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A Phase 2, Randomized, Double-Blinded Study of the Safety and Efficacy of GS-9350-boosted Atazanavir Compared to Ritonavir-boosted Atazanavir in Combination With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00892437
First received: April 30, 2009
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);   Primary Purpose: Treatment
Condition: HIV-1 Infection
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
Participants were enrolled and treated in 32 study centers in the United States. The first participant was screened on 04 May 2009, and the last participant observation for the Week 96 analysis was 21 April 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
85 participants were randomized and 79 received at least one dose of study medication, and form 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), plus placebo to match ritonavir (RTV), plus atazanavir (ATV), plus emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) once daily.
ATV/r+FTC/TDF Participants were randomized to receive ritonavir, plus placebo to match COBI, plus ATV, plus FTC/TDF once daily.

Participant Flow for 2 periods

Period 1:   Randomized Period
    ATV/co+FTC/TDF     ATV/r+FTC/TDF  
STARTED     56     29  
Randomized and Treated     50     29  
COMPLETED     45     24  
NOT COMPLETED     11     5  
Randomized but not treated                 6                 0  
Adverse Event                 2                 2  
Lost to Follow-up                 1                 3  
Physician Decision                 1                 0  
Withdrawal by Subject                 1                 0  

Period 2:   Open-label Period (Through Week 96)
    ATV/co+FTC/TDF     ATV/r+FTC/TDF  
STARTED     44 [1]   19 [2]
COMPLETED     0     0  
NOT COMPLETED     44     19  
Adverse Event                 0                 1  
Death                 1                 0  
Lack of Efficacy                 1                 0  
Lost to Follow-up                 2                 0  
Participant Still on Study                 40                 18  
[1] 1 participant completed the randomized phase but did not enter the open-label extension phase.
[2] 5 participants completed the randomized phase but did not enter the open-label extension phase.



  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 one dose of study drug.

Reporting Groups
  Description
ATV/co+FTC/TDF Participants were randomized to receive COBI, placebo to match RTV, ATV, and FTC/TDF once daily.
ATV/r+FTC/TDF Participants were randomized to receive 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]
  50     29     79  
Age  
[units: years]
Mean ± Standard Deviation
  37  ± 9.6     34  ± 10.1     36  ± 9.8  
Gender  
[units: participants]
     
Female     3     4     7  
Male     47     25     72  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     7     5     12  
Not Hispanic or Latino     43     24     67  
Unknown or Not Reported     0     0     0  
Race/Ethnicity, Customized  
[units: participants]
     
Asian     0     2     2  
Black     18     9     27  
White     31     16     47  
Other     1     2     3  
HIV-1 RNA  
[units: log_10┬ácopies/mL]
Mean ± Standard Deviation
  4.56  ± 0.657     4.69  ± 0.530     4.61  ± 0.614  
HIV-1 RNA Category  
[units: participants]
     
≤ 100,000 copies/mL     38     18     56  
> 100,000 copies/mL     12     11     23  
Cluster of differentiation (CD4) Cell Count  
[units: cells/uL]
Mean ± Standard Deviation
  365  ± 201.3     343  ± 178.1     357  ± 192.2  
CD4 Cell Count Category  
[units: participants]
     
≤ 50 cells/μL     1     1     2  
51 to ≤ 200 cells/μL     9     6     15  
201 to ≤ 350 cells/μL     16     7     23  
351 to ≤ 500 cells/μL     17     11     28  
> 500 cells/μL     7     4     11  
HIV Disease Status  
[units: participants]
     
Asymptomatic     41     25     66  
Symptomatic HIV Infections     1     1     2  
AIDS     8     3     11  
Chronic Hepatitis B Infection Status  
[units: participants]
     
Negative     50     29     79  
Positive     0     0     0  
Chronic Hepatitis C Infection Status  
[units: participants]
     
Negative     50     29     79  
Positive     0     0     0  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24   [ Time Frame: Week 24 ]

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

3.  Secondary:   Change From Baseline in HIV-1 RNA at Week 24   [ Time Frame: Baseline to Week 24 ]

4.  Secondary:   Change From Baseline in HIV-1 RNA at Week 48   [ Time Frame: Baseline to Week 48 ]

5.  Secondary:   Change From Baseline in CD4 Cell Count at Week 24   [ Time Frame: Baseline to Week 24 ]

6.  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


Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT00892437     History of Changes
Other Study ID Numbers: GS-US-216-0105
Study First Received: April 30, 2009
Results First Received: October 23, 2014
Last Updated: October 23, 2014
Health Authority: United States: Food and Drug Administration