The primary objective of this study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed dose combination (FDC) plus darunavir (DRV) relative to current antiretroviral regimens (ARV) in virologically suppressed, HIV-1 positive participants with HIV-1 RNA \<50 copies/mL at Week 24. This study consists of 48 weeks of open-label phase followed by an optional Extension Phase in which all the participants will receive E/C/F/TAF+DRV.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
158
150/150/200/10 mg FDC tablet administered orally once daily
800 mg tablet administered orally once daily
Participants will take their baseline DRV- containing ARV regimen as prescribed.
Pueblo Family Physicians, Ltd.
Phoenix, Arizona, United States
Pacific Oaks Medical Group
Beverly Hills, California, United States
Kaiser Permanente
Hayward, California, United States
Long Beach Education and Research Consultants
Long Beach, California, United States
Peter J Ruane, MD, Inc.
Los Angeles, California, United States
Percentage of Participants in Each Treatment Arm in Cohort 2 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 in Each Treatment Arm in Cohort 2 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 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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Kaiser Permanente Medical Group
Sacramento, California, United States
Kaiser San Francisco Division of Research
San Francisco, California, United States
Dupont Circle Physician's Group
Washington D.C., District of Columbia, United States
Midland Florida Clinical Research Center, LLC
DeLand, Florida, United States
Therafirst Medical Center
Fort Lauderdale, Florida, United States
...and 52 more locations