Atazanavir (BMS-232632) in Combination With Ritonavir or Saquinavir, and Lopinavir/Ritonavir, Each With Tenofovir and a Nucleoside in Subjects With HIV

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00035932
First received: May 6, 2002
Last updated: November 29, 2010
Last verified: November 2010
Results First Received: October 14, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: Atazanavir + ritonavir + tenofovir + nucleoside
Drug: Atazanavir + saquinavir + tenofovir + nucleoside
Drug: Lopinavir/ritonavir + tenofovir + nucleoside

  Participant Flow
  Hide Participant Flow

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

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
571 human immunodeficiency virus (HIV)-infected participants were enrolled; 358 (63%) were randomized to treatment. Of the 213 not randomized, 194 did not meet eligibility criteria; other reasons include duplicate enrollment (4), accrual closed (1), noncompliance (1), serious adverse event (2), patient request (11), missing information (4).

Reporting Groups
  Description
ATV 300 mg / RTV

atazanavir (ATV) 300 mg + ritonavir (RTV) 100 mg + tenofovir (TDF) 300 mg + nucleoside of choice

ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

ATV 400 mg / SQV

ATV 400 mg + saquinavir (SQV) 1200 mg + TDF 300 mg + nucleoside of choice

ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

LPV / RTV

lopinavir (LPV)/RTV 400/100 mg + TDF 300 mg + nucleoside of choice

LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study


Participant Flow:   Overall Study
    ATV 300 mg / RTV     ATV 400 mg / SQV     LPV / RTV  
STARTED     119 [1]   110 [2]   118 [3]
Discontinued Prior to Week 48 Visit     26     29     13  
Discontinued Between Weeks 48 and 96     26     27     30  
Discontinued on or After Week 96     4     4     6  
COMPLETED     63 [4]   50 [5]   69 [6]
NOT COMPLETED     56     60     49  
Adverse Event                 10                 9                 9  
Death                 0                 0                 1  
Disease Progression / Relapse                 1                 1                 0  
Lost to Follow-up                 4                 4                 3  
Noncompliance                 6                 7                 6  
Protocol Violation While on Study                 0                 1                 2  
Withdrawal by Subject                 1                 5                 0  
Study Termination by Sponsor                 1                 0                 0  
Lack of Efficacy                 33                 33                 28  
[1] 120 randomized, 119 treated
[2] 115 randomized, 110 treated
[3] 123 randomized, 118 treated
[4] 63 remained on treatment, 0 completed at Week 96
[5] 50 remained on treatment, 0 completed at Week 96
[6] 59 remained on treatment, 10 completed at Week 96



  Baseline Characteristics
  Hide Baseline Characteristics

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

Reporting Groups
  Description
ATV 300 mg / RTV

ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice

ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

ATV 400 mg / SQV

ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice

ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

LPV / RTV

LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice

LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

Total Total of all reporting groups

Baseline Measures
    ATV 300 mg / RTV     ATV 400 mg / SQV     LPV / RTV     Total  
Number of Participants  
[units: participants]
  120     115     123     358  
Age  
[units: years]
Median ( Full Range )
  39  
  ( 24 to 71 )  
  41  
  ( 26 to 74 )  
  39  
  ( 25 to 72 )  
  40  
  ( 24 to 74 )  
Gender  
[units: participants]
       
Female     24     26     27     77  
Male     96     89     96     281  
Race/Ethnicity, Customized  
[units: participants]
       
White     75     70     71     216  
Hispanic/Latino     27     26     27     80  
Black     18     16     21     55  
Other     0     3     4     7  
Region of Enrollment  
[units: participants]
       
South America     56     55     54     165  
North America     39     38     47     124  
Europe     25     22     22     69  
Acquired Immunodeficiency Virus (AIDS)  
[units: participants]
       
Yes     33     33     36     102  
No     87     82     87     256  
Intravenous (IV) Drug Use  
[units: participants]
       
Yes     8     7     8     23  
No     112     108     115     335  
Cluster of Differentiation 4 (CD4) cell count  
[units: cells/mm^3]
Median ( Full Range )
  317  
  ( 40 to 1025 )  
  286  
  ( 42 to 1543 )  
  283  
  ( 14 to 1238 )  
  297  
  ( 14 to 1543 )  
Human Immunodeficiency Virus Ribonucleic Acid (HIV RNA)  
[units: log10 c/mL]
Median ( Full Range )
  4.44  
  ( 2.60 to 5.88 )  
  4.42  
  ( 2.60 to 5.88 )  
  4.47  
  ( 2.60 to 5.88 )  
  4.45  
  ( 2.60 to 5.88 )  



  Outcome Measures
  Hide All Outcome Measures

1.  Primary:   Mean Change From Baseline in HIV Ribonucleic Acid (RNA) at Week 24   [ Time Frame: Baseline, Week 24 ]

Measure Type Primary
Measure Title Mean Change From Baseline in HIV Ribonucleic Acid (RNA) at Week 24
Measure Description No text entered.
Time Frame Baseline, Week 24  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Randomized participants; as-randomized population (refers to the treatment regimen assigned at randomization).

Reporting Groups
  Description
ATV 300 mg / RTV

ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice

ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

ATV 400 mg / SQV

ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice

ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

LPV / RTV

LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice

LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study


Measured Values
    ATV 300 mg / RTV     ATV 400 mg / SQV     LPV / RTV  
Number of Participants Analyzed  
[units: participants]
  120     115     123  
Mean Change From Baseline in HIV Ribonucleic Acid (RNA) at Week 24  
[units: log10 c/mL]
Mean ± Standard Error
  -1.86  ± 0.11     -1.52  ± 0.13     -1.89  ± 0.11  


Statistical Analysis 1 for Mean Change From Baseline in HIV Ribonucleic Acid (RNA) at Week 24
Groups [1] ATV 300 mg / RTV vs. LPV / RTV
Non-Inferiority/Equivalence Test [2] Yes
Time-Averaged Difference [3] 0.14
97.5% Confidence Interval ( -0.09 to 0.37 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  The time-averaged difference (TAD) in the reduction of log10 HIV RNA levels from baseline through Week 24 was compared pairwise for each atazanavir regimen to the lopinavir/RTV regimen, and assessed using a two-sided 97.5% confidence interval. The primary efficacy analysis was to declare two treatment regimens similar if the upper limit of this 97.5% confidence interval for the difference (atazanavir-lopinavir/RTV) was less than 0.5 log10.
[3] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Mean Change From Baseline in HIV Ribonucleic Acid (RNA) at Week 24
Groups [1] ATV 400 mg / SQV vs. LPV / RTV
Non-Inferiority/Equivalence Test [2] Yes
Time-Averaged Difference [3] 0.31
97.5% Confidence Interval ( 0.07 to 0.55 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  The time-averaged difference (TAD) in the reduction of log10 HIV RNA levels from baseline through Week 24 was compared pairwise for each atazanavir regimen to the lopinavir/RTV regimen, and assessed using a two-sided 97.5% confidence interval. The primary efficacy analysis was to declare two treatment regimens similar if the upper limit of this 97.5% confidence interval for the difference (atazanavir-lopinavir/RTV) was less than 0.5 log10.
[3] Other relevant estimation information:
  No text entered.



2.  Primary:   Mean Change From Baseline in HIV RNA at Week 48   [ Time Frame: Baseline, Week 48 ]

Measure Type Primary
Measure Title Mean Change From Baseline in HIV RNA at Week 48
Measure Description No text entered.
Time Frame Baseline, Week 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Randomized participants; as-randomized population (refers to the treatment regimen assigned at randomization).

Reporting Groups
  Description
ATV 300 mg / RTV

ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice

ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

ATV 400 mg / SQV

ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice

ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

LPV / RTV

LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice

LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study


Measured Values
    ATV 300 mg / RTV     ATV 400 mg / SQV     LPV / RTV  
Number of Participants Analyzed  
[units: participants]
  120     115     123  
Mean Change From Baseline in HIV RNA at Week 48  
[units: log10 c/mL]
Mean ± Standard Error
  -1.93  ± 0.12     -1.55  ± 0.14     -1.87  ± 0.13  


Statistical Analysis 1 for Mean Change From Baseline in HIV RNA at Week 48
Groups [1] ATV 300 mg / RTV vs. LPV / RTV
Time-Averaged Difference [2] 0.13
97.5% Confidence Interval ( -0.12 to 0.39 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Mean Change From Baseline in HIV RNA at Week 48
Groups [1] ATV 400 mg / SQV vs. LPV / RTV
Time-Averaged Distance [2] 0.33
97.5% Confidence Interval ( 0.07 to 0.60 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant estimation information:
  No text entered.



3.  Primary:   Mean Change From Baseline in HIV RNA at Week 96   [ Time Frame: Baseline, Week 96 ]

Measure Type Primary
Measure Title Mean Change From Baseline in HIV RNA at Week 96
Measure Description No text entered.
Time Frame Baseline, Week 96  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Randomized participants while on initial regimen

Reporting Groups
  Description
ATV 300 mg / RTV

ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice

ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

LPV / RTV

LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice

LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study


Measured Values
    ATV 300 mg / RTV     LPV / RTV  
Number of Participants Analyzed  
[units: participants]
  64     65  
Mean Change From Baseline in HIV RNA at Week 96  
[units: log10 c/mL]
Mean ± Standard Error
  -2.29  ± 0.121     -2.08  ± 0.151  


Statistical Analysis 1 for Mean Change From Baseline in HIV RNA at Week 96
Groups [1] All groups
time-averaged difference [2] 0.14
97.5% Confidence Interval ( -0.13 to 0.41 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  overall
[2] Other relevant estimation information:
  ATV 300/RTV - LPV/RTV

Statistical Analysis 2 for Mean Change From Baseline in HIV RNA at Week 96
Groups [1] All groups
time-averaged difference [2] 0.11
97.5% Confidence Interval ( -0.16 to 0.38 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  last observation carried forward
[2] Other relevant estimation information:
  ATV 300/RTV - LPV/RTV



4.  Secondary:   Mean Change From Baseline in HIV RNA at Week 2   [ Time Frame: Baseline, Week 2 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in HIV RNA at Week 2
Measure Description No text entered.
Time Frame Baseline, Week 2  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated participants, as-randomized (refers to the treatment regimen assigned at randomization).

