Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Standard of Care in Virologically Suppressed People With HIV-1

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.

NCT Number	NCT06630299
Lead Sponsor	Gilead Sciences Collaborators: Merck Sharp & Dohme LLC
Conditions	HIV-1-Infection
Enrollment	600 participants
Start Date	2024-10-08
Primary Completion	2026-04-23 (estimated)
Study Completion	2030-08 (estimated)
Updated on ClinicalTrials.gov	2026-05-29