Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Efavirenz or Atazanavir/Ritonavir Given With Emtricitabine/Tenofovir Disoproxil Fumarate or Abacavir/Lamivudine in HIV Infected Treatment-Naive Adults

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
AIDS Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT00118898
First received: July 7, 2005
Last updated: February 15, 2011
Last verified: February 2011
Results First Received: January 8, 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: Abacavir/Lamivudine
Drug: Atazanavir
Drug: Efavirenz
Drug: Emtricitabine/Tenofovir disoproxil fumarate
Drug: Ritonavir
Drug: Abacavir/Lamivudine placebo
Drug: Emtricitabine/Tenofovir disoproxil fumarate placebo

  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
Recruited at AIDS Clinical Trials Units in the United States and Puerto Rico. Recruitment occurred between September 21, 2005 (date first subject was randomized) and November 20, 2007 (date last subject was randomized).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
1864 were randomized. Results reported for 1857 eligible participants; 7 were subsequently found ineligible and excluded from all analyses.

Reporting Groups
  Description
EFV, FTC/TDF, and Placebo ABC/3TC Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
EFV, Placebo FTC/TDF, and ABC/3TC Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks

Participant Flow:   Overall Study
    EFV, FTC/TDF, and Placebo ABC/3TC     EFV, Placebo FTC/TDF, and ABC/3TC     RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC     RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC  
STARTED     464     465     465     463  
Initiated Treatment     461     461     464     462  
COMPLETED     343     324     342     322  
NOT COMPLETED     121     141     123     141  
Death                 6                 11                 6                 8  
Lost to Follow-up                 26                 34                 33                 33  
Withdrawal by Subject                 10                 5                 8                 8  
Site Closure                 33                 31                 28                 37  
Severe debilitation                 1                 4                 6                 4  
Not compliant with requirements                 11                 13                 11                 11  
Not able to get to clinic                 34                 43                 31                 40  



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

Reporting Groups
  Description
EFV, FTC/TDF, and Placebo ABC/3TC Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
EFV, Placebo FTC/TDF, and ABC/3TC Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
Total Total of all reporting groups

Baseline Measures
    EFV, FTC/TDF, and Placebo ABC/3TC     EFV, Placebo FTC/TDF, and ABC/3TC     RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC     RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC     Total  
Number of Participants  
[units: participants]
  464     465     465     463     1857  
Age  
[units: participants]
         
<=18 years     2     3     2     3     10  
Between 18 and 65 years     461     454     461     458     1834  
>=65 years     1     8     2     2     13  
Age  
[units: years]
Mean ± Standard Deviation
  38.2  ± 9.6     38.4  ± 10.5     38.9  ± 10.4     38.0  ± 9.8     38.4  ± 10.1  
Gender  
[units: participants]
         
Female     71     98     78     75     322  
Male     393     367     387     388     1535  
Race/Ethnicity, Customized [1]
[units: participants]
         
White Non-Hispanic     197     174     186     189     746  
Black Non-Hispanic     151     164     147     153     615  
Hispanic (Regardless of Race)     104     106     111     108     429  
Asian, Pacific Islander     5     8     12     7     32  
Native American, Alaskan Native     4     5     3     2     14  
More than One Race     2     5     5     4     16  
Unknown     1     3     1     0     5  
Region of Enrollment  
[units: participants]
         
United States     451     452     452     450     1805  
Puerto Rico     13     13     13     13     52  
Baseline HIV-1 RNA [2]
[units: log10 copies/mL]
Mean ± Standard Deviation
  4.7  ± 0.7     4.7  ± 0.7     4.7  ± 0.7     4.7  ± 0.7     4.7  ± 0.7  
Screening HIV-1 RNA  
[units: participants]
         
<100,000 copies/mL     265     266     265     264     1060  
>=100,000 copies/mL     199     199     200     199     797  
Baseline CD4+ count [3]
[units: cells/mm3]
Median ( Inter-Quartile Range )
  233.5  
  ( 102.5 to 333.5 )  
  225  
  ( 103 to 324 )  
  224  
  ( 87.0 to 326.5 )  
  236  
  ( 71.5 to 345.5 )  
  229.5  
  ( 89.5 to 333.8 )  
[1] Race/Ethnicity is collected prior to study entry, participants may opt out of reporting.
[2] Baseline RNA is calculated as the mean of the log10 pre-entry and entry values
[3] Baseline CD4 count is the average (mean) of 2 measures taken at pre-entry and entry visits.



