The primary objective of this study is to evaluate the efficacy of switching from a regimen of dolutegravir (DTG) and abacavir/lamivudine (ABC/3TC) or a fixed dose combination (FDC) of abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) to a FDC of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing DTG and ABC/3TC as the FDC ABC/DTG/3TC in virologically suppressed Human Immunodeficiency Virus- 1 (HIV-1) infected adults.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
567
600/50/300 mg FDC tablets administered orally once daily without regard to food
50/200/25 mg FDC tablets administered orally once daily without regard to food
Tablets administered orally once daily without regard to food
Percentage of Participants With Virologic Failure (HIV-1 RNA ≥ 50 Copies/mL) as Defined by the Modified 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
Percentage of Participants With HIV-1 RNA < 50 Copies/mL 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
Spine Bone Mineral Density (BMD) at Baseline
Time frame: Baseline
Percentage Change From Baseline in Spine BMD at Week 48
Time frame: Baseline; Week 48
Hip Bone Mineral Density at Baseline
Time frame: Baseline
Percentage Change From Baseline in Hip BMD at Week 48
Time frame: Baseline; Week 48
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Tablets administered orally once daily without regard to food
Unnamed facility
Phoenix, Arizona, United States
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Beverly Hills, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Oakland, California, United States
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Oakland, California, United States
Unnamed facility
Palm Springs, California, United States
Unnamed facility
Sacramento, California, United States
...and 84 more locations