The goal of this clinical study is to learn more about the effects of switching to the study drugs, bictegravir (BIC)/lenacapavir (LEN), fixed-dose combination (FDC) versus current therapy bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) FDC in people living with HIV-1 (PWH). The primary objective of this study is to learn how effective it is to switch to BIC/LEN FDC tablets versus continuing on B/F/TAF FDC tablets in virologically suppressed PWH.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
577
Tablets administered orally without regard to food
Tablets administered orally without regard to food
Tablets administered orally without regard to food
Proportion of Participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm
Time frame: Week 48
Proportion of Participants with HIV-1 RNA < 50 copies/mL at Week 48 as Determined by the US FDA-defined Snapshot Algorithm
Time frame: Week 48
Change From Baseline in Clusters of Differentiation 4 (CD4) Cell Count at Week 48
Time frame: Baseline; Week 48
Treatment Group 1: Proportion of Participants with HIV-1 RNA ≥ 50 copies/mL at Week 96 as Determined by the US FDA-defined Snapshot Algorithm
Time frame: Week 96
Treatment Group 1: Proportion of Participants with HIV-1 RNA < 50 copies/mL at Week 96 as Determined by US FDA-defined Snapshot Algorithm
Time frame: Week 96
Treatment Group 1: Change from Baseline in CD4 Cell Count at Week 96
Time frame: Baseline; Week 96
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) through Week 48
Time frame: From first dose date up to Week 48
Treatment Group 1: Percentage of Participants Experiencing Treatment-Emergent AEs through Week 96
Time frame: From first dose date up to Week 96
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Tablets administered orally without regard to food
Tablets administered orally without regard to food
Pueblo Family Physicians
Phoenix, Arizona, United States
Be Well Medical Center
Berkeley, California, United States
Pacific Oaks Medical Group
Beverly Hills, California, United States
Ruane Clinical Research Group Inc.
Los Angeles, California, United States
Alta Bates Summit Medical Center, Summit Campus, East Bay Advanced Care
Oakland, California, United States
BIOS Clinical Research
Palm Springs, California, United States
UCSD Anti Viral Research Centre (AVRC)
San Diego, California, United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, United States
Mills Clinical Research
West Hollywood, California, United States
Public Health Institute at Denver Health
Denver, Colorado, United States
...and 94 more locations