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Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of COBI-boosted Atazanavir Versus Ritonavir-boosted Atazanavir Each Administered With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naïve Adults

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01108510
First received: April 20, 2010
Last updated: October 23, 2014
Last verified: October 2014
Results First Received: October 23, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: HIV
HIV Infections
Interventions: Drug: Cobicistat
Drug: Ritonavir
Drug: Atazanavir
Drug: FTC/TDF
Drug: Placebo to match COBI
Drug: Placebo to match RTV

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were enrolled in a total of 143 study sites in Asia, Australia, Europe, and North America. The first participant was screened on 26 April 2010. The last participant observation for the Week 48 analysis was on 29 November 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
867 participants were screened and 698 were randomized; 692 participants were treated and comprise the Safety Analysis Set and the Intent-to-Treat (ITT) Analysis Set.

Reporting Groups
  Description
ATV/co+FTC/TDF Participants were randomized to receive cobicistat (COBI) 150 mg, plus placebo to match ritonavir (RTV), plus atazanavir (ATV) 300 mg, plus emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg once daily.
ATV/r+FTC/TDF Participants were randomized to receive RTV 100 mg, plus placebo to match COBI, plus ATV 300 mg, plus FTC 200 mg/TDF 300 mg once daily.

Participant Flow:   Overall Study
    ATV/co+FTC/TDF     ATV/r+FTC/TDF  
STARTED     349     349  
Randomized and Treated     344     348  
COMPLETED     0     0  
NOT COMPLETED     349     349  
Randomized but not treated                 5                 1  
Adverse Event                 13                 9  
Pregnancy                 0                 2  
Lack of Efficacy                 1                 0  
Physician Decision                 2                 1  
Withdrawal by Subject                 3                 3  
Lost to Follow-up                 13                 4  
Participant noncompliance                 2                 2  
Participant still on study                 310                 327  



  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.
ITT Analysis Set: participants who were randomized and received at least on dose of study drug.

Reporting Groups
  Description
ATV/co+FTC/TDF Participants received COBI, placebo to match RTV, ATV, and FTC/TDF once daily
ATV/r+FTC/TDF Participants received RTV, placebo to match COBI, ATV, and FTC/TDF once daily
Total Total of all reporting groups

Baseline Measures
    ATV/co+FTC/TDF     ATV/r+FTC/TDF     Total  
Number of Participants  
[units: participants]
  344     348     692  
Age  
[units: years]
Mean ± Standard Deviation
  37  ± 9.8     38  ± 9.6     37  ± 9.7  
Gender  
[units: participants]
     
Female     57     61     118  
Male     287     287     574  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     98     92     190  
Not Hispanic or Latino     244     253     497  
Unknown or Not Reported     2     3     5  
Race/Ethnicity, Customized  
[units: participants]
     
American Indian or Alaska Native     1     2     3  
Asian     44     37     81  
Black or African Heritage     65     63     128  
Native Hawaiian or Pacific Islander     1     1     2  
White     198     215     413  
Not Permitted     2     3     5  
Other     33     27     60  
Region of Enrollment [1]
[units: participants]
     
Australia     7     8     15  
Austria     13     5     18  
Belgium     7     11     18  
Brazil     18     17     35  
Canada     26     18     44  
Denmark     0     2     2  
Dominican Republic     27     31     58  
France     12     19     31  
Germany     17     21     38  
Italy     6     15     21  
Mexico     18     17     35  
Netherlands     0     1     1  
Portugal     9     5     14  
Spain     3     4     7  
Switzerland     3     12     15  
Thailand     35     31     66  
United Kingdom     14     18     32  
United States     134     114     248  
HIV-1 RNA  
[units: log_10┬ácopies/mL]
Mean ± Standard Deviation
  4.81  ± 0.585     4.84  ± 0.594     4.83  ± 0.589  
HIV-1 RNA Category  
[units: participants]
     
≤ 100,000 copies/mL     212     205     417  
> 100,000 copies/mL     132     143     275  
Cluster of differentiation (CD4) Cell Count  
[units: cells/uL]
Mean ± Standard Deviation
  353  ± 170.5     351  ± 175.5     352  ± 172.9  
CD4 Cell Count Category  
[units: participants]
     
≤ 50 cells/μL     11     12     23  
51 to ≤ 200 cells/μL     49     45     94  
201 to ≤ 350 cells/μL     114     126     240  
351 to ≤ 500 cells/μL     123     117     240  
> 500 cells/μL     47     48     95  
HIV Disease Status  
[units: participants]
     
Asymptomatic     285     292     577  
Symptomatic HIV Infections     31     32     63  
AIDS     28     24     52  
Hepatitis B Surface Antigen Status  
[units: participants]
     
Positive     16     9     25  
Negative     328     339     667  
Hepatitis C Antibody Status  
[units: participants]
     
Positive     21     16     37  
Negative     323     331     654  
Indeterminate     0     1     1  
[1] All randomized participants were analyzed for Region of Enrollment (n = 349 per group)



  Outcome Measures
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1.  Primary:   Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48   [ Time Frame: Week 48 ]

2.  Secondary:   Change From Baseline in CD4 Cell Count at Week 48   [ Time Frame: Baseline to 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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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Clinical Trial Disclosures
Organization: Gilead Sciences, Inc.
e-mail: ClinicalTrialDisclosures@gilead.com


No publications provided by Gilead Sciences

Publications automatically indexed to this study:

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01108510     History of Changes
Other Study ID Numbers: GS-US-216-0114
Study First Received: April 20, 2010
Results First Received: October 23, 2014
Last Updated: October 23, 2014
Health Authority: United States: Food and Drug Administration