenszel
Comments 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%.
Method of Estimation Estimation Parameter Difference Estimate
Estimated Value 1.7
Confidence Interval (2-Sided) 95%
-3.8 to 7.1
Estimation Comments [Not Specified]
2.Primary Outcome
Title Maximum Plasma Concentration (Cmax) of ATV/RTV and LPV/RTV in the Presence of an Antiretroviral (ARV) Regimen Including TDF at Week 4
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who completed the intensive pharmacokinetic (PK) study.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 18 21
Geometric Mean (Full Range)
Unit of Measure: nanogram(ng)/mL
2897
(837.0 to 5610)
10654
(5658 to 31316)
3.Primary Outcome
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
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who completed the intensive PK study.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 18 21
Geometric Mean (Full Range)
Unit of Measure: ng*h/mL
28605
(9908 to 58872)
90945
(43260 to 302989)
4.Primary Outcome
Title Minimum Plasma Concentration (Cmin) of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who completed the intensive PK study.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 18 21
Geometric Mean (Full Range)
Unit of Measure: ng/mL
526.4
(130.0 to 1350)
5944
(1555 to 22739)
5.Primary Outcome
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
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who completed the intensive PK study.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 18 21
Median (Full Range)
Unit of Measure: Hr
3.00
(1.50 to 24.00)
4.00
(0.00 to 12.00)
6.Primary Outcome
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
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who completed the intensive PK study.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 17 12
Mean (Standard Deviation)
Unit of Measure: Hr
10.31  (3.32) 13.89  (14.48)
7.Primary Outcome
Title Protein Binding Adjusted Effective Concentration (EC-90) of ATV and LPV When Dosed With RTV at Week 4
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who completed the intensive PK study.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 17 19
Geometric Mean (Full Range)
Unit of Measure: ng/mL
19.01
(8.29 to 35.23)
162.7
(100.6 to 471.6)
8.Primary Outcome
Title Inhibitory Quotient (IQ) of ATV and LPV When Dosed With RTV at Week 4
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who completed the intensive PK study.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 17 19
Geometric Mean (Full Range)
Unit of Measure: ng/mL
27.33
(3.94 to 77.27)
35.91
(10.76 to 129.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 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
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter point estimate
Estimated Value 0.761
Confidence Interval (2-Sided) 90%
0.507 to 1.142
Estimation Comments 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 Outcome
Title Cmax of RTV at Week 4
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who completed the intensive PK study.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 18 21
Geometric Mean (Full Range)
Unit of Measure: ng/mL
959.8
(139.0 to 2900)
657.4
(193.8 to 1814)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 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
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter point estimate
Estimated Value 1.460
Confidence Interval (2-Sided) 90%
1.005 to 2.121
Estimation Comments 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 Outcome
Title AUC (0-24) of RTV at Week 4
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who completed the intensive PK study.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 18 21
Geometric Mean (Full Range)
Unit of Measure: ng*h/mL
6724
(1371 to 23854)
8011
(2815 to 19929)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 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
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter point estimate
Estimated Value 0.839
Confidence Interval (2-Sided) 90%
0.612 to 1.151
Estimation Comments 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 Outcome
Title Cmin of RTV at Week 4
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who completed the intensive PK study.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 18 21
Geometric Mean (Full Range)
Unit of Measure: ng/mL
50.52
(14.50 to 298.0)
179.0
(42.82 to 763.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 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
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter point estimate
Estimated Value 0.282
Confidence Interval (2-Sided) 90%
0.181 to 0.439
Estimation Comments 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 Outcome
Title Cmax of Tenofovir at Week 4
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who completed the intensive PK study.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 17 20
Geometric Mean (Full Range)
Unit of Measure: ng/mL
352.0
(104.8 to 641.8)
380.7
(118.0 to 1801)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 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
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter point estimate
Estimated Value 0.925
Confidence Interval (2-Sided) 90%
0.699 to 1.223
Estimation Comments 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 Outcome
Title Cmin of Tenofovir at Week 4
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who completed the intensive PK study.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 17 20
Geometric Mean (Full Range)
Unit of Measure: ng/mL
72.46
(21.08 to 114.7)
84.98
(44.27 to 757.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 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
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter point estimate
Estimated Value 0.853
Confidence Interval (2-Sided) 90%
0.626 to 1.161
Estimation Comments 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 Outcome
Title AUC (TAU) of Tenofovir at Week 4
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who completed the intensive PK study.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 17 20
Geometric Mean (Full Range)
Unit of Measure: ng*h/mL
3272
(1678 to 5486)
3675
(2240 to 25385)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 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
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter point estimate
Estimated Value 0.890
Confidence Interval (2-Sided) 90%
0.689 to 1.151
Estimation Comments 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 Outcome
Title Mean Change From Baseline in Trunk-to-Limb Fat Ratio as Measured by Dual Energy X-ray Absorptiometry (DEXA) at Week 96