Reporting Groups
  Description
ATV 300 mg / RTV

ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice

ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

ATV 400 mg / SQV

ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice

ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

LPV / RTV

LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice

LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study


Measured Values
    ATV 300 mg / RTV     ATV 400 mg / SQV     LPV / RTV  
Number of Participants Analyzed  
[units: participants]
  120     115     123  
Mean Change From Baseline in HIV RNA at Week 2  
[units: log10 c/mL]
Mean ± Standard Error
  -1.18  ± 0.06     -1.14  ± 0.07     -1.30  ± 0.06  


Statistical Analysis 1 for Mean Change From Baseline in HIV RNA at Week 2
Groups [1] ATV 300 mg / RTV vs. LPV / RTV
Treatment Difference [2] 0.13
95% Confidence Interval ( -0.04 to 0.30 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Mean Change From Baseline in HIV RNA at Week 2
Groups [1] ATV 400 mg / SQV vs. LPV / RTV
Treatment Difference [2] 0.17
95% Confidence Interval ( -0.01 to 0.35 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant estimation information:
  No text entered.



5.  Secondary:   Participants Achieving Virologic Half Log Suppression (Limit of Quantification [LOQ] = 400 c/mL) at Week 24 (Overall and by Protease Inhibitor [PI] Sensitivity)   [ Time Frame: Baseline, Week 24 ]

Measure Type Secondary
Measure Title Participants Achieving Virologic Half Log Suppression (Limit of Quantification [LOQ] = 400 c/mL) at Week 24 (Overall and by Protease Inhibitor [PI] Sensitivity)
Measure Description Number of participants with a >=0.5 log10 decrease in HIV RNA from baseline or HIV RNA < 400 c/mL at Week 24, by their baseline phenotypic sensitivity to their randomized PI.
Time Frame Baseline, Week 24  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Number of Participants Analyzed=Randomized participants; as-randomized population (refers to the treatment regimen assigned at randomization); n=number of evaluable (overall, PI sensitive, PI resistant) participants.

Reporting Groups
  Description
ATV 300 mg / RTV

ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice

ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

ATV 400 mg / SQV

ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice

ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

LPV / RTV

LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice

LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study


Measured Values
    ATV 300 mg / RTV     ATV 400 mg / SQV     LPV / RTV  
Number of Participants Analyzed  
[units: participants]
  120     115     123  
Participants Achieving Virologic Half Log Suppression (Limit of Quantification [LOQ] = 400 c/mL) at Week 24 (Overall and by Protease Inhibitor [PI] Sensitivity)  
[units: participants]
     
Overall (n=120, 115, 123)     95     74     93  
PI Sensitive (n=88, 83, 88)     79     58     72  
PI Resistant (n=32, 30, 33)     16     15     19  

No statistical analysis provided for Participants Achieving Virologic Half Log Suppression (Limit of Quantification [LOQ] = 400 c/mL) at Week 24 (Overall and by Protease Inhibitor [PI] Sensitivity)



6.  Secondary:   Participants Achieving Virologic Half Log Suppression (LOQ = 400 c/mL) at Week 48, (Overall and by PI Sensitivity)   [ Time Frame: Baseline, Week 48 ]

Measure Type Secondary
Measure Title Participants Achieving Virologic Half Log Suppression (LOQ = 400 c/mL) at Week 48, (Overall and by PI Sensitivity)
Measure Description Number of participants with a >=0.5 log10 decrease in HIV RNA from baseline or HIV RNA < 400 c/mL at Week 48, by their baseline phenotypic sensitivity to their randomized PI.
Time Frame Baseline, Week 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Number of Participants Analyzed=Randomized participants; as-randomized population (refers to the treatment regimen assigned at randomization).n=number of evaluable (overall, PI sensitive, PI resistant) participants.

Reporting Groups
  Description
ATV 300 mg / RTV

ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice

ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

ATV 400 mg / SQV

ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice

ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

LPV / RTV

LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice

LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study


Measured Values
    ATV 300 mg / RTV     ATV 400 mg / SQV     LPV / RTV  
Number of Participants Analyzed  
[units: participants]
  120     115     123  
Participants Achieving Virologic Half Log Suppression (LOQ = 400 c/mL) at Week 48, (Overall and by PI Sensitivity)  
[units: participants]
     
Overall (n=120, 115, 123)     77     60     84  
PI Sensitive (n=88, 84, 88)     65     52     67  
PI Resistant (n=32, 30, 33)     12     7     16  

No statistical analysis provided for Participants Achieving Virologic Half Log Suppression (LOQ = 400 c/mL) at Week 48, (Overall and by PI Sensitivity)



7.  Secondary:   Participants Achieving Virologic Half Log Suppression (LOQ = 400 c/mL) at Week 96   [ Time Frame: Baseline, Week 96 ]

Measure Type Secondary
Measure Title Participants Achieving Virologic Half Log Suppression (LOQ = 400 c/mL) at Week 96
Measure Description Number of participants with a >=0.5 log10 decrease in HIV RNA from baseline or HIV RNA < 400 c/mL at Week 96.
Time Frame Baseline, Week 96  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Observed case analysis: Randomized participants (while on initial regimen--completers censored) with baseline and on-study measurement.

Reporting Groups
  Description
ATV 300 mg / RTV

ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice

ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

LPV / RTV

LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice

LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study


Measured Values
    ATV 300 mg / RTV     LPV / RTV  
Number of Participants Analyzed  
[units: participants]
  120     113  
Participants Achieving Virologic Half Log Suppression (LOQ = 400 c/mL) at Week 96  
[units: participants]
  61     58  


Statistical Analysis 1 for Participants Achieving Virologic Half Log Suppression (LOQ = 400 c/mL) at Week 96
Groups [1] All groups
Difference estimate [2] -0.5
95% Confidence Interval ( -13.3 to 12.3 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Randomized participants
[2] Other relevant estimation information:
  ATV 300/RTV - LPV/RTV



8.  Secondary:   Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 24   [ Time Frame: Week 24 ]

Measure Type Secondary
Measure Title Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 24
Measure Description No text entered.
Time Frame Week 24  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Randomized participants; as-randomized population (refers to the treatment regimen assigned at randomization).

Reporting Groups
  Description
ATV 300 mg / RTV

ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice

ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

ATV 400 mg / SQV

ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice

ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

LPV / RTV

LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice

LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study


Measured Values
    ATV 300 mg / RTV     ATV 400 mg / SQV     LPV / RTV  
Number of Participants Analyzed  
[units: participants]
  120     115     123  
Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 24  
[units: participants]
  95     74     93  


Statistical Analysis 1 for Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 24
Groups [1] ATV 400 mg / SQV vs. LPV / RTV
Difference Estimate [2] 3.6
95% Confidence Interval ( -7.0 to 14.1 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 24
Groups [1] ATV 400 mg / SQV vs. LPV / RTV
Difference Estimate [2] -11.3
95% Confidence Interval ( -22.9 to 0.4 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant estimation information:
  No text entered.



9.  Secondary:   Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 24, by PI Sensitivity   [ Time Frame: Baseline, Week 24 ]

Measure Type Secondary
Measure Title Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 24, by PI Sensitivity
Measure Description Number of participants with a >=0.5 log10 decrease in HIV RNA from baseline or HIV RNA < 50 c/mL at Week 24, by their baseline phenotypic sensitivity to their randomized PI.
Time Frame Baseline, Week 24  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As there were multiple efficacy algorithms run and multiple subsets analyzed, it was decided to only use LOQ < 50 on the primary endpoint, and to run LOQ<400 for subsets such as baseline PI sensitivity.

Reporting Groups
  Description
ATV 300 mg / RTV

ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice

ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

ATV 400 mg / SQV

ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice

ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

LPV / RTV

LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice

LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study


Measured Values
    ATV 300 mg / RTV     ATV 400 mg / SQV     LPV / RTV  
Number of Participants Analyzed  
[units: participants]
  0     0     0  
Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 24, by PI Sensitivity  
[units: participants]
           

No statistical analysis provided for Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 24, by PI Sensitivity



10.  Secondary:   Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 48   [ Time Frame: Week 48 ]

Measure Type Secondary
Measure Title Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 48
Measure Description No text entered.
Time Frame Week 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Randomized participants; as-randomized population (refers to the treatment regimen assigned at randomization).

Reporting Groups
  Description
ATV 300 mg / RTV

ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice

ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

ATV 400 mg / SQV

ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice

ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

LPV / RTV

LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice

LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study


Measured Values
    ATV 300 mg / RTV     ATV 400 mg / SQV     LPV / RTV  
Number of Participants Analyzed  
[units: participants]
  120     115     123  
Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 48  
[units: Participants]
  76     60     84  


Statistical Analysis 1 for Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 48
Groups [1] ATV 300 mg / RTV vs. LPV / RTV
Difference Estimate [2] -5.0
95% Confidence Interval ( -16.9 to 7.0 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 48
Groups [1] ATV 400 mg / SQV vs. LPV / RTV
Difference Estimate [2] -16.1
95% Confidence Interval ( -28.5 to -3.7 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant estimation information:
  No text entered.



11.  Secondary:   Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 48, by PI Sensitivity   [ Time Frame: Baseline, Week 48 ]

Measure Type Secondary
Measure Title Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 48, by PI Sensitivity
Measure Description Number of participants with a >=0.5 log10 decrease in HIV RNA from baseline or HIV RNA < 50 c/mL at Week 48, by their baseline phenotypic sensitivity to their randomized PI.
Time Frame Baseline, Week 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As there were multiple efficacy algorithms run and multiple subsets analyzed, it was decided to only use LOQ < 50 on the primary endpoint, and to run LOQ<400 for subsets such as baseline PI sensitivity.

