Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Stribild Versus Atripla in Human Immunodeficiency Virus, Type 1 (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:
NCT01095796
First received: March 17, 2010
Last updated: October 11, 2013
Last verified: October 2013
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.
No text entered.

Reporting Groups
  Description
Stribild Double-blind Stribild QD and placebo to match Atripla QHS
Atripla Double-blind Atripla QHS and placebo matching Stribild QD
Total Total of all reporting groups

Baseline Measures
    Stribild     Atripla     Total  
Number of Participants  
[units: participants]
  348     352     700  
Age  
[units: years]
Mean ± Standard Deviation
  38  ± 10.4     38  ± 10.6     38  ± 10.5  
Gender  
[units: participants]
     
Female     41     36     77  
Male     307     316     623  
Race/Ethnicity, Customized  
[units: participants]
     
American Indian or Alaska Native     2     4     6  
Asian     6     10     16  
Black or African Heritage     106     91     197  
Native Hawaiian or Pacific Islander     4     1     5  
White     214     227     441  
Other     16     19     35  
Region of Enrollment  
[units: participants]
     
United States     348     352     700  
HIV Disease Status  
[units: participants]
     
Asymptomatic     290     295     585  
Symptomatic HIV Infections     30     33     63  
AIDS     28     24     52  
Hepatitis B Virus (HBV) Infection Status  
[units: participants]
     
Negative     343     343     686  
Positive     5     9     14  
Hepatitis C Virus (HCV) Infection Status  
[units: participants]
     
Negative     331     337     668  
Positive     17     15     32  
HIV-1 RNA Category (copies/mL)  
[units: participants]
     
≤ 100,000     230     236     466  
> 100,000     118     116     234  
CD4 Cell Count (/µL)  
[units: participants]
     
≤ 50     7     6     13  
51 to ≤ 200     36     45     81  
201 to ≤ 350     112     96     208  
351 to ≤ 500     113     136     249  
> 500     80     69     149  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Percentage of Participants With Virologic Success Using the Food and Drug Administration (FDA)-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 Ribonucleic Acid (RNA) < 50 Copies/mL   [ Time Frame: Week 48 ]

2.  Secondary:   The Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 50 Copies/mL Using the FDA-defined Time to Loss of Virologic Response (TLOVR) Algorithm   [ Time Frame: Week 48 ]

3.  Secondary:   The Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 48   [ Time Frame: Baseline to Week 48 ]

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


  Serious Adverse Events


  Other Adverse Events


  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.


Limitations and Caveats
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
No text entered.  


Results Point of Contact:  
Name/Title: Christophe Beraud, Director, Regulatory Affairs
Organization: Gilead Sciences, Inc.
phone: (650) 522-5093
e-mail: christophe.beraud@gilead.com


Publications of Results:

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01095796     History of Changes
Other Study ID Numbers: GS-US-236-0102
Study First Received: March 17, 2010
Results First Received: September 20, 2012
Last Updated: October 11, 2013
Health Authority: United States: Food and Drug Administration