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
As-treated participants in the lipodystrophy substudy who participated and signed the informed consent for the substudy.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 106 70
Mean (Standard Error)
Unit of Measure: Ratio
0.05  (0.015) 0.00  (0.015)
16.Primary Outcome
Title Number of Participants With Single Nucleotide Polymorphisms (SNPs) Included in Genotype-Phenotype Analysis
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title All Participants With Pharmacogenetic Blood Samples
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 199
Measure Type: Number
Unit of Measure: 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
17.Primary Outcome
Title Mean Change From Baseline in Fasting Non-High Density Lipoprotein (HDL) Cholesterol Associated With RETN_097
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 99 100
Mean (Standard Error)
Unit of Measure: mg/dL
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)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 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
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0847
Comments 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.
Method linear mixed effect model
Comments 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)
18.Primary Outcome
Title Mean Change From Baseline in Fasting Triglycerides Associated With RETN_097
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 99 100
Mean (Standard Error)
Unit of Measure: mg/dL
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)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 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
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0058
Comments 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.
Method linear mixed effect model
Comments 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)
19.Primary Outcome
Title Mean Change From Baseline in Fasting Triglycerides Associated With RETN_2265
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 99 100
Mean (Standard Error)
Unit of Measure: mg/dL
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)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 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
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0058
Comments 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.
Method linear mixed effect model
Comments 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)
20.Primary Outcome
Title Mean Change From Baseline in Fasting Triglycerides Associated With RETN_598
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 99 100
Mean (Standard Error)
Unit of Measure: mg/dL
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)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 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
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0253
Comments 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.
Method linear mixed effect model
Comments 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)
21.Primary Outcome
Title Mean Change From Baseline in Fasting Triglycerides Associated With APOE_C130R
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 99 100
Mean (Standard Error)
Unit of Measure: mg/dL
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)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 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
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1173
Comments 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.
Method linear mixed effect model
Comments 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)
22.Primary Outcome
Title Mean Change From Baseline in Fasting Triglycerides Associated With RETN_734
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 99 100
Mean (Standard Error)
Unit of Measure: mg/dL
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)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 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
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1173
Comments 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.
Method linear mixed effect model
Comments 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)
23.Primary Outcome
Title Mean Change From Baseline in Fasting Plasminogen Activator Inhibitor (PAI)-1 Associated With APOE_R176C
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 99 100
Mean (Standard Error)
Unit of Measure: ng/dL
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)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 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
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1847
Comments 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.
Method linear mixed effect model
Comments 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)
24.Primary Outcome
Title Mean Change From Baseline in Fasting Tumor Necrosis Factor (TNF)-Alpha Associated With IL6_5309
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 99 100
Mean (Standard Error)
Unit of Measure: pg/mL
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)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 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
Comments 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
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1833
Comments 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.
Method linear mixed effect model
Comments 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)
25.Primary Outcome
Title Mean Change From Baseline in Fasting Tumor Necrosis Factor (TNF)-Alpha Asssociated With RS11030679
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 99 100
Mean (Standard Error)
Unit of Measure: pg/mL
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)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 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
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1833
Comments 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.
Method linear mixed effect model
Comments 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)
26.Primary Outcome
Title Mean Change From Baseline in Subcutaneous Adipose Tissue (SAT)-To-Trunk Adipose Tissue (TAT) Ratio Associated With CCDC122_5980
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 99 100
Mean (Standard Error)
Unit of Measure: cm^2
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)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 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
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1694
Comments 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.