Reporting Groups
  Description
ATV 300 mg / RTV

ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice

ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

ATV 400 mg / SQV

ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice

ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

LPV / RTV

LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice

LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study


Measured Values
    ATV 300 mg / RTV     ATV 400 mg / SQV     LPV / RTV  
Number of Participants Analyzed  
[units: participants]
  0     0     0  
Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 48, by PI Sensitivity  
[units: participants]
           

No statistical analysis provided for Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 48, by PI Sensitivity



12.  Secondary:   Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 96   [ Time Frame: Week 96 ]

Measure Type Secondary
Measure Title Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 96
Measure Description No text entered.
Time Frame Week 96  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Randomized participants while on initial regimen (completers censored).

Reporting Groups
  Description
ATV 300 mg / RTV

ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice

ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

LPV / RTV

LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice

LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study


Measured Values
    ATV 300 mg / RTV     LPV / RTV  
Number of Participants Analyzed  
[units: participants]
  120     113  
Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 96  
[units: Participants]
  61     57  


Statistical Analysis 1 for Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 96
Groups [1] All groups
Difference Estimate [2] 0.4
95% Confidence Interval ( -12.5 to 13.2 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant estimation information:
  ATV 300/RTV - LPV/RTV



13.  Secondary:   Participants Achieving Treatment Response (LOQ = 400 c/mL) Without Prior Failure at Week 24   [ Time Frame: Week 24 ]

Measure Type Secondary
Measure Title Participants Achieving Treatment Response (LOQ = 400 c/mL) Without Prior Failure at Week 24
Measure Description Treatment Response = confirmed suppression to LOQ (400 c/mL). The Algorithm for Treatment Response Without Prior Failure (TRPWF) = participants staying in response at the analysis timepoint without having an intervening, confirmed rebound.
Time Frame Week 24  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Randomized participants while on initial regimen Randomized participants, (completers censored).

Reporting Groups
  Description
ATV 300 mg / RTV

ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice

ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

ATV 400 mg / SQV

ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice

ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

LPV / RTV

LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice

LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study


Measured Values
    ATV 300 mg / RTV     ATV 400 mg / SQV     LPV / RTV  
Number of Participants Analyzed  
[units: participants]
  120     115     123  
Participants Achieving Treatment Response (LOQ = 400 c/mL) Without Prior Failure at Week 24  
[units: participants]
  76     50     74  


Statistical Analysis 1 for Participants Achieving Treatment Response (LOQ = 400 c/mL) Without Prior Failure at Week 24
Groups [1] ATV 300 mg / RTV vs. LPV / RTV
Difference Estimate [2] 3.2
95% Confidence Interval ( -9.1 to 15.4 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Participants Achieving Treatment Response (LOQ = 400 c/mL) Without Prior Failure at Week 24
Groups [1] ATV 400 mg / SQV vs. LPV / RTV
Difference Estimate [2] -16.7
95% Confidence Interval ( -29.4 to -4.0 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant estimation information:
  No text entered.



14.  Secondary:   Participants Achieving Treatment Response (LOQ = 400 c/mL) Without Prior Failure at Week 48   [ Time Frame: Week 48 ]

Measure Type Secondary
Measure Title Participants Achieving Treatment Response (LOQ = 400 c/mL) Without Prior Failure at Week 48
Measure Description Treatment Response = confirmed suppression to LOQ (400 c/mL). The Algorithm for Treatment Response Without Prior Failure (TRPWF) = participants staying in response at the analysis timepoint without having an intervening, confirmed rebound.
Time Frame Week 48  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Randomized participants, as-randomized population (refers to the treatment regimen assigned at randomization).

Reporting Groups
  Description
ATV 300 mg / RTV

ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice

ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

ATV 400 mg / SQV

ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice

ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

LPV / RTV

LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice

LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study


Measured Values
    ATV 300 mg / RTV     ATV 400 mg / SQV     LPV / RTV  
Number of Participants Analyzed  
[units: participants]
  120     115     123  
Participants Achieving Treatment Response (LOQ = 400 c/mL) Without Prior Failure at Week 48  
[units: participants]
  64     42     67  


Statistical Analysis 1 for Participants Achieving Treatment Response (LOQ = 400 c/mL) Without Prior Failure at Week 48
Groups [1] ATV 300 mg / RTV vs. LPV / RTV
Difference Estimate [2] -1.1
95% Confidence Interval ( -13.7 to 11.4 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Participants Achieving Treatment Response (LOQ = 400 c/mL) Without Prior Failure at Week 48
Groups [1] ATV 400 mg / SQV vs. LPV / RTV
Difference Estimate [2] -17.9
95% Confidence Interval ( -30.6 to -5.3 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant estimation information:
  No text entered.



15.  Secondary:   Participants Achieving Treatment Response (LOQ = 400 c/mL) Without Prior Failure at Week 96   [ Time Frame: Week 96 ]

Measure Type Secondary
Measure Title Participants Achieving Treatment Response (LOQ = 400 c/mL) Without Prior Failure at Week 96
Measure Description Treatment Response = confirmed suppression to LOQ (400 c/mL). The Algorithm for Treatment Response Without Prior Failure (TRPWF) = participants staying in response at the analysis timepoint without having an intervening, confirmed rebound.
Time Frame Week 96  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Randomized participants while on initial regimen (completers censored).

Reporting Groups
  Description
ATV 300 mg / RTV

ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice

ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

LPV / RTV

LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice

LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study


Measured Values
    ATV 300 mg / RTV     LPV / RTV  
Number of Participants Analyzed  
[units: participants]
  120     116  
Participants Achieving Treatment Response (LOQ = 400 c/mL) Without Prior Failure at Week 96  
[units: participants]
  52     53  


Statistical Analysis 1 for Participants Achieving Treatment Response (LOQ = 400 c/mL) Without Prior Failure at Week 96
Groups [1] All groups
Method [2] Chi-squared, Corrected
Difference Estimate [3] -2.4
95% Confidence Interval ( -15.0 to 10.3 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  ATV 300/RTV - LPV/RTV



16.  Secondary:   Participants Achieving Treatment Response (LOQ = 50 c/mL) Without Prior Failure at Week 24   [ Time Frame: Week 24 ]

Measure Type Secondary
Measure Title Participants Achieving Treatment Response (LOQ = 50 c/mL) Without Prior Failure at Week 24
Measure Description Treatment Response = confirmed suppression to LOQ (50 c/mL). The Algorithm for Treatment Response Without Prior Failure (TRPWF) = participants staying in response at the analysis timepoint without having an intervening, confirmed rebound.
Time Frame Week 24  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Randomized participants, as-randomized population (refers to the treatment regimen assigned at randomization).

Reporting Groups
  Description
ATV 300 mg / RTV

ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice

ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

ATV 400 mg / SQV

ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice

ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

LPV / RTV

LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice

LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study


Measured Values
    ATV 300 mg / RTV     ATV 400 mg / SQV     LPV / RTV  
Number of Participants Analyzed  
[units: participants]
  120     115     123  
Participants Achieving Treatment Response (LOQ = 50 c/mL) Without Prior Failure at Week 24  
[units: participants]
  46     25     50  


Statistical Analysis 1 for Participants Achieving Treatment Response (LOQ = 50 c/mL) Without Prior Failure at Week 24
Groups [1] ATV 300 mg / RTV vs. LPV / RTV
Difference Estimate [2] -2.3
95% Confidence Interval ( -14.6 to 10.0 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Participants Achieving Treatment Response (LOQ = 50 c/mL) Without Prior Failure at Week 24
Groups [1] ATV 400 mg / SQV vs. LPV / RTV
Difference Estimate [2] -18.9
95% Confidence Interval ( -30.7 to -7.1 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant estimation information:
  No text entered.



17.  Secondary:   Participants Achieving Treatment Response (LOQ = 50 c/mL) Without Prior Failure at Week 48   [ Time Frame: Week 48 ]

Measure Type Secondary
Measure Title Participants Achieving Treatment Response (LOQ = 50 c/mL) Without Prior Failure at Week 48
Measure Description Treatment Response = confirmed suppression to LOQ (50 c/mL). The Algorithm for Treatment Response Without Prior Failure (TRPWF) = participants staying in response at the analysis timepoint without having an intervening, confirmed rebound.
Time Frame Week 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Randomized participantsRandomized participants while on initial regimen (completers censored).

Reporting Groups
  Description
ATV 300 mg / RTV

ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice

ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

ATV 400 mg / SQV

ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice

ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

LPV / RTV

LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice

LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study


Measured Values
    ATV 300 mg / RTV     ATV 400 mg / SQV     LPV / RTV  
Number of Participants Analyzed  
[units: participants]
  120     115     123  
Participants Achieving Treatment Response (LOQ = 50 c/mL) Without Prior Failure at Week 48  
[units: participants]
  43     28     52  


Statistical Analysis 1 for Participants Achieving Treatment Response (LOQ = 50 c/mL) Without Prior Failure at Week 48
Groups [1] ATV 300 mg / RTV vs. LPV / RTV
Difference Estimate [2] -6.4
95% Confidence Interval ( -18.7 to 5.8 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Participants Achieving Treatment Response (LOQ = 50 c/mL) Without Prior Failure at Week 48
Groups [1] ATV 400 mg / SQV vs. LPV / RTV
Difference Estimate [2] -17.9
95% Confidence Interval ( -29.9 to -5.9 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant estimation information:
  No text entered.



18.  Secondary:   Participants Achieving Treatment Response (LOQ = 50 c/mL) Without Prior Failure at Week 96   [ Time Frame: Week 96 ]

Measure Type Secondary
Measure Title Participants Achieving Treatment Response (LOQ = 50 c/mL) Without Prior Failure at Week 96
Measure Description Treatment Response = confirmed suppression to LOQ (50 c/mL). The Algorithm for Treatment Response Without Prior Failure (TRPWF) = participants staying in response at the analysis timepoint without having an intervening, confirmed rebound.
Time Frame Week 96  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Randomized participants while on initial regimen (completers censored)

Reporting Groups
  Description
ATV 300 mg / RTV

ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice

ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

LPV / RTV

LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice

LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study


Measured Values
    ATV 300 mg / RTV     LPV / RTV  
Number of Participants Analyzed  
[units: participants]
  120     118  
Participants Achieving Treatment Response (LOQ = 50 c/mL) Without Prior Failure at Week 96  
[units: participants]
  38     41  

No statistical analysis provided for Participants Achieving Treatment Response (LOQ = 50 c/mL) Without Prior Failure at Week 96



19.  Secondary:   Change From Baseline in CD4 Cell Count at Week 24   [ Time Frame: Baseline, Week 24 ]

Measure Type Secondary
Measure Title Change From Baseline in CD4 Cell Count at Week 24
Measure Description No text entered.
Time Frame Baseline, Week 24  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Randomized participantsRandomized participants while on initial regimen (completers censored).

