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: April 16, 2014
Last verified: April 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
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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 at 97 sites in the United States and 5 sites in Puerto Rico. The first participant was screened on 16 March 2010. The last participant observation for the Week 48 analysis was on 10 August 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
917 participants were screened; 707 were randomized (353 to the Stribild group and 354 to the Atripla group) of which 66.5% (470) had screening HIV-1 ribonucleic acid (RNA) ≤ 100,000 copies/mL. A total of 700 randomized participants received at least 1 dose of study medication and comprised the safety and intent-to treat (ITT) analysis sets.

Reporting Groups
  Description
Stribild Double-blind Stribild (elvitegravir [EVG] 150 mg/GS-9350 [cobicistat; COBI] 150 mg/emtricitabine [FTC] 200 mg/tenofovir disoproxil fumarate [TDF] 300 mg) once daily (QD) and placebo to match Atripla once daily prior to bedtime (QHS)
Atripla Double-blind Atripla (efavirenz [EFV] 150 mg/FTC 200 mg/TDF 300 mg) QHS and placebo to match Stribild QD

Participant Flow:   Overall Study
    Stribild     Atripla  
STARTED     348     352  
COMPLETED     0     0  
NOT COMPLETED     348     352  
Adverse Event                 12                 18  
Death                 1                 1  
Pregnancy                 1                 0  
Lack of Efficacy                 5                 4  
Physician Decision                 1                 0  
Withdrawal by Subject                 3                 5  
Lost to Follow-up                 10                 12  
Participant Noncompliance                 3                 6  
Protocol Violation                 1                 0  
Subjects Still on Study Treatment                 311                 306  



  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
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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 ]
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Measure Type Secondary
Measure Title The Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 48
Measure Description Change = Week 48 value minus baseline value
Time Frame Baseline to Week 48  
Safety Issue No  

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. The missing = excluded (M = E) method was used in which all participants with missing data were excluded from analysis.

Reporting Groups
  Description
Stribild Double-blind Stribild QD and placebo to match Atripla QHS
Atripla Double-blind Atripla QHS and placebo matching Stribild QD

Measured Values
    Stribild     Atripla  
Number of Participants Analyzed  
[units: participants]
  325     315  
The Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 48  
[units: cells/µL]
Mean ± Standard Deviation
  239  ± 167.2     206  ± 153.4  

No statistical analysis provided for The Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at 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


  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