  Outcome Measures
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1.  Primary:   Time From Randomization to Virologic Failure   [ Time Frame: Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details ]

Measure Type Primary
Measure Title Time From Randomization to Virologic Failure
Measure Description Blood samples for determining virologic failure were obtained at visit weeks 16 and 24 , and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks after randomization and before 24 weeks, or >=200 copies/mL at or after 24 weeks. The 5th percentile for time to virologic failure is the time (in weeks) at which 5% of the participants have experienced virologic failure.
Time Frame Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details  
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.
Intention to treat: All eligible participants were included in the analysis, participants were analyzed per originally assigned regimen.

Reporting Groups
  Description
EFV, FTC/TDF, and Placebo ABC/3TC Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
EFV, Placebo FTC/TDF, and ABC/3TC Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks

Measured Values
    EFV, FTC/TDF, and Placebo ABC/3TC     EFV, Placebo FTC/TDF, and ABC/3TC     RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC     RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC  
Number of Participants Analyzed  
[units: participants]
  464     465     465     463  
Time From Randomization to Virologic Failure  
[units: Weeks]
Number ( 95% Confidence Interval )
       
5th percentile time to virologic failure     36  
  ( 24 to 60 )  
  24  
  ( 16 to 24 )  
  24  
  ( 24 to 48 )  
  24  
  ( 16 to 24 )  
10th percentile time to virologic failure     96  
  ( 72 to 132 )  
  36  
  ( 24 to 60 )  
  84  
  ( 48 to 156 )  
  36  
  ( 24 to 60 )  

No statistical analysis provided for Time From Randomization to Virologic Failure



2.  Primary:   Time From Treatment Dispensation to a Grade 3/4 Safety Event   [ Time Frame: All follow-up while on initially assigned regimen; the median (25th, 75th percentile) follow-up while on initial regimen was 120 (54, 156) weeks and the range was 0 to 205 weeks. ]

Measure Type Primary
Measure Title Time From Treatment Dispensation to a Grade 3/4 Safety Event
Measure Description Grade 3/4 safety event is defined as a grade 3 or 4 sign, symptom, or laboratory abnormality that is at least one grade higher than at baseline, total bilirubin and creatine kinase (CPK) were excluded. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables.
Time Frame All follow-up while on initially assigned regimen; the median (25th, 75th percentile) follow-up while on initial regimen was 120 (54, 156) weeks and the range was 0 to 205 weeks.  
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.
As-treated: Participants who initiated treatment are included in this analysis. Follow-up while on initially assigned treatment is included in the at-risk period.

Reporting Groups
  Description
EFV, FTC/TDF, and Placebo ABC/3TC Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
EFV, Placebo FTC/TDF, and ABC/3TC Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks

Measured Values
    EFV, FTC/TDF, and Placebo ABC/3TC     EFV, Placebo FTC/TDF, and ABC/3TC     RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC     RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC  
Number of Participants Analyzed  
[units: participants]
  461     461     464     462  
Time From Treatment Dispensation to a Grade 3/4 Safety Event  
[units: Weeks]
Number ( 95% Confidence Interval )
       
5th percentile time to a grade 3/4 safety event     2.6  
  ( 1.6 to 4.3 )  
  1.3  
  ( 1.0 to 1.3 )  
  3.0  
  ( 1.3 to 4.9 )  
  1.3  
  ( 1.0 to 1.7 )  
10th percentile time to a grade 3/4 safety event     7.9  
  ( 4.3 to 13.0 )  
  2.0  
  ( 1.3 to 3.9 )  
  8.1  
  ( 5.1 to 17.9 )  
  3.9  
  ( 1.9 to 7.1 )  
25th percentile time to a grade 3/4 safety event     59.3  
  ( 41.7 to 91.7 )  
  16.0  
  ( 8.3 to 22.0 )  
  81.4  
  ( 47.9 to 111.3 )  
  44.4  
  ( 24.3 to 52.1 )  

No statistical analysis provided for Time From Treatment Dispensation to a Grade 3/4 Safety Event



3.  Primary:   Time From Treatment Dispensation to Treatment Modification   [ Time Frame: Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details ]

Measure Type Primary
Measure Title Time From Treatment Dispensation to Treatment Modification
Measure Description Treatment modification is defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution.
Time Frame Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details  
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 who initiated treatment are included in this analysis. Participants were analyzed per originally assigned regimen.