Reporting Groups
  Description
ATV 300 mg / RTV

ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice

ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

ATV 400 mg / SQV

ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice

ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

LPV / RTV

LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice

LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study


Measured Values
    ATV 300 mg / RTV     ATV 400 mg / SQV     LPV / RTV  
Number of Participants Analyzed  
[units: participants]
  120     115     123  
Change From Baseline in CD4 Cell Count at Week 24  
[units: cells/mm3]
Mean ± Standard Error
  83  ± 14.0     59  ± 11.8     90  ± 15.3  


Statistical Analysis 1 for Change From Baseline in CD4 Cell Count at Week 24
Groups [1] ATV 300 mg / RTV vs. LPV / RTV
Time-Averaged Difference [2] -18.4
97.5% Confidence Interval ( -44.3 to 7.5 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change From Baseline in CD4 Cell Count at Week 24
Groups [1] ATV 400 mg / SQV vs. LPV / RTV
Time-Averaged Difference [2] -44.9
97.5% Confidence Interval ( -74.5 to -15.3 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant estimation information:
  No text entered.



20.  Secondary:   Change From Baseline in CD4 Cell Count at Week 48   [ Time Frame: Baseline, Week 48 ]

Measure Type Secondary
Measure Title Change From Baseline in CD4 Cell Count at Week 48
Measure Description No text entered.
Time Frame Baseline, Week 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Randomized participants while on initial regimen (completers censored).

Reporting Groups
  Description
ATV 300 mg / RTV

ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice

ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

ATV 400 mg / SQV

ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice

ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

LPV / RTV

LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice

LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study


Measured Values
    ATV 300 mg / RTV     ATV 400 mg / SQV     LPV / RTV  
Number of Participants Analyzed  
[units: participants]
  120     115     123  
Change From Baseline in CD4 Cell Count at Week 48  
[units: cells/mm3]
Mean ± Standard Error
  110  ± 22.9     72  ± 19.7     121  ± 20.1  


Statistical Analysis 1 for Change From Baseline in CD4 Cell Count at Week 48
Groups [1] ATV 300 mg / RTV vs. LPV / RTV
Time-Averaged Difference [2] -17.5
97.5% Confidence Interval ( -45.6 to 10.6 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change From Baseline in CD4 Cell Count at Week 48
Groups [1] ATV 400 mg / SQV vs. LPV / RTV
Time-Averaged Difference [2] -47.6
97.5% Confidence Interval ( -79.2 to -16.1 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant estimation information:
  No text entered.



21.  Secondary:   Change From Baseline in CD4 Cell Count at Week 96   [ Time Frame: Baseline, Week 96 ]

Measure Type Secondary
Measure Title Change From Baseline in CD4 Cell Count at Week 96
Measure Description No text entered.
Time Frame Baseline, Week 96  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Randomized participants (while on initial regimen) with evaluation at time point

Reporting Groups
  Description
ATV 300 mg / RTV

ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice

ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

LPV / RTV

LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice

LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study


Measured Values
    ATV 300 mg / RTV     LPV / RTV  
Number of Participants Analyzed  
[units: participants]
  60     60  
Change From Baseline in CD4 Cell Count at Week 96  
[units: cells/mm3]
Mean ± Standard Error
  122  ± 26.3     154  ± 24.2  

No statistical analysis provided for Change From Baseline in CD4 Cell Count at Week 96



22.  Secondary:   Correlation of ATV Minimum Plasma Concentration (Cmin), Inhibitory Quotient (IQ), and Number of Protease Inhibitor (PI) Mutations at Baseline With HIV RNA Change From Baseline at Week 24   [ Time Frame: Baseline, Week 24 ]

Measure Type Secondary
Measure Title Correlation of ATV Minimum Plasma Concentration (Cmin), Inhibitory Quotient (IQ), and Number of Protease Inhibitor (PI) Mutations at Baseline With HIV RNA Change From Baseline at Week 24
Measure Description Pearson correlations of the Cmin (trough plasma concentration), IQ (the ratio of Cmin of ATV to HIV IC50), and Number of baseline PI Mutations with HIV RNA change from baseline at Week 24 were explored.
Time Frame Baseline, Week 24  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Week 24: Participants with evaluable PK measurements

Reporting Groups
  Description
ATV 300 mg / RTV ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice treated participants (HIV RNA change from baseline [log10 c/mL] Mean [SE] = -1.91 [0.19])
ATV 400 mg / SQV ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice treated participants (HIV RNA change from baseline [log10 c/mL] Mean [SE] = -1.57 [0.3])

Measured Values
    ATV 300 mg / RTV     ATV 400 mg / SQV  
Number of Participants Analyzed  
[units: participants]
  40     23  
Correlation of ATV Minimum Plasma Concentration (Cmin), Inhibitory Quotient (IQ), and Number of Protease Inhibitor (PI) Mutations at Baseline With HIV RNA Change From Baseline at Week 24  
[units: Pearson Correlation Coefficient]
   
ATV Cmin     -0.056     0.254  
IQ (<10; >=10)     -0.391     -0.081  
# of PI Mutations at baseline (<4; >=4)     0.306     0.437  


Statistical Analysis 1 for Correlation of ATV Minimum Plasma Concentration (Cmin), Inhibitory Quotient (IQ), and Number of Protease Inhibitor (PI) Mutations at Baseline With HIV RNA Change From Baseline at Week 24
Groups [1] ATV 300 mg / RTV
Method [2] t-test, 1 sided
P Value [3] <0.05
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Correlation between IQ (<10; >=10) of ATV 300 mg / RTV and HIV RNA
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  P-value was based on a t-distribution.

Statistical Analysis 2 for Correlation of ATV Minimum Plasma Concentration (Cmin), Inhibitory Quotient (IQ), and Number of Protease Inhibitor (PI) Mutations at Baseline With HIV RNA Change From Baseline at Week 24
Groups [1] ATV 400 mg / SQV
Method [2] t-test, 1 sided
P Value [3] <0.05
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Correlation between number of PI Mutations at baseline (<4; >=4) of ATV 400 mg / SQV and HIV RNA
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  P-value was based on a t-distribution.



23.  Secondary:   Correlation of ATV Minimum Plasma Concentration (Cmin), Inhibitory Quotient (IQ), and Number of Protease Inhibitor (PI) Mutations at Baseline With HIV RNA Change From Baseline at Week 48   [ Time Frame: Baseline, Week 48 ]

Measure Type Secondary
Measure Title Correlation of ATV Minimum Plasma Concentration (Cmin), Inhibitory Quotient (IQ), and Number of Protease Inhibitor (PI) Mutations at Baseline With HIV RNA Change From Baseline at Week 48
Measure Description Pearson correlations of the Cmin (trough plasma concentration), IQ (the ratio of Cmin of ATV to HIV IC50), and Number of baseline PI Mutations with HIV RNA change from baseline at Week 48 were explored.
Time Frame Baseline, Week 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Formal population PK/PD analysis was not performed due to difficulties in correlating time of blood sample collection with drug administration, and inability to apply the PK model generated with data obtained from healthy subjects due to newly observed differences in exposure to atazanavir between HIV-infected participants and healthy participants.

Reporting Groups
  Description
ATV 300 mg / RTV ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice treated participants (HIV RNA change from baseline [log10 c/mL] Mean [SE] = -1.91 [0.19])
ATV 400 mg / SQV ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice treated participants (HIV RNA change from baseline [log10 c/mL] Mean [SE] = -1.57 [0.3])

Measured Values
    ATV 300 mg / RTV     ATV 400 mg / SQV  
Number of Participants Analyzed  
[units: participants]
  0     0  
Correlation of ATV Minimum Plasma Concentration (Cmin), Inhibitory Quotient (IQ), and Number of Protease Inhibitor (PI) Mutations at Baseline With HIV RNA Change From Baseline at Week 48  
[units: Pearson Correlation Coefficient]
       

No statistical analysis provided for Correlation of ATV Minimum Plasma Concentration (Cmin), Inhibitory Quotient (IQ), and Number of Protease Inhibitor (PI) Mutations at Baseline With HIV RNA Change From Baseline at Week 48



24.  Secondary:   Correlation of ATV Minimum Plasma Concentration (Cmin) Inhibitory Quotient (IQ), and Number of PI Mutations at Baseline and CD4 Cell Count Change From Baseline at Week 24   [ Time Frame: Baseline, Week 24 ]

Measure Type Secondary
Measure Title Correlation of ATV Minimum Plasma Concentration (Cmin) Inhibitory Quotient (IQ), and Number of PI Mutations at Baseline and CD4 Cell Count Change From Baseline at Week 24
Measure Description Pearson correlations of the Cmin (trough plasma concentration), IQ (the ratio of Cmin of ATV to HIV IC50), and Number of baseline PI Mutations with CD4 cell count change from baseline at Week 24 were explored.
Time Frame Baseline, Week 24  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants with evaluable PK measurements, as-randomized population (refers to the treatment regimen assigned at randomization).

