The primary objective of this study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) fixed-dose combination (FDC) versus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (Stribild®; E/C/F/TDF) FDC in HIV-1 infected, antiretroviral treatment-naive adults.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
279
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24
The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Time frame: Week 24
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48
The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Time frame: Week 48
Change From Baseline in log10 HIV-1 RNA at Weeks 24 and 48
Time frame: Baseline; Weeks 24 and 48
Change From Baseline in CD4+ Cell Count at Weeks 24 and 48
Time frame: Baseline; Weeks 24 and 48
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Tablet administered orally once daily
University of Alabama at Birmingham (UAB)
Birmingham, Alabama, United States
Spectrum Medical Group
Phoenix, Arizona, United States
AHF Research Center
Beverly Hills, California, United States
Kaiser Permanente
Los Angeles, California, United States
Peter J. Ruane, MD, Inc.
Los Angeles, California, United States
Anthony Mills MD, Inc
Los Angeles, California, United States
East Bay AIDS Center
Oakland, California, United States
St. Joseph Heritage Healthcare
Orange, California, United States
Stanford University
Palo Alto, California, United States
Kaiser Permanente Medical Group
Sacramento, California, United States
...and 31 more locations