Method linear mixed effect model
Comments 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)
27.Primary Outcome
Title Mean Change From Baseline in Visceral Adipose Tissue (VAT) Associated With BRUNOL_1842
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 99 100
Mean (Standard Error)
Unit of Measure: cm^2
VAT: BRUNOL_1842 WT 23.45  (6.55) 10.38  (7.13)
VAT: BRUNOL_1842 MAC -3.20  (6.18) -1.76  (9.32)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 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
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1335
Comments 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.
Method linear mixed effect model
Comments 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)
28.Primary Outcome
Title Mean Change From Baseline in VAT Associated With RETN_730
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 99 100
Mean (Standard Error)
Unit of Measure: cm^2
VAT: RETN_730 WT -2.95  (6.10) 13.69  (8.03)
VAT: RETN_730 MAC 23.29  (6.52) -1.05  (7.61)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 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
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1335
Comments 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.
Method linear mixed effect model
Comments 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)
29.Primary Outcome
Title Mean Change From Baseline in VAT-to-TAT Ratio Associated With CCDA122_5980
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 99 100
Mean (Standard Error)
Unit of Measure: cm^2
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)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 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
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1696
Comments 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.
Method linear mixed effect model
Comments 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)
30.Secondary Outcome
Title Number of Participants With HIV RNA < 400 c/mL at Week 48
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 440 443
Measure Type: Number
Unit of Measure: Participants
377 365
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 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
Comments 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).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference Estimate
Estimated Value 3.3
Confidence Interval (2-Sided) 95%
-1.5 to 8.1
Estimation Comments [Not Specified]
31.Secondary Outcome
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)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Efficacy analyses of the treatment period are based on randomized population.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 440 443
Measure Type: Number
Unit of Measure: Participants
377 363
32.Secondary Outcome
Title Reduction of log10 HIV RNA Levels From Baseline to Week 48
Hide Description Changes from baseline in log10 HIV RNA levels were calculated.
Time Frame Baseline (Day 1) and Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All treated participants with data for this parameter.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 397 379
Mean (Standard Error)
Unit of Measure: c/mL
-3.09  (0.042) -3.13  (0.037)
33.Secondary Outcome
Title Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 48
Hide Description Mean change from baseline in CD4 cell counts was determined.
Time Frame Baseline (Day 1) and Week 48.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All treated participants with data for this parameter.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 370 363
Mean (Standard Error)
Unit of Measure: c/mm^3
203  (7.1) 219  (7.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 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
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method 95% CI comparison of difference
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference Estimate
Estimated Value -16.4
Confidence Interval (2-Sided) 95%
-35.9 to 3.1
Estimation Comments [Not Specified]
34.Secondary Outcome
Title Treatment Emergent Resistance in Isolates From Participants With Virologic Failure at Week 48
Hide 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
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Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 440 443
Measure Type: Number
Unit of Measure: 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
35.Secondary Outcome
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
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety analyses of the treatment period are based on treated population.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 441 437
Measure Type: Number
Unit of Measure: Participants
Deaths 6 6
Other SAEs 51 42
AEs 400 399
AEs leading to discontinuation 11 15
36.Secondary Outcome
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)
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 441 437
Measure Type: Number
Unit of Measure: 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
37.Secondary Outcome
Title Number of Participants With Laboratory Abnormalities in Serum Enzymes Levels Through Week 48
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 441 437
Measure Type: Number
Unit of Measure: Participants
CPK (n = 435, 430) 22 20
Lipase (n = 435, 430) 6 6
38.Secondary Outcome
Title Number of Participants With Laboratory Abnormalities in Liver Function Test Through Week 48
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 441 437
Measure Type: Number
Unit of Measure: 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
39.Secondary Outcome
Title Number of Participants With Laboratory Abnormalities in Renal Function Test Through Week 48
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 441 437
Measure Type: Number
Unit of Measure: 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
40.Secondary Outcome
Title Number of Participants With Laboratory Abnormalities in Electrolytes Through Week 48
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 441 437
Measure Type: Number
Unit of Measure: 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
41.Secondary Outcome
Title Number of Participants With Laboratory Abnormalities in Urinalysis Through Week 48
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 441 437
Measure Type: Number
Unit of Measure: Participants
Glycosuria (n = 434, 431) 4 3
Proteinuria (n = 434, 431) 3 1
42.Secondary Outcome
Title Number of Participants With Laboratory Abnormalities in Fasting Lipids Through Week 48
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 441 437
Measure Type: Number
Unit of Measure: Participants
Total Cholesterol (n = 434, 428) 30 77
Triglycerides (n = 434, 428) 2 15
43.Secondary Outcome
Title Number of Participants With Laboratory Abnormalities in Fasting Glucose Through Week 48
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 441 437
Measure Type: Number
Unit of Measure: Participants
Hyperglycemia (n = 434, 428) 1 1
Hypoglycemia (n = 434, 428) 0 0
44.Secondary Outcome
Title Mean Change in Weight From Baseline at Week 48
Hide Description Mean change in body weight from baseline was determined.