Reporting Groups
  Description
ATV 300 mg / RTV ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice treated participants (CD4 Cell Count Change from Baseline [cells/mm3] Mean [SE] = 80 [21])
ATV 400 mg / SQV ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice treated participants (HIV RNA change from baseline [log10 c/mL] Mean [SE] = 56 [20])

Measured Values
    ATV 300 mg / RTV     ATV 400 mg / SQV  
Number of Participants Analyzed  
[units: participants]
  40     23  
Correlation of ATV Minimum Plasma Concentration (Cmin) Inhibitory Quotient (IQ), and Number of PI Mutations at Baseline and CD4 Cell Count Change From Baseline at Week 24  
[units: Pearson Correlation Coefficient]
   
ATV Cmin     0.37     -0.21  
IQ (<10; >=10)     0.376     0.105  
# of PI Mutations at baseline (<4; >=4)     -0.395     -0.227  


Statistical Analysis 1 for Correlation of ATV Minimum Plasma Concentration (Cmin) Inhibitory Quotient (IQ), and Number of PI Mutations at Baseline and CD4 Cell Count Change From Baseline at Week 24
Groups [1] ATV 300 mg / RTV
Method [2] t-test, 1 sided
P Value [3] <0.05
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Correlation between ATV Cmin of ATV 300 mg / RTV and CD4 Cell Count
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  P-value was based on a t-distribution.

Statistical Analysis 2 for Correlation of ATV Minimum Plasma Concentration (Cmin) Inhibitory Quotient (IQ), and Number of PI Mutations at Baseline and CD4 Cell Count Change From Baseline at Week 24
Groups [1] ATV 300 mg / RTV
Method [2] t-test, 1 sided
P Value [3] <0.05
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Correlation between IQ (<10; >=10) of ATV 300 mg / RTV and CD4 Cell Count
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  P-value was based on a t-distribution.

Statistical Analysis 3 for Correlation of ATV Minimum Plasma Concentration (Cmin) Inhibitory Quotient (IQ), and Number of PI Mutations at Baseline and CD4 Cell Count Change From Baseline at Week 24
Groups [1] ATV 300 mg / RTV
Method [2] t-test, 1 sided
P Value [3] <0.05
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Correlation between # of PI Mutations at baseline (<4; >=4) of ATV 300 mg / RTV and CD4 Cell Count
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  P-value was based on a t-distribution.



25.  Secondary:   Correlation of ATV Minimum Plasma Concentration (Cmin) Inhibitory Quotient (IQ), and Number of PI Mutations at Baseline and CD4 Cell Count Change From Baseline at Week 48   [ Time Frame: Baseline, Week 48 ]

Measure Type Secondary
Measure Title Correlation of ATV Minimum Plasma Concentration (Cmin) Inhibitory Quotient (IQ), and Number of PI Mutations at Baseline and CD4 Cell Count Change From Baseline at Week 48
Measure Description Pearson correlations of the Cmin (trough plasma concentration), IQ (the ratio of Cmin of ATV to HIV IC50), and Number of baseline PI Mutations with CD4 cell count change from baseline at Week 48 were explored.
Time Frame Baseline, Week 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Formal population PK/PD analysis was not performed due to difficulties in correlating time of blood sample collection with drug administration, and inability to apply the PK model generated with data obtained from healthy subjects due to newly observed differences in exposure to atazanavir between HIV-infected participants and healthy participants.

Reporting Groups
  Description
ATV 300 mg / RTV ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice treated participants (CD4 Cell Count Change from Baseline [cells/mm3] Mean [SE] = 80 [21])
ATV 400 mg / SQV ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice treated participants (HIV RNA change from baseline [log10 c/mL] Mean [SE] = 56 [20])

Measured Values
    ATV 300 mg / RTV     ATV 400 mg / SQV  
Number of Participants Analyzed  
[units: participants]
  0     0  
Correlation of ATV Minimum Plasma Concentration (Cmin) Inhibitory Quotient (IQ), and Number of PI Mutations at Baseline and CD4 Cell Count Change From Baseline at Week 48  
[units: Pearson Correlation Coefficient]
       

No statistical analysis provided for Correlation of ATV Minimum Plasma Concentration (Cmin) Inhibitory Quotient (IQ), and Number of PI Mutations at Baseline and CD4 Cell Count Change From Baseline at Week 48



26.  Secondary:   Lipid Mean Percent Change From Baseline at Week 24   [ Time Frame: Baseline, Week 24 ]

Measure Type Secondary
Measure Title Lipid Mean Percent Change From Baseline at Week 24
Measure Description Mean percent change in total cholesterol, high density lipoprotein (HDL) cholesterol, fasting low density lipoprotein (LDL) cholesterol, and fasting triglycerides.
Time Frame Baseline, Week 24  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated Participants, Last Observation Carried Forward (LOCF), as-randomized population (refers to the treatment regimen assigned at randomization).

Reporting Groups
  Description
ATV 300 mg / RTV

ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice

ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

ATV 400 mg / SQV

ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice

ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

LPV / RTV

LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice

LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study


Measured Values
    ATV 300 mg / RTV     ATV 400 mg / SQV     LPV / RTV  
Number of Participants Analyzed  
[units: participants]
  119     110     118  
Lipid Mean Percent Change From Baseline at Week 24  
[units: percent change]
     
Total Cholesterol     -8     -9     3  
High Density Lipoprotein (HDL) Cholesterol     -7     -1     0  
Fasting Low Density Lipoprotein (LDL) Cholesterol     -10     -11     -4  
Fasting Triglycerides     -2     -14     31  


Statistical Analysis 1 for Lipid Mean Percent Change From Baseline at Week 24
Groups [1] ATV 300 mg / RTV vs. LPV / RTV
Difference Estimate [2] -10.9
95% Confidence Interval ( -15.5 to -6.0 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Total Cholesterol
[2] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Lipid Mean Percent Change From Baseline at Week 24
Groups [1] ATV 400 mg / SQV vs. LPV / RTV
Difference Estimate [2] -12.4
95% Confidence Interval ( -16.9 to -7.6 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Total Cholesterol
[2] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Lipid Mean Percent Change From Baseline at Week 24
Groups [1] ATV 300 mg / RTV vs. LPV / RTV
Difference Estimate [2] -6.7
95% Confidence Interval ( -13.6 to 0.7 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  HDL cholesterol
[2] Other relevant estimation information:
  No text entered.

Statistical Analysis 4 for Lipid Mean Percent Change From Baseline at Week 24
Groups [1] ATV 400 mg / SQV vs. LPV / RTV
Difference Estimate [2] -1.0
95% Confidence Interval ( -9.3 to 8.1 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  HDL Cholesterol
[2] Other relevant estimation information:
  No text entered.

Statistical Analysis 5 for Lipid Mean Percent Change From Baseline at Week 24
Groups [1] ATV 300 mg / RTV vs. LPV / RTV
Difference Estimate [2] -6.8
95% Confidence Interval ( -15.6 to 3.0 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Fasting LDL Cholesterol
[2] Other relevant estimation information:
  No text entered.

Statistical Analysis 6 for Lipid Mean Percent Change From Baseline at Week 24
Groups [1] ATV 400 mg / SQV vs. LPV / RTV
Difference Estimate [2] -7.3
95% Confidence Interval ( -15.5 to 1.8 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Fasting LDL Cholesterol
[2] Other relevant estimation information:
  No text entered.

Statistical Analysis 7 for Lipid Mean Percent Change From Baseline at Week 24
Groups [1] ATV 300 mg / RTV vs. LPV / RTV
Difference Estimate [2] -24.9
95% Confidence Interval ( -35.0 to -13.2 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Fasting Triglycerides
[2] Other relevant estimation information:
  No text entered.

Statistical Analysis 8 for Lipid Mean Percent Change From Baseline at Week 24
Groups [1] ATV 400 mg / SQV vs. LPV / RTV
Difference Estimate [2] -34.2
95% Confidence Interval ( -43.4 to -23.4 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Fasting Triglycerides
[2] Other relevant estimation information:
  No text entered.



27.  Secondary:   Lipid Mean Percent Change From Baseline at Week 48   [ Time Frame: Week 48 ]

Measure Type Secondary
Measure Title Lipid Mean Percent Change From Baseline at Week 48
Measure Description Mean percent change in total cholesterol, high density lipoprotein (HDL) cholesterol, fasting low density lipoprotein (LDL) cholesterol, and fasting triglycerides.
Time Frame Week 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated Participants, Last Observation Carried Forward (LOCF); as-randomized population (refers to the treatment regimen assigned at randomization).

Reporting Groups
  Description
ATV 300 mg / RTV

ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice

ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

ATV 400 mg / SQV

ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice

ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

LPV / RTV

LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice

LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study


Measured Values
    ATV 300 mg / RTV     ATV 400 mg / SQV     LPV / RTV  
Number of Participants Analyzed  
[units: participants]
  119     110     118  
Lipid Mean Percent Change From Baseline at Week 48  
[units: percent change in lipid values]
     
Total Cholesterol     -8     -4     6  
HDL Cholesterol     -7     4     2  
Fasting LDL Cholesterol     -10     -3     1  
Fasting Triglycerides     -4     -14     30  


Statistical Analysis 1 for Lipid Mean Percent Change From Baseline at Week 48
Groups [1] ATV 300 mg / RTV vs. LPV / RTV
Difference Estimate [2] -12.1
95% Confidence Interval ( -17.0 to -7.2 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Total Cholesterol
[2] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Lipid Mean Percent Change From Baseline at Week 48
Groups [1] ATV 400 mg / SQV vs. LPV / RTV
Difference Estimate [2] -12.0
95% Confidence Interval ( -17.4 to -6.5 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Total Cholesterol
[2] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Lipid Mean Percent Change From Baseline at Week 48
Groups [1] ATV 300 mg / RTV vs. LPV / RTV
Difference Estimate [2] -4.4
95% Confidence Interval ( -12.4 to 3.5 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  HDL Cholesterol
[2] Other relevant estimation information:
  No text entered.

Statistical Analysis 4 for Lipid Mean Percent Change From Baseline at Week 48
Groups [1] ATV 400 mg / SQV vs. LPV / RTV
DIfference Estimate [2] -0.8
95% Confidence Interval ( -11.0 to 9.3 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  HDL Cholesterol
[2] Other relevant estimation information:
  No text entered.

Statistical Analysis 5 for Lipid Mean Percent Change From Baseline at Week 48
Groups [1] ATV 300 mg / RTV vs. LPV / RTV
Difference Estimate [2] -8.9
95% Confidence Interval ( -19.0 to 1.2 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Fasting LDL CHolesterol
[2] Other relevant estimation information:
  No text entered.