Reporting Groups
  Description
EFV, FTC/TDF, and Placebo ABC/3TC Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
EFV, Placebo FTC/TDF, and ABC/3TC Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks

Measured Values
    EFV, FTC/TDF, and Placebo ABC/3TC     EFV, Placebo FTC/TDF, and ABC/3TC     RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC     RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC  
Number of Participants Analyzed  
[units: participants]
  461     461     464     462  
Time From Treatment Dispensation to Treatment Modification  
[units: Weeks]
Number ( 95% Confidence Interval )
       
5th percentile time to treatment modification     3.4  
  ( 1.6 to 7.1 )  
  1.4  
  ( 1.3 to 1.6 )  
  7.9  
  ( 2.1 to 14.0 )  
  1.6  
  ( 1.3 to 2.4 )  
10th percentile time to treatment modification     15.0  
  ( 7.6 to 23.7 )  
  2.1  
  ( 1.6 to 4.1 )  
  24.9  
  ( 14.4 to 38.1 )  
  5.0  
  ( 2.6 to 12.6 )  
25th percentile time to treatment modification     83.7  
  ( 63.0 to 119.6 )  
  27.4  
  ( 21.7 to 34.9 )  
  108.9  
  ( 85.1 to 144.1 )  
  43.6  
  ( 30.3 to 56.0 )  

No statistical analysis provided for Time From Treatment Dispensation to Treatment Modification



4.  Secondary:   Time From Treatment Dispensation to Regimen Failure (First Occurrence of Virologic Failure or Treatment Modification)   [ Time Frame: Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details ]

Measure Type Secondary
Measure Title Time From Treatment Dispensation to Regimen Failure (First Occurrence of Virologic Failure or Treatment Modification)
Measure Description Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. Treatment modification was defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution.
Time Frame Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details  
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 who initiated treatment are included in this analysis. Participants were analyzed per originally assigned regimen.

Reporting Groups
  Description
EFV, FTC/TDF, and Placebo ABC/3TC Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
EFV, Placebo FTC/TDF, and ABC/3TC Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks

Measured Values
    EFV, FTC/TDF, and Placebo ABC/3TC     EFV, Placebo FTC/TDF, and ABC/3TC     RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC     RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC  
Number of Participants Analyzed  
[units: participants]
  461     461     464     462  
Time From Treatment Dispensation to Regimen Failure (First Occurrence of Virologic Failure or Treatment Modification)  
[units: Weeks]
Number ( 95% Confidence Interval )
       
5th percentile time to regimen failure     4  
  ( 4 to 4 )  
  4  
  ( 4 to 4 )  
  4  
  ( 4 to 16 )  
  4  
  ( 4 to 4 )  
10th percentile time to regimen failure     16  
  ( 4 to 16 )  
  4  
  ( 4 to 4 )  
  16  
  ( 16 to 24 )  
  4  
  ( 4 to 16 )  
25th percentile time to regimen failure     72  
  ( 48 to 96 )  
  24  
  ( 16 to 36 )  
  84  
  ( 60 to 108 )  
  36  
  ( 24 to 36 )  

No statistical analysis provided for Time From Treatment Dispensation to Regimen Failure (First Occurrence of Virologic Failure or Treatment Modification)



5.  Secondary:   The Number of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL   [ Time Frame: At Weeks 48 and 96 ]

Measure Type Secondary
Measure Title The Number of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL
Measure Description No text entered.
Time Frame At Weeks 48 and 96  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to treat: All participants with RNA data were included, complete-case approach.

Reporting Groups
  Description
EFV, FTC/TDF, and Placebo ABC/3TC Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
EFV, Placebo FTC/TDF, and ABC/3TC Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks

Measured Values
    EFV, FTC/TDF, and Placebo ABC/3TC     EFV, Placebo FTC/TDF, and ABC/3TC     RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC     RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC  
Number of Participants Analyzed  
[units: participants]
  464     465     465     463  
The Number of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL  
[units: Participants]
       
Number of Participants with RNA data at Week 48     415     400     416     411  
Number with HIV-1 RNA <50 copies/ml at Week 48     372     346     348     322  
Number of Participants with RNA data at Week 96     379     361     384     374  
Number with HIV-1 RNA <50 copies/ml at Week 96     345     328     345     317  

No statistical analysis provided for The Number of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL



6.  Secondary:   Number of Participants With HIV-1 RNA Levels Less Than 200 Copies/mL   [ Time Frame: At Weeks 48 and 96 ]

Measure Type Secondary
Measure Title Number of Participants With HIV-1 RNA Levels Less Than 200 Copies/mL
Measure Description No text entered.
Time Frame At Weeks 48 and 96  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to treat: All participants with RNA data were included, complete-case approach.

