The goal of this clinical study is to learn more about the safety and efficacy of switching to a once weekly tablet of islatravir/lenacapavir (ISL/LEN) regimen versus continuing standard of care treatment in people with human immunodeficiency virus (PWH) who are virologically suppressed (HIV-1 RNA levels \< 50 copies/mL) on a stable standard of care regimen for ≥ 6 months prior to screening. The standard of care includes 2 or 3 medicines, antiretroviral agents (ARVs). The primary objective of the study is to evaluate the efficacy of switching to oral weekly ISL/LEN tablet regimen versus continuing standard of care in virologically suppressed PWH at Week 48.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
600
Tablet administered orally
2 or 3 antiretrovirals (ARVs) administered as defined by the investigator, according to the prescribing information.
University of Alabama at Birmingham(UAB) 1917 Research Clinic
Birmingham, Alabama, United States
Pueblo Family Physicians
Phoenix, Arizona, United States
Vv-Tmf-5366229
Los Angeles, California, United States
Ruane Clinical Research Group
Los Angeles, California, United States
BIOS Clinical Research
Palm Springs, 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 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 96 as Determined by the US FDA-defined Snapshot Algorithm
Time frame: Week 96
Change from Baseline in clusters of differentiation 4 (CD4) T-Cell Count at Week 48
Time frame: Baseline, Week 48
Change from Baseline in CD4 T-Cell Count at Week 96
Time frame: Baseline, Week 96
Proportion of Participants Discontinuing ISL/LEN due to Treatment-Emergent Adverse Events (TEAEs)
Time frame: First dose date up to Week 96
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