Statistical Analysis 6 for Lipid Mean Percent Change From Baseline at Week 48
Groups [1] ATV 400 mg / SQV vs. LPV / RTV
Difference Estimate [2] -7.4
95% Confidence Interval ( -17.7 to 3.0 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Fasting LDL Cholesterol
[2] Other relevant estimation information:
  No text entered.

Statistical Analysis 7 for Lipid Mean Percent Change From Baseline at Week 48
Groups [1] ATV 300 mg / RTV vs. LPV / RTV
Difference Estimate [2] -29.6
95% Confidence Interval ( -41.6 to -17.7 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Fasting Triglycerides
[2] Other relevant estimation information:
  No text entered.

Statistical Analysis 8 for Lipid Mean Percent Change From Baseline at Week 48
Groups [1] ATV 400 mg / SQV vs. LPV / RTV
Difference Estimate [2] -38.4
95% Confidence Interval ( -49.7 to -27.1 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Fasting Triglycerides
[2] Other relevant estimation information:
  No text entered.



28.  Secondary:   Lipid Mean Percent Change From Baseline at Week 96, Observed Values   [ Time Frame: Week 96 ]

Measure Type Secondary
Measure Title Lipid Mean Percent Change From Baseline at Week 96, Observed Values
Measure Description Mean percent change in total cholesterol, high density lipoprotein (HDL) cholesterol, fasting low density lipoprotein (LDL) cholesterol, and fasting triglycerides.
Time Frame Week 96  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated Participants; as-randomized population (refers to the treatment regimen assigned at randomization).

Reporting Groups
  Description
ATV 300 mg / RTV

ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice

ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

ATV 400 mg / SQV

ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice

ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

LPV / RTV

LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice

LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study


Measured Values
    ATV 300 mg / RTV     ATV 400 mg / SQV     LPV / RTV  
Number of Participants Analyzed  
[units: participants]
  119     110     118  
Lipid Mean Percent Change From Baseline at Week 96, Observed Values  
[units: percent change in lipid values]
     
Total Cholesterol (n=60, 46, 54)     -7     -1     9  
HDL Cholesterol (n=60, 46, 54)     -5     3     7  
Fasting LDL Cholesterol (n=52, 39, 43)     -11     -7     1  
Fasting Triglycerides (n=52, 40, 43)     -2     4     30  


Statistical Analysis 1 for Lipid Mean Percent Change From Baseline at Week 96, Observed Values
Groups [1] ATV 300 mg / RTV vs. LPV / RTV
Difference Estimate [2] -14.4
95% Confidence Interval ( -20.1 to -8.3 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Observed values, Total Cholesterol
[2] Other relevant estimation information:
  ATV 300/RTV - LPV/RTV

Statistical Analysis 2 for Lipid Mean Percent Change From Baseline at Week 96, Observed Values
Groups [1] ATV 400 mg / SQV vs. LPV / RTV
Difference Estimate [2] -9.0
95% Confidence Interval ( -16.1 to -1.3 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  observed values, total cholesterol
[2] Other relevant estimation information:
  ATV 400/SQV - LPV/RTV

Statistical Analysis 3 for Lipid Mean Percent Change From Baseline at Week 96, Observed Values
Groups [1] ATV 300 mg / RTV vs. LPV / RTV
Difference Estimate [2] -11.0
95% Confidence Interval ( -19.9 to -1.2 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  observed values, HDL cholesterol
[2] Other relevant estimation information:
  ATV 300/RTV - LPV/RTV

Statistical Analysis 4 for Lipid Mean Percent Change From Baseline at Week 96, Observed Values
Groups [1] ATV 400 mg / SQV vs. LPV / RTV
Difference Estimate [2] -4.1
95% Confidence Interval ( -14.0 to 7.0 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Observed values, HDL cholesterol
[2] Other relevant estimation information:
  ATV 400/SQV - LPV/RTV

Statistical Analysis 5 for Lipid Mean Percent Change From Baseline at Week 96, Observed Values
Groups [1] ATV 300 mg / RTV vs. LPV / RTV
Difference Estimate [2] -12.7
95% Confidence Interval ( -22.3 to -1.8 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  observed cases, fasting LDL
[2] Other relevant estimation information:
  ATV 300/RTV - LPV/RTV

Statistical Analysis 6 for Lipid Mean Percent Change From Baseline at Week 96, Observed Values
Groups [1] ATV 400 mg / SQV vs. LPV / RTV
Difference Estimate [2] -7.9
95% Confidence Interval ( -19.0 to 4.8 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Observed Cases, Fasting LDL cholesterol
[2] Other relevant estimation information:
  ATV 400/SQV - LPV/RTV

Statistical Analysis 7 for Lipid Mean Percent Change From Baseline at Week 96, Observed Values
Groups [1] ATV 300 mg / RTV vs. LPV / RTV
Difference Estimate [2] -24.8
95% Confidence Interval ( -38.6 to -8.0 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  observed cases, fasting triglycerides
[2] Other relevant estimation information:
  ATV 300/RTV - LPV/RTV

Statistical Analysis 8 for Lipid Mean Percent Change From Baseline at Week 96, Observed Values
Groups [1] ATV 400 mg / SQV vs. LPV / RTV
Difference Estimate [2] -19.8
95% Confidence Interval ( -36.5 to 1.3 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  observed cases, fasting triglycerides
[2] Other relevant estimation information:
  ATV 400/SQV - LPV/RTV



29.  Secondary:   Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs) Through Week 48   [ Time Frame: From Enrollment through Week 48 ]

Measure Type Secondary
Measure Title Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs) Through Week 48
Measure Description AE=any new untoward medical occurrence/worsening of a pre-existing medical condition regardless of causal relationship. SAE=any untoward medical occurrence at any dose that: results in death; is life-threatening; requires/prolongs inpatient hospitalization; results in persistent/significant disability; is cancer; is congenital anomaly/birth defect; results in drug dependency/abuse; is an important medical event.
Time Frame From Enrollment through Week 48  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Randomized participants for Deaths and SAEs; treated participants for all others; as-randomized population (refers to the treatment regimen assigned at randomization). In addition, of the 213 screen failures (not randomized), there were 4 subjects who had an SAE; these are not included in the table below.

Reporting Groups
  Description
ATV 300 mg / RTV

ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice

ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

ATV 400 mg / SQV

ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice

ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

LPV / RTV

LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice

LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study


Measured Values
    ATV 300 mg / RTV     ATV 400 mg / SQV     LPV / RTV  
Number of Participants Analyzed  
[units: participants]
  120     115     123  
Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs) Through Week 48  
[units: participants]
     
Deaths (n = 120, 115, 123)     0     1     1  
AEs leading to discontinuation (n = 119, 110, 118)     6     8     5  
SAEs (n = 120, 115, 123)     12     14     11  
AEs, grades 1-4 (n = 119, 110, 118)     97     93     103  
AEs, grades 3-4 (n = 119, 110, 118)     11     18     12  

No statistical analysis provided for Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs) Through Week 48



30.  Secondary:   Most Common AEs and AEs of Interest Through Week 48   [ Time Frame: From Enrollment to Week 48 ]

Measure Type Secondary
Measure Title Most Common AEs and AEs of Interest Through Week 48
Measure Description Prespecified AEs of interest included jaundice, ocular icterus, and hyperbilirubinemia.
Time Frame From Enrollment to Week 48  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated participants; as-randomized population (refers to the treatment regimen assigned at randomization).

Reporting Groups
  Description
ATV 300 mg / RTV

ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice

ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

ATV 400 mg / SQV

ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice

ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

LPV / RTV

LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice

LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study


Measured Values
    ATV 300 mg / RTV     ATV 400 mg / SQV     LPV / RTV  
Number of Participants Analyzed  
[units: participants]
  119     110     118  
Most Common AEs and AEs of Interest Through Week 48  
[units: participants]
     
Diarrhea (Most Common)     25     29     54  
Headache (Most Common)     21     24     18  
Nausea (Most Common)     19     24     15  
Jaundice (AE of Interest)     19     6     0  
Ocular Icterus (AE of Interest)     13     3     0  
Hyperbilirubinemia (AE of Interest)     24     8     1  

No statistical analysis provided for Most Common AEs and AEs of Interest Through Week 48



31.  Secondary:   Fasting Glucose Mean Change From Baseline at Week 24   [ Time Frame: Baseline, Week 24 ]

Measure Type Secondary
Measure Title Fasting Glucose Mean Change From Baseline at Week 24
Measure Description No text entered.
Time Frame Baseline, Week 24  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated Participants with evaluation at time point; as-randomized population (refers to the treatment regimen assigned at randomization).

Reporting Groups
  Description
ATV 300 mg / RTV

ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice

ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

ATV 400 mg / SQV

ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice

ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

LPV / RTV

LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice

LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study


Measured Values
    ATV 300 mg / RTV     ATV 400 mg / SQV     LPV / RTV  
Number of Participants Analyzed  
[units: participants]
  104     87     99  
Fasting Glucose Mean Change From Baseline at Week 24  
[units: mg/dL]
Mean ± Standard Error
  0  ± 1.6     -3  ± 1.8     0  ± 1.4  

No statistical analysis provided for Fasting Glucose Mean Change From Baseline at Week 24



32.  Secondary:   Fasting Glucose Mean Change From Baseline at Week 48   [ Time Frame: Week 48 ]

Measure Type Secondary
Measure Title Fasting Glucose Mean Change From Baseline at Week 48
Measure Description No text entered.
Time Frame Week 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated Participants with evaluation at time point; as-randomized population (refers to the treatment regimen assigned at randomization).