Reporting Groups
  Description
EFV, FTC/TDF, and Placebo ABC/3TC Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
EFV, Placebo FTC/TDF, and ABC/3TC Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks

Measured Values
    EFV, FTC/TDF, and Placebo ABC/3TC     EFV, Placebo FTC/TDF, and ABC/3TC     RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC     RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC  
Number of Participants Analyzed  
[units: participants]
  464     465     465     463  
Number of Participants With HIV-1 RNA Levels Less Than 200 Copies/mL  
[units: Participants]
       
Number of Participants with RNA data at Week 48     415     400     416     411  
Number with HIV-1 RNA <200 copies/ml at Week 48     398     377     391     372  
Number of Participants with RNA data at Week 96     379     361     384     374  
Number with HIV-1 RNA <200 copies/ml at Week 96     362     342     368     346  

No statistical analysis provided for Number of Participants With HIV-1 RNA Levels Less Than 200 Copies/mL



7.  Secondary:   Change in CD4 Count (Cells/mm3) From Baseline   [ Time Frame: At Weeks 48 and 96 ]

Measure Type Secondary
Measure Title Change in CD4 Count (Cells/mm3) From Baseline
Measure Description Change was calculated as the CD4 count at Week 48 (or at Week 96) minus the baseline CD4 count (mean of pre-entry and entry values).
Time Frame At Weeks 48 and 96  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to treat: All participants with CD4 data were included, complete-case approach.

Reporting Groups
  Description
EFV, FTC/TDF, and Placebo ABC/3TC Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
EFV, Placebo FTC/TDF, and ABC/3TC Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks

Measured Values
    EFV, FTC/TDF, and Placebo ABC/3TC     EFV, Placebo FTC/TDF, and ABC/3TC     RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC     RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC  
Number of Participants Analyzed  
[units: participants]
  464     465     465     463  
Change in CD4 Count (Cells/mm3) From Baseline  
[units: Cells/mm3]
Median ( Inter-Quartile Range )
       
Week 48     163  
  ( 96.5 to 250.0 )  
  188  
  ( 102.5 to 277.5 )  
  175  
  ( 108 to 290 )  
  177.5  
  ( 106.0 to 275.5 )  
Week 96     220.5  
  ( 134.5 to 323.5 )  
  250.5  
  ( 158.0 to 364.3 )  
  251.5  
  ( 165.5 to 362.5 )  
  250.3  
  ( 153.0 to 350.0 )  

No statistical analysis provided for Change in CD4 Count (Cells/mm3) From Baseline



8.  Secondary:   Number of Participants With Virologic Failure and Emergence of Major Resistance   [ Time Frame: Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details ]

Measure Type Secondary
Measure Title Number of Participants With Virologic Failure and Emergence of Major Resistance
Measure Description Emergence of resistant virus was assessed by genotypic testing performed at Stanford University for all participants who met criteria for virologic failure and retrospectively on baseline samples from these participants. Major mutations were defined by International AIDS Society-United States of America (2008), as well as T69D, L74I, G190C/E/Q/T/V for reverse transcriptase and L24I, F53L, I54V/A/T/S, G73C/S/T/A, N88D for protease.
Time Frame Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details  
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.
Intention to treat: All eligible participants are included. Participants were analyzed per originally assigned regimen.

Reporting Groups
  Description
EFV, FTC/TDF, and Placebo ABC/3TC Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
EFV, Placebo FTC/TDF, and ABC/3TC Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks

Measured Values
    EFV, FTC/TDF, and Placebo ABC/3TC     EFV, Placebo FTC/TDF, and ABC/3TC     RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC     RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC  
Number of Participants Analyzed  
[units: participants]
  464     465     465     463  
Number of Participants With Virologic Failure and Emergence of Major Resistance  
[units: participants]
  27     41     5     12  

No statistical analysis provided for Number of Participants With Virologic Failure and Emergence of Major Resistance



9.  Secondary:   Number of Participants Experiencing Certain Targeted Clinical Events, Including Death, AIDS-defining Illness, and HIV-1 Related Events.   [ Time Frame: Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details ]

Measure Type Secondary
Measure Title Number of Participants Experiencing Certain Targeted Clinical Events, Including Death, AIDS-defining Illness, and HIV-1 Related Events.
Measure Description

AIDS-defining illnesses were defined per CDC category C definition. HIV-1 related events were defined per CDC category B definition. Events underwent study chair review for classification. See link below for more details.

http://www.cdc.gov/mmwr/preview/mmwrhtml/00018871.htm

Time Frame Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details  
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.
Intention to treat: All eligible participants were included in the analysis, participants were analyzed per originally assigned regimen.

