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Study of the Safety and Efficacy of Stribild Versus Atripla in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00869557
First received: March 24, 2009
Last updated: May 22, 2014
Last verified: May 2014
Results First Received: September 20, 2012  
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: Stribild
Drug: Atripla

  Participant Flow


  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 were randomized and received at least 1 dose of study medication.

Reporting Groups
  Description
Stribild Stribild QD and placebo to match Atripla QHS were administered during the double-blind phase. Stribild QD was administered during the extension phase.
Atripla Atripla QHS and placebo to match Stribild QD were administered during the double blind phase. Stribild QD was administered during the extension phase.
Total Total of all reporting groups

Baseline Measures
    Stribild     Atripla     Total  
Number of Participants  
[units: participants]
  48     23     71  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     48     23     71  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  36  ± 8.9     35  ± 9.6     36  ± 9.1  
Gender  
[units: participants]
     
Female     4     2     6  
Male     44     21     65  
Race/Ethnicity, Customized  
[units: participants]
     
American Indian or Alaska Native     1     0     1  
Asian     1     0     1  
Black     12     5     17  
White     33     18     51  
Other     1     0     1  
Region of Enrollment  
[units: participants]
     
United States     48     23     71  
HIV Disease Status  
[units: participants]
     
Asymptomatic     40     22     62  
Symptomatic HIV Infections     5     0     5  
AIDS     3     1     4  
Hepatitis B Virus (HBV) Infection Status  
[units: participants]
     
Negative     48     23     71  
Positive     0     0     0  
Hepatitis C Virus (HCV) Infection Status  
[units: participants]
     
Negative     48     23     71  
Positive     0     0     0  
HIV-1 RNA Category (copies/mL)  
[units: participants]
     
≤ 100,000     37     18     55  
> 100,000     11     5     16  
Cluster Determinant 4 (CD4) Cell Count (/µL)  
[units: participants]
     
≤ 50     0     0     0  
51 to ≤ 200     7     0     7  
201 to ≤ 350     17     8     25  
351 to ≤ 500     14     5     19  
> 500     10     10     20  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) Less Than 50 Copies/mL at Week 24   [ Time Frame: Week 24 ]

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

3.  Secondary:   Change From Baseline in HIV-1 RNA (log_10 Copies/mL)   [ Time Frame: Baseline to Weeks 24 and 48 ]

4.  Secondary:   Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 24   [ Time Frame: Baseline to Week 24 ]

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

6.  Secondary:   The Percentage of Participants With Virologic Success at Weeks 24 and 48 Using FDA-Defined Snapshot Analysis and HIV-1 RNA Less Than 50 Copies/mL   [ Time Frame: Baseline to Weeks 24 and 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


Publications of Results:

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT00869557     History of Changes
Other Study ID Numbers: GS-US-236-0104
Study First Received: March 24, 2009
Results First Received: September 20, 2012
Last Updated: May 22, 2014
Health Authority: United States: Food and Drug Administration