Reporting Groups
  Description
ATV 300 mg / RTV

ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice

ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

ATV 400 mg / SQV

ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice

ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

LPV / RTV

LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice

LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study


Measured Values
    ATV 300 mg / RTV     ATV 400 mg / SQV     LPV / RTV  
Number of Participants Analyzed  
[units: participants]
  115     108     112  
Fasting Glucose Mean Change From Baseline at Week 48  
[units: mg/dL]
Mean ± Standard Error
  4  ± 3.6     -1  ± 1.6     1  ± 1.5  

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



33.  Secondary:   Grade 3/4 Laboratory Abnormalities Through Week 48   [ Time Frame: From Enrollment to Week 48 ]

Measure Type Secondary
Measure Title Grade 3/4 Laboratory Abnormalities Through Week 48
Measure Description Common Terminology Criteria for Adverse Events v3.0 (CTCAE) Grades:1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death. Abnormal values: absolute neutrophil count: ≥500 to <750/mm3 (grade 3), <500/mm3 (grade 4); platelets: 20,000-49,999/mm3 (grade 3), <20,000/mm3 or diffuse petechiae (grade 4); alanine transaminase (ALT): 5.1-10 x upper limit of normal (ULN; grade 3), >10 x ULN (grade 4); aspartate transaminase (AST): 5.1-10 x ULN (grade 3), >10 x ULN (grade 4); bilirubin: 2.6-5 x ULN (grade 3), >5 x ULN (grade 4).
Time Frame From Enrollment to Week 48  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Evaluable treated participants; as-randomized population (refers to the treatment regimen assigned at randomization).

Reporting Groups
  Description
ATV 300 mg / RTV

ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice

ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

ATV 400 mg / SQV

ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice

ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

LPV / RTV

LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice

LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study


Measured Values
    ATV 300 mg / RTV     ATV 400 mg / SQV     LPV / RTV  
Number of Participants Analyzed  
[units: participants]
  119     108     118  
Grade 3/4 Laboratory Abnormalities Through Week 48  
[units: participants]
     
Neutrophil Reduction     8     8     10  
Platelet Reduction     2     4     3  
ALT Elevation     5     4     4  
AST Elevation     4     2     4  
Total Bilirubin Elevation     58     22     1  

No statistical analysis provided for Grade 3/4 Laboratory Abnormalities Through Week 48



34.  Secondary:   Fridericia-corrected QT (QTcF) Interval and Change From Baseline by Analysis Time Point   [ Time Frame: Baseline, Week 4 predose, 2-3 hours postdose, 6-12 hours postdose, Week 12, Week 24, Week 48 ]

Measure Type Secondary
Measure Title Fridericia-corrected QT (QTcF) Interval and Change From Baseline by Analysis Time Point
Measure Description The QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. The QT interval was corrected for heart rate using Fridericia's (QTcF) formula.
Time Frame Baseline, Week 4 predose, 2-3 hours postdose, 6-12 hours postdose, Week 12, Week 24, Week 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated participants; as-randomized population (refers to the treatment regimen assigned at randomization). n=number of participants evaluated at timepoint

Reporting Groups
  Description
ATV 300 mg / RTV

ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice

ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

ATV 400 mg / SQV

ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice

ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

LPV / RTV

LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice

LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study


Measured Values
    ATV 300 mg / RTV     ATV 400 mg / SQV     LPV / RTV  
Number of Participants Analyzed  
[units: participants]
  119     110     118  
Fridericia-corrected QT (QTcF) Interval and Change From Baseline by Analysis Time Point  
[units: msec]
Mean ± Standard Error
     
Baseline Mean (n=119, 110, 118)     390  ± 1.9     387  ± 2.2     390  ± 1.9  
Mean Change at Week 4 predose (n=117, 104, 110)     -3  ± 1.6     1  ± 1.9     -2  ± 1.7  
Mean Change Wk 4 2-3 hrs postdose (n=113,102,106)     -2  ± 1.6     -3  ± 2.0     -7  ± 1.9  
Mean Change Wk 4 6-12 hrs postdose (n=112,101,105)     -4  ± 1.7     -1  ± 1.9     -8  ± 1.8  
Mean Change at Week 12 (n=110, 97, 107)     2  ± 1.6     3  ± 2.0     2  ± 1.6  
Mean Change at Week 24 (n=108, 92, 109)     1  ± 1.8     3  ± 2.2     2  ± 1.8  
Mean Change at Week 48 (n=89, 75, 97)     -1  ± 1.8     -1  ± 2.1     0  ± 2.0  

No statistical analysis provided for Fridericia-corrected QT (QTcF) Interval and Change From Baseline by Analysis Time Point



35.  Secondary:   PR Interval and Change From Baseline by Analysis Time Point   [ Time Frame: Baseline, Week 4 predose, 2-3 hours postdose, 6-12 hours postdose, Week 12, Week 24, Week 48 ]

Measure Type Secondary
Measure Title PR Interval and Change From Baseline by Analysis Time Point
Measure Description The PR interval is measured from the beginning of the P wave to the beginning of the QRS complex, and reflects the time the electrical impulse takes to travel from the sinus node through the atrioventricular (AV) node and entering the ventricles. The PR interval is therefore a good estimate of AV node function.
Time Frame Baseline, Week 4 predose, 2-3 hours postdose, 6-12 hours postdose, Week 12, Week 24, Week 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated participants; as-randomized population (refers to the treatment regimen assigned at randomization). n=number of participants evaluated at timepoint

Reporting Groups
  Description
ATV 300 mg / RTV

ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice

ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

ATV 400 mg / SQV

ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice

ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

LPV / RTV

LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice

LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study


Measured Values
    ATV 300 mg / RTV     ATV 400 mg / SQV     LPV / RTV  
Number of Participants Analyzed  
[units: participants]
  119     110     118  
PR Interval and Change From Baseline by Analysis Time Point  
[units: msec]
Mean ± Standard Error
     
Baseline Mean (n=119, 110, 118)     153  ± 1.7     155  ± 1.9     154  ± 1.7  
Mean Change at Week 4 predose (n=117, 104, 110)     4  ± 1.2     9  ± 1.6     3  ± 1.4  
Mean Change Wk 4 2-3 hrs postdose (n=113,102,106)     1  ± 1.3     6  ± 1.6     1  ± 1.7  
Mean Change Wk 4 6-12 hrs postdose (n=112,101,105)     2  ± 1.4     6  ± 1.7     2  ± 1.5  
Mean Change at Week 12 (n=110, 97, 107)     5  ± 1.6     7  ± 1.7     8  ± 1.4  
Mean Change at Week 24 (n=108, 92, 109)     2  ± 1.3     7  ± 1.7     5  ± 1.6  
Mean Change at Week 48 (n=89, 75, 97)     0  ± 1.5     2  ± 1.9     4  ± 1.7  

No statistical analysis provided for PR Interval and Change From Baseline by Analysis Time Point



36.  Secondary:   Adherence to Regimen Though Week 48 Based on MACS the Multicenter AIDS Cohort Study (MACS) Adherence Questionnaire   [ Time Frame: Baseline, Week 24, Week 48 ]

Measure Type Secondary
Measure Title Adherence to Regimen Though Week 48 Based on MACS the Multicenter AIDS Cohort Study (MACS) Adherence Questionnaire
Measure Description The MACS adherence questionnaire asks patients how many medication doses they missed during the previous day, 2 days, 3 days and 4 days. Drug-specific questions included adherence with dose and frequency. Adherence was defined as taking all doses and numbers of pills as prescribed for each medication. 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 Baseline, Week 24, Week 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Number of Participants Analyzed=treated participants; as-randomized population (refers to the treatment regimen assigned at randomization); n=subset of treated participants (Given the language limitation, a subset of the AI424045 population was included in the MACS adherence analysis.)

Reporting Groups
  Description
ATV 300 mg / RTV

ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice

ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

ATV 400 mg / SQV

ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice

ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

LPV / RTV

LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice

LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study


Measured Values
    ATV 300 mg / RTV     ATV 400 mg / SQV     LPV / RTV  
Number of Participants Analyzed  
[units: participants]
  40     33     48  
Adherence to Regimen Though Week 48 Based on MACS the Multicenter AIDS Cohort Study (MACS) Adherence Questionnaire  
[units: participants]
     
Adherent at Baseline (n=27, 25, 33)     12     10     18  
Adherent at Week 24 (n=18, 11, 25)     10     5     23  
Adherent at Week 48 (n=11, 4, 20)     8     2     13  

No statistical analysis provided for Adherence to Regimen Though Week 48 Based on MACS the Multicenter AIDS Cohort Study (MACS) Adherence Questionnaire



37.  Secondary:   Mean Score of European Quality of Life-5 Dimensions (EQ-5D) Health Index Score at Baseline, Mid-Study (Week 24), and Final (Week 48)   [ Time Frame: Baseline, Week 24, Week 48 ]

Measure Type Secondary
Measure Title Mean Score of European Quality of Life-5 Dimensions (EQ-5D) Health Index Score at Baseline, Mid-Study (Week 24), and Final (Week 48)
Measure Description The EQ-5D is a 5-item questionnaire to assess health-related quality of life in 5 health dimensions (mobility, self-care, usual activity, pain/discomfort, anxiety/depression) are scored on a 3-level scale: no problems (1), some problems (2), extreme problems (3). Using a standard algorithm, responses are summarized into a single score, the EQ-5D Health Index Score (HIS), which ranges between 1 (representing perfect health) and 0 (representing the worst imaginable health state or death). The smallest coefficient of change is 0.03.
Time Frame Baseline, Week 24, Week 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated participants; as-randomized population (refers to the treatment regimen assigned at randomization). n=number of participants evaluated with EQ-5D at given time point.