Reporting Groups
  Description
EFV, FTC/TDF, and Placebo ABC/3TC Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
EFV, Placebo FTC/TDF, and ABC/3TC Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks

Measured Values
    EFV, FTC/TDF, and Placebo ABC/3TC     EFV, Placebo FTC/TDF, and ABC/3TC     RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC     RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC  
Number of Participants Analyzed  
[units: participants]
  464     465     465     463  
Number of Participants Experiencing Certain Targeted Clinical Events, Including Death, AIDS-defining Illness, and HIV-1 Related Events.  
[units: Participants]
       
Death     6     11     6     8  
AIDS-defining illness     14     25     20     23  
HIV-1 relatated event     56     61     57     63  

No statistical analysis provided for Number of Participants Experiencing Certain Targeted Clinical Events, Including Death, AIDS-defining Illness, and HIV-1 Related Events.



10.  Secondary:   Change in Fasting Total Cholesterol Level From Baseline   [ Time Frame: At Weeks 48 and 96 ]

Measure Type Secondary
Measure Title Change in Fasting Total Cholesterol Level From Baseline
Measure Description Only fasting results are included. The protocol did not require that samples be collected fasting.
Time Frame At Weeks 48 and 96  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to treat: All participants with fasting lipids data were included, complete-case approach.

Reporting Groups
  Description
EFV, FTC/TDF, and Placebo ABC/3TC Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
EFV, Placebo FTC/TDF, and ABC/3TC Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks

Measured Values
    EFV, FTC/TDF, and Placebo ABC/3TC     EFV, Placebo FTC/TDF, and ABC/3TC     RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC     RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC  
Number of Participants Analyzed  
[units: participants]
  464     465     465     463  
Change in Fasting Total Cholesterol Level From Baseline  
[units: mg/dL]
Median ( Inter-Quartile Range )
       
Week 48     22  
  ( 2 to 43 )  
  35  
  ( 15.5 to 58 )  
  11  
  ( -9 to 36 )  
  30  
  ( 9 to 54 )  
Week 96     23  
  ( 2 to 41 )  
  33  
  ( 10 to 60 )  
  14  
  ( -6 to 39 )  
  25  
  ( 7 to 50 )  

No statistical analysis provided for Change in Fasting Total Cholesterol Level From Baseline



11.  Secondary:   Change in Fasting High-density Lipoprotein (HDL) Cholesterol Level From Baseline   [ Time Frame: At Weeks 48 and 96 ]

Measure Type Secondary
Measure Title Change in Fasting High-density Lipoprotein (HDL) Cholesterol Level From Baseline
Measure Description Only fasting results are included. The protocol did not require that samples be collected fasting.
Time Frame At Weeks 48 and 96  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to treat: All participants with fasting lipids data were included, complete-case approach.

Reporting Groups
  Description
EFV, FTC/TDF, and Placebo ABC/3TC Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
EFV, Placebo FTC/TDF, and ABC/3TC Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks

Measured Values
    EFV, FTC/TDF, and Placebo ABC/3TC     EFV, Placebo FTC/TDF, and ABC/3TC     RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC     RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC  
Number of Participants Analyzed  
[units: participants]
  464     465     465     463  
Change in Fasting High-density Lipoprotein (HDL) Cholesterol Level From Baseline  
[units: mg/dL]
Median ( Inter-Quartile Range )
       
Week 48     8  
  ( 3 to 15 )  
  10  
  ( 4 to 18 )  
  5  
  ( -2 to 10 )  
  8  
  ( 1 to 16 )  
Week 96     9  
  ( 2 to 16 )  
  11  
  ( 3.5 to 18.5 )  
  4  
  ( -1 to 11 )  
  7  
  ( 1 to 15 )  

No statistical analysis provided for Change in Fasting High-density Lipoprotein (HDL) Cholesterol Level From Baseline



12.  Secondary:   Change in Fasting Non-high Density Lipoprotein (Non-HDL) Cholesterol Level From Baseline   [ Time Frame: At Weeks 48 and 96 ]

Measure Type Secondary
Measure Title Change in Fasting Non-high Density Lipoprotein (Non-HDL) Cholesterol Level From Baseline
Measure Description Only fasting results are included. The protocol did not require that samples be collected fasting.
Time Frame At Weeks 48 and 96  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to treat: All participants with fasting lipids data were included, complete-case approach.

