The primary objective of this study is to evaluate the efficacy of switching from a regimen of either dolutegravir (DTG) and emtricitabine /tenofovir alafenamide (F/TAF) or DTG and emtricitabine/tenofovir disoproxil fumarate (F/TDF) to a fixed dose combination (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus DTG+F/TAF in virologically suppressed HIV-1 infected adults with or without antiretroviral (ARV) resistance.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
567
50/200/25 mg FDC tablet(s) administered orally once daily
200/25 mg FDC tablet(s) administered orally once daily
50 mg tablet(s) administered orally once daily
Tablet(s) administered orally once daily
Tablet(s) administered orally once daily
Tablet(s) administered orally once daily
Spectrum Medical Group
Phoenix, Arizona, United States
Ruane Clinical Research Group Inc.
Los Angeles, California, United States
Mills Clinical Research
Los Angeles, California, United States
Highland Hospital - Alameda Health System
Oakland, California, United States
Cares Community Health
Sacramento, California, United States
Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm
The percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant'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
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm
The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant'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 48
Time frame: Baseline; Week 48
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Kaiser Permanente
Sacramento, California, United States
Hepatitis/HIV Clinical Trials Group (HHCTG)
San Francisco, California, United States
Kaiser Permanente
San Francisco, California, United States
Kaiser Permanente, Department of Infectious Diseases
San Leandro, California, United States
University of Colorado Denver, University of Colorado Hospital
Aurora, Colorado, United States
...and 84 more locations