STATUS Recruitment Complete

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

Gilead Clinical Study Information Center:
Monday – Friday, 5am – 6pm PT
Email: [email protected]

STATUS

Recruitment Complete

GILEAD STUDY ID

GS-US-563-5925

Gilead Clinical Study Information Center:
Monday – Friday, 5am – 6pm PT
Email: [email protected]

LAST UPDATED

April 30, 2026

Clinicaltrials.gov ID

NCT06630286

CTSID

2024-514046-37

OVERVIEW

A Phase 3, Randomized, Double-blind, Active-controlled Study to Evaluate a Switch to an Oral Weekly Islatravir/Lenacapavir Regimen in People With HIV-1 Who Are Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) (ISLEND-1)

PROTOCOL 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.

Participation requirements

Age

18 years +

Sex

All

Healthy Volunteers

Study details

Medical Condition

HIV-1-infection

Gender

N/A

Date

October 2024 - April 2026

Study Type

Interventional

Study Phase

Phase 3

Product

ISL/LEN, B/F/TAF, PTM B/F/TAF, PTM ISL/LEN

Eligibility information

Inclusion criteria

HIV-1 RNA < 50 copies/mL for ≥ 6 months before screening, as documented by:
1. One HIV-1 RNA < 50 copies/mL immediately preceding the 24 week period prior to screening.
2. Within 24 weeks prior to screening, if HIV-1 RNA results are available, all levels must be < 50 copies/mL.
3. During the 6 to 12 months period prior to screening, transient detectable viremia ≥ 50 copies/mL is acceptable ("blip"), as long as it is not confirmed on 2 consecutive visits.
Plasma HIV-1 RNA levels < 50 copies/mL at screening.
Individuals are receiving B/F/TAF for ≥ 6 months prior to screening and willing to continue until Day 1.
Individuals assigned female at birth and of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified methods of contraception.

Exclusion criteria

Prior virologic failure.
Prior use of, or exposure to ISL or LEN.
Active, serious infections requiring parenteral therapy within 30 days before randomization.
Active tuberculosis infection.
Acute hepatitis within 30 days before randomization.
Hepatitis B virus (HBV) infection as determined below at the screening visit:
1. Positive HBV surface antigen OR
2. Positive HBV core antibody and negative HBV surface antibody. Note: individuals found to be susceptible to HBV infection (eg negative hepatitis B surface antibody at the screening visit, regardless of prior HBV vaccination history) should be recommended to receive HBV vaccination.
Active hepatitis C virus (HCV) coinfection, defined as detectable HCV RNA. Note: individuals with prior/inactive HCV infection (defined as undetectable HCV RNA) may be enrolled.
Any of the following laboratory values at screening:
1. Creatinine clearance (CLcr) ≤ 30 mL/min according to the Cockcroft-Gault formula
2. Alanine aminotransferase > 5 x upper limit of normal (ULN)
3. Direct bilirubin > 1.5 x ULN
4. Platelets < 50,000/μL
5. Hemoglobin < 8.0 g/dL
Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations

Locations (106)

Clinical Research Facility (University Hospitals Sussex NHS Foundation Trust)

Brighton, United Kingdom, BN2 3EW

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

For more information, please contact the

For more information, please contact the

OVERVIEW

PROTOCOL SUMMARY

Participation requirements

Study details

Eligibility information

Inclusion criteria

Exclusion criteria

Locations

Locations (106)

Clinical Research Facility (University Hospitals Sussex NHS Foundation Trust)

Grahame Hayton Unit, Ambrose King Centre, Royal London Hospital (Barts Health NHS Trust)

Royal Free Hospital (Royal Free London NHS Foundation Trust)

Clinical Research Facility, 1st Floor, St Stephen's Centre, Chelsea and Westminster Hospital (Chelsea and Westminster Hospital NHS Foundation Trust)

Mortimer Market Centre (Central and North West London NHS Foundation Trust)

Hawthorn House, Birmingham Heartlands Hospital (University Hospitals Birmingham NHS Foundation Trust)

AP-HP-Hopital Bicétre

Universitatsmedizin Essen, Universitatsklinikum Essen, Klinik Dermatologie, Venerologie und Allergologie,, HPSTD-Ambulanz

University Hospital Bonn, Medizinische und Poliklink I, Immunologische Studienambulanz

Centre Hospitalier Universitaire Vaudois

Inselspital

Universitaetsspital Zuerich

ICH Study Center GmbH & Co.KG

CHU Bordeaux - Hopital Saint André

EPIMED GmbHGesellschaft fur klinische und epidemiologische Forschung in Berlin

CHU Nice - Hopital Archet I

Complexo Hospitalario Universitario da Coruna

Hospital Universitario Vall d' Hebron

Hospital Clinic Barcelona

Hospital Universitario Regional de Malaga

Clinique de médecine Urbaine du Quartier Latin

McGill University Health Centr

The Brigham and Women's Hospital, Inc.

Boston Medical Center

Community Research Initiative

Yale University

Jacobi Medical Center

Montefiore Medical Center

New York Presbyterian Hospital

Brooklyn Clinical Research Center

Saint Michael's Medical Center

ID CARE

South Jersey Infectious Disease

Georgetown University

Whitman-Walker Health

Clinical Alliance for Research & Education - Infectious Diseases, LLC (CARE-ID)

MetroHealth Medical Center

Be Well Medical Center

Brody School of Medicine at East Carolina University Adult Specialty Care

Trinity Health

Ohio State University

Duke University

CTRC University of North Carolina at Chapel Hill

Howard Brown Health

University of Cincinnati

University of Wisconsin-Madison

Rosedale Health and Wellness

Atrium Health Infectious Disease Kenilworth

Indiana University School of Medicine

Prisma Health/USC

Chatham CARE Center

Clinical Research Puerto Rico

University of Puerto Rico School of Medicine

Infectious Disease Specialists of Atlanta

Emory University

Mercer University

University of Alabama at Birmingham

Orlando Immunology Center

Midway Immunology and Research Center

KC CARE Health Center

Midland Research Group, Inc.

CAN Community Health

St. Josephs Comprehensive Research Institute

CAN Community Health

CAN Community Health

AHF (AIDS Healthcare Foundation) - Pensacola Research

MultiCare Institute for Research & Innovation

DCOL Center for Clinical Research