Reporting Groups
  Description
EFV, FTC/TDF, and Placebo ABC/3TC Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
EFV, Placebo FTC/TDF, and ABC/3TC Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks

Measured Values
    EFV, FTC/TDF, and Placebo ABC/3TC     EFV, Placebo FTC/TDF, and ABC/3TC     RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC     RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC  
Number of Participants Analyzed  
[units: participants]
  464     465     465     463  
Change in Fasting Non-high Density Lipoprotein (Non-HDL) Cholesterol Level From Baseline  
[units: mg/dL]
Median ( Inter-Quartile Range )
       
Week 48     14  
  ( -4.5 to 30.5 )  
  23  
  ( 3 to 47 )  
  8  
  ( -11 to 30 )  
  20  
  ( -1 to 42 )  
Week 96     13.5  
  ( -5.5 to 31.0 )  
  18  
  ( 0 to 45 )  
  10  
  ( -9.5 to 34.0 )  
  18  
  ( 2 to 43 )  

No statistical analysis provided for Change in Fasting Non-high Density Lipoprotein (Non-HDL) Cholesterol Level From Baseline



13.  Secondary:   Change in Fasting Triglyceride Level From Baseline   [ Time Frame: At Weeks 48 and 96 ]

Measure Type Secondary
Measure Title Change in Fasting Triglyceride Level From Baseline
Measure Description Only fasting results are included. The protocol did not require that samples be collected fasting.
Time Frame At Weeks 48 and 96  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to treat: All participants with fasting lipids data were included, complete-case approach.

Reporting Groups
  Description
EFV, FTC/TDF, and Placebo ABC/3TC Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
EFV, Placebo FTC/TDF, and ABC/3TC Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks

Measured Values
    EFV, FTC/TDF, and Placebo ABC/3TC     EFV, Placebo FTC/TDF, and ABC/3TC     RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC     RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC  
Number of Participants Analyzed  
[units: participants]
  464     465     465     463  
Change in Fasting Triglyceride Level From Baseline  
[units: mg/dL]
Median ( Inter-Quartile Range )
       
Week 48     10  
  ( -29 to 44 )  
  15  
  ( -20 to 65 )  
  14  
  ( -18 to 52 )  
  24  
  ( -12 to 80 )  
Week 96     9  
  ( -27 to 48 )  
  14  
  ( -22 to 54 )  
  11  
  ( -21 to 47 )  
  33  
  ( -9 to 78 )  

No statistical analysis provided for Change in Fasting Triglyceride Level From Baseline



14.  Other Pre-specified:   Amount of Study Follow-up   [ Time Frame: Follow-up time was variable, median follow-up was 138 weeks ]

Measure Type Other Pre-specified
Measure Title Amount of Study Follow-up
Measure Description Participants were to be followed for 96 weeks after the last enrollment. Accrual was expected to take 96 weeks, thus the planned follow-up time was 96 to 192 weeks, dependent on when in the study the participant enrolled. This outcome summarizes that total amount of actual follow-up in weeks from randomization to last contact.
Time Frame Follow-up time was variable, median follow-up was 138 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.
Intention to treat: All eligible participants are included. Participants were analyzed per originally assigned regimen.

Reporting Groups
  Description
EFV, FTC/TDF, and Placebo ABC/3TC Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
EFV, Placebo FTC/TDF, and ABC/3TC Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks

Measured Values
    EFV, FTC/TDF, and Placebo ABC/3TC     EFV, Placebo FTC/TDF, and ABC/3TC     RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC     RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC  
Number of Participants Analyzed  
[units: participants]
  464     465     465     463  
Amount of Study Follow-up  
[units: Weeks]
Median ( Inter-Quartile Range )
  141.4  
  ( 108 to 169 )  
  133.3  
  ( 101.3 to 168.0 )  
  141.6  
  ( 105.9 to 168.1 )  
  137.3  
  ( 106.0 to 169.1 )  

No statistical analysis provided for Amount of Study Follow-up



15.  Other Pre-specified:   Number of Participants With Virologic Failure   [ Time Frame: Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details ]

Measure Type Other Pre-specified
Measure Title Number of Participants With Virologic Failure
Measure Description Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks.
Time Frame Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details  
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.
Intention to treat: All eligible participants were included in the analysis, participants were analyzed per originally assigned regimen.

Reporting Groups
  Description
EFV, FTC/TDF, and Placebo ABC/3TC Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
EFV, Placebo FTC/TDF, and ABC/3TC Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks

Measured Values
    EFV, FTC/TDF, and Placebo ABC/3TC     EFV, Placebo FTC/TDF, and ABC/3TC     RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC     RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC  
Number of Participants Analyzed  
[units: participants]
  464     465     465     463  
Number of Participants With Virologic Failure  
[units: participants]
  57     72     57     83  

No statistical analysis provided for Number of Participants With Virologic Failure



16.  Other Pre-specified:   Cumulative Probability of Not Experiencing Virologic Failure   [ Time Frame: At week 48 and 96 ]

Measure Type Other Pre-specified
Measure Title Cumulative Probability of Not Experiencing Virologic Failure
Measure Description Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks.
Time Frame At week 48 and 96  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to treat: All eligible participants were included in the analysis, participants were analyzed per originally assigned regimen.