Time Frame Baseline (Day 1) and Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety analyses of the treatment period are based on treated population, who had values for this parameter.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 395 370
Mean (Standard Error)
Unit of Measure: kg
4.0  (0.3) 2.0  (0.3)
45.Secondary Outcome
Title Mean Change in Body Mass Index (BMI) in Participants at Week 48
Hide Description Mean change in BMI from baseline at Week 48 was determined.
Time Frame Baseline (Day 1) and Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety analyses of the treatment period are based on treated population, who had values for this parameter.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 393 370
Mean (Standard Error)
Unit of Measure: kg/m^2
1.3  (0.10) 0.8  (0.10)
46.Secondary Outcome
Title Mean Change in Fasting Lipid at Week 48
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety analyses of the treatment period are based on treated population.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 441 437
Mean (Standard Error)
Unit of Measure: milligrams/deciliter (mg/dL)
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)
47.Secondary Outcome
Title Mean Change in Fasting Glucose at Week 48
Hide Description Mean change from baseline in fasting glucose at Week 48.
Time Frame Baseline (Day 1) and Week 48.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety analyses of the treatment period are based on treated population with values for this parameter.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 383 363
Mean (Standard Error)
Unit of Measure: mg/dL
2  (0.6) 0  (1.3)
48.Secondary Outcome
Title Mean Change in Fasting Insulin at Week 48
Hide Description Mean change from baseline in fasting insulin at Week 48.
Time Frame Baseline (Day 1) and Week 48.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety analyses of the treatment period are based on treated population with values for this parameter.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 371 352
Mean (Standard Error)
Unit of Measure: micro units (µU)/mL
2.5  (0.52) 0.2  (0.38)
49.Secondary Outcome
Title Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey - Human Immunodeficiency Virus (MOS-HIV) at Week 24
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 347 351
Mean (Standard Error)
Unit of Measure: Units on Scale
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)
50.Secondary Outcome
Title Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey - Human Immunodeficiency Virus (MOS-HIV) at Week 48
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 347 351
Mean (Standard Error)
Unit of Measure: Units on Scale
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)
51.Secondary Outcome
Title Mean Change From Baseline (BL) in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 4 (IBS-QoL)
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 343 349
Mean (Standard Error)
Unit of Measure: Units on Scale
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)
52.Secondary Outcome
Title Mean Change From Baseline in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 12 (IBS-QoL)
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 343 349
Mean (Standard Error)
Unit of Measure: Units on Scale
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)
53.Secondary Outcome
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)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 343 349
Mean (Standard Error)
Unit of Measure: Units on a scale
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)
54.Secondary Outcome
Title Number of Participants Who Adhered to Regimen as Measured by Multicenter AIDS Cohort Study Adherence Questionnaire (MACS) at Week 48
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The 'n' is signifying those participants who were evaluated for this measure at the timepoint for each group respectively.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 401 378
Measure Type: Number
Unit of Measure: Participants
330 316
55.Secondary Outcome
Title Number of Participants With HIV RNA < 50 c/mL) at Week 96
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 440 443
Measure Type: Number
Unit of Measure: Participants
327 302
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 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
Comments 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
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments Assuming 70% response rate (70% of participants remain on treatment for 96 wks and HIV RNA <50 copies/mL) on both regimens, sample size of 882 randomized participants (441/regimen) provided 90% power to demonstrate ATV/RTV is non-inferior to LPV/RTV
Method Cochran-Mantel-Haenszel
Comments 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%.
