Safety and Efficacy of COBI-boosted Atazanavir Versus Ritonavir-boosted Atazanavir Each Administered With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01108510
First received: April 20, 2010
Last updated: April 15, 2016
Last verified: April 2016
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, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: HIV
HIV Infections
Interventions: Drug: COBI
Drug: RTV
Drug: ATV
Drug: FTC/TDF
Drug: COBI placebo
Drug: RTV placebo

  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
Participants were enrolled in a total of 144 study sites in Asia, Australia, Europe, and South and North America. The last study visit occurred on 17 April 2015.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
867 participants were screened.

Reporting Groups
  Description
ATV+COBI+FTC/TDF Cobicistat (COBI) 150 mg + ritonavir (RTV) placebo + atazanavir (ATV) 300 mg + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg) once daily
ATV+RTV+FTC/TDF RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily

Participant Flow:   Overall Study
    ATV+COBI+FTC/TDF     ATV+RTV+FTC/TDF  
STARTED     349     349  
COMPLETED     70     81  
NOT COMPLETED     279     268  
Randomized but Not Treated                 5                 1  
Joined Another Gilead-sponsored Study                 186                 195  
Adverse Event                 26                 19  
Lost to Follow-up                 20                 17  
Withdrew Consent                 21                 15  
Investigator’s Discretion                 12                 10  
Participant Noncompliance                 5                 7  
Lack of Efficacy                 3                 0  
Pregnancy                 0                 3  
Death                 1                 1  



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

Reporting Groups
  Description
ATV+COBI+FTC/TDF COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
ATV+RTV+FTC/TDF RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
Total Total of all reporting groups

Baseline Measures
    ATV+COBI+FTC/TDF     ATV+RTV+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     97     92     189  
Not Hispanic or Latino     245     253     498  
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: log10┬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/µL]
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:   Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96   [ Time Frame: Week 96 ]

3.  Secondary:   Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 144   [ Time Frame: Week 144 ]

4.  Secondary:   Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 192   [ Time Frame: Week 192 ]

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

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

7.  Secondary:   Change From Baseline in CD4 Cell Count at Week 144   [ Time Frame: Baseline to Week 144 ]

8.  Secondary:   Change From Baseline in CD4 Cell Count at Week 192   [ Time Frame: Baseline to Week 192 ]


  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
There were no limitations affecting the analysis or results.


  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


Publications of Results:

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01108510     History of Changes
Other Study ID Numbers: GS-US-216-0114
2009-016759-22 ( EudraCT Number )
Study First Received: April 20, 2010
Results First Received: October 23, 2014
Last Updated: April 15, 2016
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Austrian Medicines and Medical Devices Agency
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Brazil: National Health Surveillance Agency
Denmark: Danish Health and Medicines Authority
Dominican Republic: Dirección General de Drogas y Farmacias
Canada: Health Canada
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Germany: Federal Institute for Drugs and Medical Devices
Italy: The Italian Medicines Agency
Mexico: Federal Commission for Sanitary Risks Protection
Netherlands: Medicines Evaluation Board (MEB)
Portugal: INFARMED, National Authority of Medicines and Health Products, IP
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Switzerland: Swissmedic
Thailand: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency