Clinical Trial

Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed People With HIV-1

Study acronym: ISLEND-1
Active, Not Recruiting Phase 3
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Summary
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.
Protocol Amendment History 13 amendments
This ClinicalTrials.gov record has been amended 13 times since 2024-10-04; most recent amendment 2026-04-28.
Status change: Recruiting → Active, Not Recruiting 2025-05-27
Status change: Not Yet Recruiting → Recruiting 2024-10-25
Trial Details
NCT Number NCT06630286
Lead Sponsor Gilead Sciences
Collaborators: Merck Sharp & Dohme LLC
Conditions HIV-1-infection
Enrollment 609 participants
Start Date 2024-10-09
Primary Completion 2026-04-17 (estimated)
Study Completion 2030-08 (estimated)
Updated on ClinicalTrials.gov 2026-04-30