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


  Outcome Measures
  Show All Outcome Measures

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 ]

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. ]

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 ]

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 ]

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

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

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

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 ]

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 ]

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

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

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

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

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

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 ]

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

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 ]

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

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 ]

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

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 ]

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


  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.


  More Information