The goal of this clinical study is to learn about the safety and efficacy of switching to once weekly tablet of islatravir/lenacapavir (ISL/LEN) regimen versus continuing standard treatment of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in people with human immunodeficiency virus (PWH) who are virologically suppressed (HIV-1 RNA levels \< 50 copies/mL) on B/F/TAF for ≥ 6 months prior to screening. The primary objective is to evaluate the efficacy of switching to oral weekly ISL/LEN tablet regimen versus continuing B/F/TAF in virologically suppressed PWH at Week 48.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
609
Tablet administered orally
Tablet administered orally
Tablet administered orally
Tablet administered orally
University of Alabama at Birmingham
Birmingham, Alabama, United States
Pueblo Family Physicians
Phoenix, Arizona, United States
Kaiser Permanente Southern California
Los Angeles, California, United States
Ruane Clinical Research Group, Inc
Los Angeles, California, United States
Mills Clinical Research
Los Angeles, California, United States
Proportion of Participants with HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Determined by the United States (US) Food and Drug Administration (FDA)-Defined Snapshot Algorithm
Time frame: Week 48
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
Proportion of Participants with HIV-1 RNA < 50 Copies/mL at Weeks 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 Weeks 96 as Determined by the US FDA-Defined Snapshot Algorithm
Time frame: Week 96
Change From Baseline in Cluster of Differentiation 4 (CD4) T-Cell Count at Weeks 48
Time frame: Week 48
Change From Baseline in CD4 T-Cell Count at Weeks 96
Time frame: Week 96
Proportion of Participants Discontinuing ISL/LEN due to Treatment-Emergent Adverse Events (TEAEs)
Time frame: Day 1 up to Week 48
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