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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
71
Health for Life Clinic, PLLC
Little Rock, Arkansas, United States
The Living Hope Foundation
Long Beach, California, United States
Peter J. Ruane, MD, Inc.
Los Angeles, California, United States
Orange Coast Medical Group
Newport Beach, California, United States
East Bay AIDS Center
Oakland, California, United States
The Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) Less Than 50 Copies/mL at Week 24
The percentage of participants with plasma HIV-1 RNA \< 50 copies/mL at Week 24 was summarized.
Time frame: Week 24
The Percentage of Participants With HIV-1 RNA Less Than 50 Copies/mL at Week 48
The percentage of participants with plasma HIV-1 RNA \< 50 copies/mL at Week 48 was summarized.
Time frame: Week 48
Change From Baseline in HIV-1 RNA (log_10 Copies/mL)
Change = Week 24 or 48 value minus baseline value
Time frame: Baseline to Weeks 24 and 48
Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 24
Change = Week 24 value minus baseline value
Time frame: Baseline to Week 24
Change From Baseline in CD4 Cell Count at Week 48
Change = Week 48 value minus baseline value
Time frame: Baseline to Week 48
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
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.
Time frame: Baseline to Weeks 24 and 48
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