Reporting Groups
  Description
EFV, FTC/TDF, and Placebo ABC/3TC Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
EFV, Placebo FTC/TDF, and ABC/3TC Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks

Measured Values
    EFV, FTC/TDF, and Placebo ABC/3TC     EFV, Placebo FTC/TDF, and ABC/3TC     RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC     RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC  
Number of Participants Analyzed  
[units: participants]
  464     465     465     463  
Cumulative Probability of Not Experiencing Virologic Failure  
[units: percentage of participants]
Number ( 95% Confidence Interval )
       
Week 48     94  
  ( 91 to 96 )  
  88  
  ( 85 to 91 )  
  92  
  ( 89 to 94 )  
  88  
  ( 84 to 90 )  
Week 96     90  
  ( 87 to 92 )  
  85  
  ( 82 to 88 )  
  89  
  ( 86 to 92 )  
  83  
  ( 79 to 87 )  

No statistical analysis provided for Cumulative Probability of Not Experiencing Virologic Failure



17.  Other Pre-specified:   Number of Participants With a Grade 3/4 Safety Event   [ Time Frame: Over all study follow-up while on initially assigned treatment, median follow-up was 120 weeks ]

Measure Type Other Pre-specified
Measure Title Number of Participants With a Grade 3/4 Safety Event
Measure Description Grade 3/4 safety event is defined as a grade 3 or 4 sign, symptom, or laboratory abnormality that is at least one grade higher than at baseline, total bilirubin and creatine kinase (CPK) were excluded. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables. As-treated analysis censored at 1st modification of initially assigned regimen, participants who never started treatment were excluded.
Time Frame Over all study follow-up while on initially assigned treatment, median follow-up was 120 weeks  
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.
As-treated: Participants who initiated treatment are included in this analysis. Follow-up while on initially assigned treatment is included in the at-risk period.

Reporting Groups
  Description
EFV, FTC/TDF, and Placebo ABC/3TC Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
EFV, Placebo FTC/TDF, and ABC/3TC Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks

Measured Values
    EFV, FTC/TDF, and Placebo ABC/3TC     EFV, Placebo FTC/TDF, and ABC/3TC     RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC     RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC  
Number of Participants Analyzed  
[units: participants]
  461     461     464     462  
Number of Participants With a Grade 3/4 Safety Event  
[units: participants]
  145     182     137     156  

No statistical analysis provided for Number of Participants With a Grade 3/4 Safety Event



18.  Other Pre-specified:   Cumulative Probability of Not Experiencing a Grade 3/4 Safety Event   [ Time Frame: At week 48 and 96 ]

Measure Type Other Pre-specified
Measure Title Cumulative Probability of Not Experiencing a Grade 3/4 Safety Event
Measure Description Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Grade 3/4 safety event is defined as a grade 3 or 4 sign, symptom, or laboratory abnormality that is at least one grade higher than at baseline, total bilirubin and creatine kinase (CPK) were excluded. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables. As-treated analysis censored at 1st modification of initially assigned regimen, participants who never started treatment were excluded.
Time Frame At week 48 and 96  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As-treated: Participants who initiated treatment are included in this analysis. Follow-up while on initially assigned treatment is included in the at-risk period.

Reporting Groups
  Description
EFV, FTC/TDF, and Placebo ABC/3TC Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
EFV, Placebo FTC/TDF, and ABC/3TC Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks

Measured Values
    EFV, FTC/TDF, and Placebo ABC/3TC     EFV, Placebo FTC/TDF, and ABC/3TC     RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC     RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC  
Number of Participants Analyzed  
[units: participants]
  461     461     464     462  
Cumulative Probability of Not Experiencing a Grade 3/4 Safety Event  
[units: percentage of participants]
Number ( 95% Confidence Interval )
       
Week 48     78  
  ( 73 to 81 )  
  64  
  ( 60 to 69 )  
  79  
  ( 75 to 82 )  
  73  
  ( 68 to 77 )  
Week 96     70  
  ( 65 to 74 )  
  58  
  ( 53 to 63 )  
  73  
  ( 68 to 77 )  
  66  
  ( 61 to 70 )  

No statistical analysis provided for Cumulative Probability of Not Experiencing a Grade 3/4 Safety Event



19.  Other Pre-specified:   Number of Participants With Treatment Modification   [ Time Frame: Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details ]

Measure Type Other Pre-specified
Measure Title Number of Participants With Treatment Modification
Measure Description Treatment modification is defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution.
Time Frame Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details  
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 who initiated treatment are included in this analysis. Participants were analyzed per originally assigned regimen.

