This study is to evaluate the safety and efficacy darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed dose combination (FDC) tablet versus darunavir (DRV)+cobicistat (COBI)+emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) in HIV-1 infected, antiretroviral treatment-naive adults as determined by the achievement of HIV-1 RNA \< 50 copies/mL at Week 24.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
153
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24
The snapshot algorithm was used 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 snapshot algorithm was used 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 HIV-1 RNA at Week 24
Time frame: Baseline; Week 24
Change From Baseline in HIV-1 RNA at Week 48
Time frame: Baseline; Week 48
Change From Baseline in CD4+ Cell Count at Week 24
Time frame: Baseline; Week 24
Change From Baseline in CD4+ Cell Count at Week 48
Time frame: Baseline; Week 48
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FTC 200 mg/TDF 300 mg FDC tablet administered orally once daily
D/C/F/TAF placebo tablet administered orally once daily
DRV placebo tablet administered orally once daily
COBI placebo tablet administered orally once daily
FTC/TDF placebo tablet administered orally once daily
University of Alabama at Birmingham
Birmingham, Alabama, 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
Orange Coast Medical Group
Newport Beach, California, United States
Alta Bates Summit Medical Center, East Bay AIDS Center
Oakland, California, United States
Stanford University
Palo Alto, California, United States
Kaiser Permanente Medical Group
Sacramento, California, United States
La Playa Medical Group and Clinical Research
San Diego, California, United States
...and 34 more locations