Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01095796
First received: March 17, 2010
Last updated: October 23, 2014
Last verified: October 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
  Hide Baseline Characteristics

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 one dose of study medication.

Reporting Groups
  Description
Stribild Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily plus placebo to match Atripla once daily prior to bedtime
Atripla Atripla (EFV 600 mg/FTC 200 mg/TDF 300 mg) tablet once daily prior to bedtime plus placebo to match Stribild
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 at Week 48   [ Time Frame: Week 48 ]

2.  Secondary:   The Percentage of Participants With Virologic Success Using the FDA-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 RNA < 50 Copies/mL at Week 96   [ Time Frame: Week 96 ]

3.  Secondary:   The Percentage of Participants With Virologic Success Using the FDA-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 RNA < 50 Copies/mL at Week 144   [ Time Frame: Week 144 ]

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

5.  Secondary:   The Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Weeks 48, 96 and 144   [ Time Frame: Baseline; Weeks 48, 96, and 144 ]

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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.


  More Information