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

Study acronym: ISLEND-2
StatusActive, Not Recruiting
PhasePhase 3
Started2024-10-08
View on ClinicalTrials.gov ↗

Amendment history

2026-05-27
minor
Study Status v11
Primary completion dateestimated 2026-04→confirmed 2026-04-23
2025-11-12
minor
Study Status, Sponsor/Collaborators v10
Collaborators+23 characters
Merck Sharp & Dohme LLC
2025-07-09
minor
Study Status v9
Primary completion date2027-06→2026-04
2025-05-16
notable
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v8
Trial statusRecruiting→Active, Not Recruiting
Study sites99→100
2025-04-16
minor
Study Status, Contacts/Locations v7
Study sites91→99
Show 6 earlier versions
2025-03-19
minor
Study Status, Contacts/Locations v6
Study sites87→91
2025-02-27
minor
Study Status, Contacts/Locations v5
Study sites72→87
2025-02-04
minor
Study Status, Contacts/Locations v4
Study sites50→72
2025-01-15
minor
Study Status, Contacts/Locations v3
Study sites38→50
2024-12-12
minor
Study Status, Contacts/Locations v2
Study sites10→38
2024-10-30
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations, References v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-10→confirmed 2024-10-08
Study sites0→10
2024-10-04
minor
Original filing
107 trials monitored
See 8 trials at risk
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.
Trial Details
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