Reporting Groups
  Description
ATV 300 mg / RTV

ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice

ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

ATV 400 mg / SQV

ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice

ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

LPV / RTV

LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice

LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study


Measured Values
    ATV 300 mg / RTV     ATV 400 mg / SQV     LPV / RTV  
Number of Participants Analyzed  
[units: participants]
  119     110     118  
Mean Score of European Quality of Life-5 Dimensions (EQ-5D) Health Index Score at Baseline, Mid-Study (Week 24), and Final (Week 48)  
[units: units on a scale]
Mean ± Standard Error
     
Baseline (n=99, 86, 100)     0.83  ± 0.02     0.85  ± 0.02     0.86  ± 0.02  
Mid-Study (n=103, 83, 95)     0.87  ± 0.02     0.86  ± 0.02     0.89  ± 0.01  
Final (n=93, 84, 96)     0.84  ± 0.02     0.85  ± 0.03     0.88  ± 0.02  

No statistical analysis provided for Mean Score of European Quality of Life-5 Dimensions (EQ-5D) Health Index Score at Baseline, Mid-Study (Week 24), and Final (Week 48)



38.  Secondary:   Mean Score of European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) at Baseline, Mid-Study (Week 24), and Final (Week 48)   [ Time Frame: Baseline, Week 24, Week 48 ]

Measure Type Secondary
Measure Title Mean Score of European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) at Baseline, Mid-Study (Week 24), and Final (Week 48)
Measure Description The EQ-5D has a Visual Analog Scale (VAS), which is a feeling thermometer-like scale with a range between 0 and 100. Patients are required to draw a line from a box on the VAS scale to an actual mark on the thermometer-like scale that corresponds with a number that reflects their self-assessed health status at the time they are completing the questionnaire. Higher VAS scores indicate better overall health. There is no minimum clinically important difference reported in the literature for VAS.
Time Frame Baseline, Week 24, Week 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated participants; as-randomized population (refers to the treatment regimen assigned at randomization). n=number of participants evaluated with EQ-5D at given time point.

Reporting Groups
  Description
ATV 300 mg / RTV

ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice

ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

ATV 400 mg / SQV

ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice

ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

LPV / RTV

LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice

LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study


Measured Values
    ATV 300 mg / RTV     ATV 400 mg / SQV     LPV / RTV  
Number of Participants Analyzed  
[units: participants]
  119     110     118  
Mean Score of European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) at Baseline, Mid-Study (Week 24), and Final (Week 48)  
[units: units on a scale]
Mean ± Standard Error
     
Baseline (n=98, 85, 101)     81.33  ± 1.63     81.72  ± 1.77     81.52  ± 1.53  
Mid-Study (n=102, 83, 97)     84.89  ± 1.65     83.34  ± 1.89     85.09  ± 1.55  
Final (n=95, 81, 96)     82.77  ± 1.72     85.80  ± 1.64     86.16  ± 1.36  

No statistical analysis provided for Mean Score of European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) at Baseline, Mid-Study (Week 24), and Final (Week 48)



39.  Secondary:   Number of Participants Utilizing Resources for Managing Lipid Elevation   [ Time Frame: Baseline, Week 24, Week 48 ]

Measure Type Secondary
Measure Title Number of Participants Utilizing Resources for Managing Lipid Elevation
Measure Description Participants' overall resource utilization for managing lipid elevation that includes the management of side effects of lipid lowering medications, such as those due to drug interactions.
Time Frame Baseline, Week 24, Week 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Although the intent of this planned analysis was to provide a model of economic value for Lipid Management, a different approach was taken to create this model which did not require data from this trial, and thus this analysis was not done.

Reporting Groups
  Description
ATV 300 mg / RTV

ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice

ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

ATV 400 mg / SQV

ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice

ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

LPV / RTV

LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice

LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study


Measured Values
    ATV 300 mg / RTV     ATV 400 mg / SQV     LPV / RTV  
Number of Participants Analyzed  
[units: participants]
  0     0     0  
Number of Participants Utilizing Resources for Managing Lipid Elevation  
[units: Participants]
           

No statistical analysis provided for Number of Participants Utilizing Resources for Managing Lipid Elevation



40.  Secondary:   Mean ATV, RTV and SQV Minimum Concentration (Cmin) Values   [ Time Frame: collected at the pre-dose time point after receiving atazanavir for at least four weeks ]

Measure Type Secondary
Measure Title Mean ATV, RTV and SQV Minimum Concentration (Cmin) Values
Measure Description The minimum or "trough" concentration (Cmin) of a drug observed after its administration and just prior to the administration of a subsequent dose.
Time Frame collected at the pre-dose time point after receiving atazanavir for at least four weeks  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants with evaluable Cmins; as-randomized population (refers to the treatment regimen assigned at randomization).

Reporting Groups
  Description
ATV 300 mg / RTV

ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice

ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

ATV 400 mg / SQV

ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice

ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study


Measured Values
    ATV 300 mg / RTV     ATV 400 mg / SQV  
Number of Participants Analyzed  
[units: participants]
  40     23  
Mean ATV, RTV and SQV Minimum Concentration (Cmin) Values  
[units: ng/mL]
Mean ± Standard Error
   
ATV (n=40,23)     719.53  ± 82.81     312.01  ± 145.31  
RTV (n=40,0)     154.83  ± 39.31     NA  ± NA [1]
SQV (n=0,19)     NA  ± NA [2]   52.15  ± 16.89  
[1] No participants were analyzed in this cohort for RTV because they did not take this drug.
[2] No participants were analyzed in this cohort for SQV because they did not take this drug.

No statistical analysis provided for Mean ATV, RTV and SQV Minimum Concentration (Cmin) Values



41.  Secondary:   HIV IC50 at Week 24   [ Time Frame: Week 24 ]

Measure Type Secondary
Measure Title HIV IC50 at Week 24
Measure Description IC50: inhibitory concentration of drug required to reduce viral replication by 50%.
Time Frame Week 24  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants with evaluable IC50 measurements; as-randomized population (refers to the treatment regimen assigned at randomization).

Reporting Groups
  Description
ATV 300 mg / RTV

ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice

ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

ATV 400 mg / SQV

ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice

ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study


Measured Values
    ATV 300 mg / RTV     ATV 400 mg / SQV  
Number of Participants Analyzed  
[units: participants]
  40     21  
HIV IC50 at Week 24  
[units: ng/mL]
Mean ± Standard Error
  17.83  ± 4.04     22.84  ± 11.65  

No statistical analysis provided for HIV IC50 at Week 24



42.  Secondary:   Inhibitory Quotient at Week 24   [ Time Frame: Baseline, Week 24 ]

Measure Type Secondary
Measure Title Inhibitory Quotient at Week 24
Measure Description Inhibitory quotient is a measure of drug exposure and susceptibility in an individual. The IQ is typically calculated as the ratio of Cmin to HIV IC50.
Time Frame Baseline, Week 24  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants with evaluable IQ measurements (ie, must have both Cmin and IC50 measurements); as-randomized population (refers to the treatment regimen assigned at randomization).

Reporting Groups
  Description
ATV 300 mg / RTV

ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice

ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

ATV 400 mg / SQV

ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice

ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study


Measured Values
    ATV 300 mg / RTV     ATV 400 mg / SQV  
Number of Participants Analyzed  
[units: participants]
  40     21  
Inhibitory Quotient at Week 24  
[units: ratio]
Mean ± Standard Error
  136.94  ± 24.33     25.04  ± 13.33  

No statistical analysis provided for Inhibitory Quotient at Week 24



43.  Secondary:   Inhibitory Quotient at Week 48   [ Time Frame: Baseline, Week 48 ]

Measure Type Secondary
Measure Title Inhibitory Quotient at Week 48
Measure Description Inhibitory quotient is a measure of drug exposure and susceptibility in an individual. The IQ is typically calculated as the ratio of Cmin to HIV IC50.
Time Frame Baseline, Week 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Formal population PK/PD analysis was not performed due to difficulties in correlating time of blood sample collection with drug administration, and inability to apply the PK model generated with data obtained from healthy subjects due to newly observed differences in exposure to atazanavir between HIV-infected participants and healthy participants.

Reporting Groups
  Description
ATV 300 mg / RTV

ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice

ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

ATV 400 mg / SQV

ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice

ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study


Measured Values
    ATV 300 mg / RTV     ATV 400 mg / SQV  
Number of Participants Analyzed  
[units: participants]
  0     0  
Inhibitory Quotient at Week 48  
[units: ratio]
Mean ± Standard Error
       

No statistical analysis provided for Inhibitory Quotient at Week 48



44.  Secondary:   HIV RNA Level - Treated Subjects With Evaluable Cmins at Week 24   [ Time Frame: Baseline, Week 24 ]

Measure Type Secondary
Measure Title HIV RNA Level - Treated Subjects With Evaluable Cmins at Week 24
Measure Description Week 24 HIV RNA level and change from baseline were summarized for treated subjects with evaluable Cmins.
Time Frame Baseline, Week 24  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants with evaluable Cmins; as-randomized population (refers to the treatment regimen assigned at randomization).

Reporting Groups
  Description
ATV 300 mg / RTV

ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice

ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

ATV 400 mg / SQV

ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice

ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study


Measured Values
    ATV 300 mg / RTV     ATV 400 mg / SQV  
Number of Participants Analyzed  
[units: participants]
  40     23  
HIV RNA Level - Treated Subjects With Evaluable Cmins at Week 24  
[units: log10 c/mL]
Mean ± Standard Error
   
Baseline Values     4.53  ± 0.13     4.41  ± 0.13  
Week 24 Values     2.62  ± 0.19     2.83  ± 0.25  
Change from Baseline at Week 24     -1.91  ± 0.19     -1.57  ± 0.29  

No statistical analysis provided for HIV RNA Level - Treated Subjects With Evaluable Cmins at Week 24



45.  Secondary:   HIV RNA Level - Treated Subjects With Evaluable Cmins at Week 48   [ Time Frame: Baseline, Week 48 ]

Measure Type Secondary
Measure Title HIV RNA Level - Treated Subjects With Evaluable Cmins at Week 48
Measure Description Week 24 HIV RNA level and change from baseline were summarized for treated subjects with evaluable Cmins.
Time Frame Baseline, Week 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Formal population PK/PD analysis was not performed due to difficulties in correlating time of blood sample collection with drug administration, and inability to apply the PK model generated with data obtained from healthy subjects due to newly observed differences in exposure to atazanavir between HIV-infected participants and healthy participants.

Reporting Groups
  Description
ATV 300 mg / RTV

ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice

ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study

ATV 400 mg / SQV

ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice

ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study


Measured Values
    ATV 300 mg / RTV     ATV 400 mg / SQV  
Number of Participants Analyzed  
[units: participants]
  0     0  
HIV RNA Level - Treated Subjects With Evaluable Cmins at Week 48  
[units: log10 c/mL]
Mean ± Standard Error
       

No statistical analysis provided for HIV RNA Level - Treated Subjects With Evaluable Cmins at Week 48




  Serious Adverse Events


  Other Adverse Events


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