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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
Overall Participants Analyzed 
[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 
[1] All randomized participants were analyzed for Region of Enrollment (n = 349 per group)
HIV-1 RNA 
[Units: Log10 copies/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 


  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