Study of the Safety and Efficacy of Stribild Versus Atripla in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults
The objective of this double-blinded, multicenter, randomized, active-controlled study is to evaluate the safety and efficacy of Stribild, a single-tablet regimen (STR) containing fixed doses of elvitegravir (EVG)/GS-9350 (cobicistat; COBI)/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) versus efavirenz (EFV)/FTC/TDF (Atripla) in HIV-1 infected, antiretroviral treatment-naive adult participants. Stribild offers an alternative STR for patients who are not candidates for non-nucleoside reverse transcriptor (NNRTI)-based STRs.
Participants will be randomized in a 2:1 ratio to receive Stribild or Atripla. Randomization will be stratified by HIV-1 RNA level (≤ 100,000 copies/mL or > 100,000 copies/mL) at screening. After Week 48, participants will continue to take their blinded study drug and attend visits every 12 weeks until treatment assignments are unblinded (Week 60), at which point all participants will attend an Unblinding Visit and be given the option to participate in an open-label rollover extension (the extension is scheduled to be open until Stribild becomes commercially available, or until Gilead Sciences elects to terminate the study).
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Phase 2, Randomized, Double-Blinded Study of the Safety and Efficacy of Elvitegravir/Emtricitabine/Tenofovir Disoproxil Fumarate/GS-9350 Versus Atripla® (Efavirenz 600 mg/Emtricitabine 200 mg/Tenofovir Disoproxil Fumarate 300 mg) in HIV-1 Infected, Antiretroviral Treatment-Naive Adults|
- The Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) Less Than 50 Copies/mL at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]The percentage of participants with plasma HIV-1 RNA < 50 copies/mL at Week 24 was summarized.
- The Percentage of Participants With HIV-1 RNA Less Than 50 Copies/mL at Week 48 [ Time Frame: Week 48 ] [ Designated as safety issue: No ]The percentage of participants with plasma HIV-1 RNA < 50 copies/mL at Week 48 was summarized.
- Change From Baseline in HIV-1 RNA (log_10 Copies/mL) [ Time Frame: Baseline to Weeks 24 and 48 ] [ Designated as safety issue: No ]Change = Week 24 or 48 value minus baseline value
- Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 24 [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]Change = Week 24 value minus baseline value
- Change From Baseline in CD4 Cell Count at Week 48 [ Time Frame: Baseline to Week 48 ] [ Designated as safety issue: No ]Change = Week 48 value minus baseline value
- 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 ] [ Designated as safety issue: No ]The percentage of participants with virologic success at Weeks 24 and 48 assessed using the FDA-defined snapshot analysis for an HIV-1 RNA cutoff of 50 copies/mL was summarized.
|Study Start Date:||April 2009|
|Study Completion Date:||September 2013|
|Primary Completion Date:||November 2009 (Final data collection date for primary outcome measure)|
Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily (QD) + placebo to match Atripla once daily prior to bedtime (QHS)
|Active Comparator: Atripla||
Atripla (EFV 150 mg/FTC 200mg/TDF 300 mg) STR QHS + placebo to match Stribild QD
Please refer to this study by its ClinicalTrials.gov identifier: NCT00869557
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