STATUS Recruitment Complete

Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Standard of Care in Virologically Suppressed People With HIV-1 (ISLEND-2)

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

STATUS

Recruitment Complete

GILEAD STUDY ID

GS-US-563-5926

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

LAST UPDATED

May 29, 2026

Clinicaltrials.gov ID

NCT06630299

CTSID

2024-514047-28

OVERVIEW

A Phase 3, Randomized, Open-Label, Active-Controlled Study to Evaluate a Switch to an Oral Weekly Islatravir/Lenacapavir Regimen in People With HIV-1 Who Are Virologically Suppressed on Standard of Care (ISLEND-2)

PROTOCOL SUMMARY

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.

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, Antiretroviral Combinations

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 weeks 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.
Are receiving guideline-recommended standard of care treatment such as International Antiviral Society (IAS), Department of Health and Human Services (DHHS), European AIDS Clinical Society (EACS) consisting of 2 or 3 ARVs for ≥ 6 months prior to screening and willing to continue until Day 1. Individuals in Treatment Group 2 must also be willing to continue their standard of care through at least Week 96.
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 (ALT) > 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 (100)

University of Alabama at Birmingham(UAB) 1917 Research Clinic

Birmingham, Alabama, United States, 35294

Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Standard of Care in Virologically Suppressed People With HIV-1 (ISLEND-2)

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 (100)

University of Alabama at Birmingham(UAB) 1917 Research Clinic

Pueblo Family Physicians

Vv-Tmf-5366229

Ruane Clinical Research Group

BIOS Clinical Research

Vivent Health

University of Colorado Clinical and Translational Research Center

Yale University; School of Medicine; AIDS Program

Georgetown University Medical Center

Aids Healthcare Foundation - Northpoint

Midway Immunology and Research Center

CAN Community Health

Orlando Immunology Center

AHF Pensacola

CAN Community Health

BayCare Health System, Inc./St. Joseph's Hospital

Triple O Research Institute, P.A.

Metro Infectious Disease Consultants, P.L.L.C.

Mercer University, Department of Internal Medicine

Chatham County Health Department

Howard Brown Health Center

Indiana CTSI Clinical Research Center

Brigham and Womens's Hospital

Boston Medical Center

Community Research Initiative of New England d/b/a Community Resource Initiative (CRI)

Be Well Medical Center

Henry Ford Health

Trinity Health Michigan d/b/a Trinity Health Grand Rapids Hospital

ID Care

Saint Michael's Medical Center

AXCES Research Group, LLC

NewYork-Presbyterian Queens

Northwell Health/Division of Infectious Diseases

Jacobi Medical Center

Montefiore Medical Center

Duke University Health System(DUHS)

ECU Health Leo Jenkins Cancer Building

Rosedale Health and Wellness

University of Cincinnati College of Medicine

Prisma Health Midlands - Clinical Research Unit

Central Texas Clinical Research

North Texas Infectious Diseases Consultants, PA

AXCES Research Group, LLC

Texas Centers for Infectious Disease Associates

The Crofoot Research Center, INC.

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

AXCES Research Group, LLC

Clinical Alliance for Research& Education - Infectious Diseases, LLC

MultiCare Rockwood Main Clinic

Hospital General de Agudos Dr. J.M. Ramos Mejia

Fundacion Huesped

Helios Salud S.A.

East Sydney Doctors

St Vincent's Hospital

Taylor Square Private Clinic

Monash Health

Prahran Market Clinic

Dr. Scholten & Schneeweiß GbR

University Hospital Hannover, Department for Rheumatology and Immunology

Mannheimer Onkologie Praxis

MVZ München am Goetheplatz, MUC Research GmbH

Chiba University Hospital

National Hospital Organization Nagoya Medical Center

University of the Ryukyus Hospital

Osaka City General Hospital

National Hospital Organization Osaka National Hospital

Tokyo Medical University Hospital

Japan Institute for Health Security National Center for Global Health and Medicine