The primary objective of this study is to evaluate the efficacy of switching to a fixed-dose combination (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing on a regimen consisting of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF), elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF), or atazanavir (ATV) + ritonavir (RTV) + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) in virologically suppressed HIV-1 infected women.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
472
150/150/200/10 mg FDC tablet administered orally once daily with food
150/150/200/300 mg FDC administered orally once daily with food
ATV 300 mg capsules administered orally once daily with food
RTV 100 mg tablets administered orally once daily with food
200/300 mg tablet administered orally once daily with food
50/200/25 mg FDC tablet administered orally once daily without regard to food
Unnamed facility
Stamford, Connecticut, United States
Unnamed facility
Washington D.C., District of Columbia, United States
Unnamed facility
Washington D.C., District of Columbia, United States
Unnamed facility
Fort Lauderdale, Florida, United States
Unnamed facility
Ft. Pierce, Florida, United States
Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Determined 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 Determined 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
Change From Baseline in CD4+ Cell Count at Week 48
Time frame: Baseline; Week 48
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Unnamed facility
Miami, Florida, United States
Unnamed facility
Miami, Florida, United States
Unnamed facility
Orlando, Florida, United States
Unnamed facility
Tampa, Florida, United States
Unnamed facility
Tampa, Florida, United States
...and 46 more locations