Method of Estimation Estimation Parameter Difference Estimate
Estimated Value 6.1
Confidence Interval (2-Sided) 95%
0.3 to 12.0
Estimation Comments [Not Specified]
56.Secondary Outcome
Title Number of Participants With HIV RNA < 400 c/mL) at Week 96
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 440 443
Measure Type: Number
Unit of Measure: Participants
350 330
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 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
Comments 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).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference Estimate
Estimated Value 5.1
Confidence Interval (2-Sided) 95%
-0.4 to 10.6
Estimation Comments [Not Specified]
57.Secondary Outcome
Title Reduction of log10 HIV RNA Levels From Baseline at Week 96
Hide Description Changes from baseline in log10 HIV RNA levels were calculated.
Time Frame Baseline (Day 1) and Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 360 340
Mean (Standard Error)
Unit of Measure: c/mL
-3.21  (0.034) -3.19  (0.036)
58.Secondary Outcome
Title Mean Change From Baseline in CD4 Cell Count at Week 96
Hide Description Mean change from baseline in CD4 count among treated participants was determined.
Time Frame Baseline (Day 1) and Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Efficacy analyses of the treatment period are based on as-randomized population with values for this parameter.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 336 317
Mean (Standard Error)
Unit of Measure: cells/mm^3
268  (7.6) 290  (8.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 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
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method 95% CI comparison of difference
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference Estimate
Estimated Value -21.2
Confidence Interval (2-Sided) 95%
-43.3 to 0.9
Estimation Comments [Not Specified]
59.Secondary Outcome
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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety analyses of the treatment period are based on treated population.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 441 437
Measure Type: Number
Unit of Measure: Participants
Deaths 6 6
Serious Adverse Events (SAEs) 63 50
Adverse Events (AEs) leading to discontinuation 13 22
60.Secondary Outcome
Title Mean Changes in Fasting Lipids at Week 96
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety analyses of the treatment period are based on treated population.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 441 437
Mean (Standard Error)
Unit of Measure: mg/dL
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)
61.Secondary Outcome
Title Mean Changes in Fasting Glucose at Week 96
Hide Description Mean change from baseline in fasting glucose at Week 96 was determined.
Time Frame Baseline (Day 1) and Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety analyses of the treatment period are based on treated population with values for this parameter.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 355 330
Mean (Standard Error)
Unit of Measure: mg/dL
4.0  (1.2) 1.0  (1.4)
62.Secondary Outcome
Title Mean Changes in Fasting Insulin at Week 96
Hide Description Mean change from baseline in fasting insulin at Week 96.
Time Frame Baseline (Day 1) and Week 96.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety analyses of the treatment period are based on treated population with values for this parameter.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 349 324
Mean (Standard Error)
Unit of Measure: µU/mL
0.1  (0.47) -0.8  (0.43)
63.Secondary Outcome
Title Number of Participants With Laboratory Abnormalities in Hematology: Hemoglobin, Hematocrit, Platelet Count, INR, Neutrophils, PT and WBC Through Week 96
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 441 437
Measure Type: Number
Unit of Measure: 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
64.Secondary Outcome
Title Number of Participants With Laboratory Abnormalities in Serum Enzyme Levels Through Week 96
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety analyses of the treatment period are based on treated population.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 441 437
Measure Type: Number
Unit of Measure: Participants
CPK (n=435, 430) 34 28
Lipase (n=435, 430) 9 9
65.Secondary Outcome
Title Number of Participants With Laboratory Abnormalities in Liver Function Test Through Week 96
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 441 437
Measure Type: Number
Unit of Measure: 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
66.Secondary Outcome
Title Number of Participants With Laboratory Abnormalities in Renal Function Test Through Week 96
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety analyses of the treatment period are based on treated population.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 441 437
Measure Type: Number
Unit of Measure: 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
67.Secondary Outcome
Title Number of Participants With Laboratory Abnormalities in Electrolytes Level Through Week 96
Hide 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety analyses of the treatment period are based on treated population.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 441 437
Measure Type: Number
Unit of Measure: 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
68.Secondary Outcome
Title Number of Participants With Laboratory Abnormalities in Fasting Lipids Level Through Week 96
Hide 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.