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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
StatusActive, Not Recruiting
PhasePhase 3
Started2024-10-09
View on ClinicalTrials.gov ↗

Amendment history

2026-04-28
minor
Study Status v13
Primary completion dateestimated 2026-04→confirmed 2026-04-17
2025-11-11
minor
Study Status, Sponsor/Collaborators v12
Collaborators+23 characters
Merck Sharp & Dohme LLC
2025-07-08
minor
Study Status v11
Primary completion date2026-06→2026-04
2025-05-27
notable
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v10
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 600→confirmed 609
Study sites106 entries, revised
Japan Institute for Health Security National Center for Global Health and Medicine
2025-03-31
minor
Study Status, Contacts/Locations v9
Study sites101→106
Show 8 earlier versions
2025-03-13
minor
Study Status, Contacts/Locations v8
Study sites93→101
2025-02-20
minor
Study Status, Contacts/Locations v7
Study sites77→93
2025-01-30
minor
Study Status, Contacts/Locations v6
Study sites76→77
2025-01-30
minor
Study Status, Contacts/Locations v5
Study sites63→76
2025-01-08
minor
Study Status, Contacts/Locations v4
Study sites53→63
2024-12-12
minor
Study Status, Contacts/Locations v3
Study sites25→53
2024-11-13
minor
Study Status, Contacts/Locations v2
Study sites12→25
2024-10-25
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations, References v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-10→confirmed 2024-10-09
Study sites0→12
2024-10-04
minor
Original filing
107 trials monitored
See 8 trials at risk
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.
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