Reporting Groups
  Description
EFV, FTC/TDF, and Placebo ABC/3TC Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
EFV, Placebo FTC/TDF, and ABC/3TC Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks

Measured Values
    EFV, FTC/TDF, and Placebo ABC/3TC     EFV, Placebo FTC/TDF, and ABC/3TC     RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC     RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC  
Number of Participants Analyzed  
[units: participants]
  461     461     464     462  
Number of Participants With Treatment Modification  
[units: participants]
  152     239     138     216  

No statistical analysis provided for Number of Participants With Treatment Modification



20.  Other Pre-specified:   Cumulative Probability of Not Experiencing Treatment Modification   [ Time Frame: At week 48 and 96 ]

Measure Type Other Pre-specified
Measure Title Cumulative Probability of Not Experiencing Treatment Modification
Measure Description Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Treatment modification is defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution.
Time Frame At week 48 and 96  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who initiated treatment are included in this analysis. Participants were analyzed per originally assigned regimen.

Reporting Groups
  Description
EFV, FTC/TDF, and Placebo ABC/3TC Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
EFV, Placebo FTC/TDF, and ABC/3TC Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks

Measured Values
    EFV, FTC/TDF, and Placebo ABC/3TC     EFV, Placebo FTC/TDF, and ABC/3TC     RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC     RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC  
Number of Participants Analyzed  
[units: participants]
  461     461     464     462  
Cumulative Probability of Not Experiencing Treatment Modification  
[units: percentage of participants]
Number ( 95% Confidence Interval )
       
Week 48     80  
  ( 76 to 84 )  
  67  
  ( 63 to 71 )  
  86  
  ( 82 to 89 )  
  73  
  ( 69 to 77 )  
Week 96     73  
  ( 69 to 77 )  
  56  
  ( 52 to 61 )  
  77  
  ( 73 to 81 )  
  62  
  ( 58 to 66 )  

No statistical analysis provided for Cumulative Probability of Not Experiencing Treatment Modification



21.  Other Pre-specified:   Number of Participants With Regimen Failure   [ Time Frame: Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details ]

Measure Type Other Pre-specified
Measure Title Number of Participants With Regimen Failure
Measure Description Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. Treatment modification was defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution.
Time Frame Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details  
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 who initiated treatment are included in this analysis. Participants were analyzed per originally assigned regimen.

Reporting Groups
  Description
EFV, FTC/TDF, and Placebo ABC/3TC Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
EFV, Placebo FTC/TDF, and ABC/3TC Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks

Measured Values
    EFV, FTC/TDF, and Placebo ABC/3TC     EFV, Placebo FTC/TDF, and ABC/3TC     RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC     RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC  
Number of Participants Analyzed  
[units: participants]
  461     461     464     462  
Number of Participants With Regimen Failure  
[units: participants]
  162     246     157     233  

No statistical analysis provided for Number of Participants With Regimen Failure



22.  Other Pre-specified:   Cumulative Probability of Not Experiencing Regimen Failure   [ Time Frame: At week 48 and 96 ]

Measure Type Other Pre-specified
Measure Title Cumulative Probability of Not Experiencing Regimen Failure
Measure Description Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. Treatment modification was defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution.
Time Frame At week 48 and 96  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who initiated treatment are included in this analysis. Participants were analyzed per originally assigned regimen.

Reporting Groups
  Description
EFV, FTC/TDF, and Placebo ABC/3TC Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
EFV, Placebo FTC/TDF, and ABC/3TC Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks

Measured Values
    EFV, FTC/TDF, and Placebo ABC/3TC     EFV, Placebo FTC/TDF, and ABC/3TC     RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC     RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC  
Number of Participants Analyzed  
[units: participants]
  461     461     464     462  
Cumulative Probability of Not Experiencing Regimen Failure  
[units: percentage of participants]
Number ( 95% Confidence Interval )
       
Week 48     79  
  ( 75 to 82 )  
  64  
  ( 59 to 68 )  
  80  
  ( 76 to 84 )  
  66  
  ( 62 to 70 )  
Week 96     70  
  ( 66 to 74 )  
  54  
  ( 49 to 58 )  
  73  
  ( 69 to 77 )  
  57  
  ( 52 to 61 )  

No statistical analysis provided for Cumulative Probability of Not Experiencing Regimen Failure




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
HIV-1 drug resistance testing and HLA-B*5701 testing were not standard of care during enrollment. EFV and RTV-boosted ATV were open-label, and blinded FTC/TDF vs. ABC/3TC were unblinded in the >=100,000 cp/mL screening viral load stratum Feb 2008.


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