Study Details

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

Medical Condition

HIV-1-infection

Gender

N/A

Date

October 2024 - June 2026

Study Type

INTERVENTIONAL

Study Phase

PHASE3

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)

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35294

Pueblo Family Physicians

Phoenix, Arizona, United States, 85015

Kaiser Permanente Southern California

Los Angeles, California, United States, 90027

Ruane Clinical Research Group, Inc

Los Angeles, California, United States, 90036

Mills Clinical Research

Los Angeles, California, United States, 90069

BIOS Clinical Research

Palm Springs, California, United States, 92262

Optimus Medical Group

San Francisco, California, United States, 94102

Vivent Health

Denver, Colorado, United States, 80246

University of Colorado- Anschutz Medical Campus - PPDS

Denver, Colorado, United States, 80262

Yale University

New Haven, Connecticut, United States, 06510

Georgetown University

Washington, District of Columbia, United States, 20007

Whitman-Walker Health

Washington, District of Columbia, United States, 20009

CAN Community Health

Fort Lauderdale, Florida, United States, 33316

Midway Immunology and Research Center

Fort Pierce, Florida, United States, 34982

CAN Community Health

Miami Gardens, Florida, United States, 33055

Midland Research Group, Inc.

Oakland Park, Florida, United States, 33334

Orlando Immunology Center

Orlando, Florida, United States, 32803

AHF (AIDS Healthcare Foundation) - Pensacola Research

Pensacola, Florida, United States, 32504

CAN Community Health

Sarasota, Florida, United States, 34237

St. Josephs Comprehensive Research Institute

Tampa, Florida, United States, 33607

Emory University

Atlanta, Georgia, United States, 30308

Infectious Disease Specialists of Atlanta

Decatur, Georgia, United States, 30033

Mercer University

Macon, Georgia, United States, 31201

Chatham CARE Center

Savannah, Georgia, United States, 31401

Howard Brown Health

Chicago, Illinois, United States, 60613

Indiana University School of Medicine

Indianapolis, Indiana, United States, 46202

The Brigham and Women's Hospital, Inc.

Boston, Massachusetts, United States, 02115

Boston Medical Center

Boston, Massachusetts, United States, 02118

Community Research Initiative

Boston, Massachusetts, United States, 02129

Be Well Medical Center

Berkley, Michigan, United States, 48072

Trinity Health

Grand Rapids, Michigan, United States, 49503

KC CARE Health Center

Kansas City, Missouri, United States, 64111

ID CARE

Hillsborough, New Jersey, United States, 08844

Saint Michael's Medical Center

Newark, New Jersey, United States, 07102

South Jersey Infectious Disease

Somers Point, New Jersey, United States, 08244

AXCES Research Group - Albuquerque

Santa Fe, New Mexico, United States, 87505

Jacobi Medical Center

Bronx, New York, United States, 10461

Montefiore Medical Center

Bronx, New York, United States, 10467

Brooklyn Clinical Research Center

Brooklyn, New York, United States, 11226

New York Presbyterian Hospital

Flushing, New York, United States, 11355

CTRC University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States, 27599

Atrium Health Infectious Disease Kenilworth

Charlotte, North Carolina, United States, 28207

Duke University

Durham, North Carolina, United States, 27710

Brody School of Medicine at East Carolina University Adult Specialty Care

Greenville, North Carolina, United States, 27858

Rosedale Health and Wellness

Huntersville, North Carolina, United States, 28078

University of Cincinnati

Cincinnati, Ohio, United States, 45267

MetroHealth Medical Center

Cleveland, Ohio, United States, 44109

Ohio State University

Columbus, Ohio, United States, 43210

Prisma Health/USC

Columbia, South Carolina, United States, 29203

Central Texas Clinical Research

Austin, Texas, United States, 78705

North Texas Infectious Diseases Consultants

Dallas, Texas, United States, 75246

AXCES Research Group, LLC

El Paso, Texas, United States, 79902

Texas Centers for Infectious Disease Associates

Fort Worth, Texas, United States, 76104

The Crofoot Research Center, INC.

Houston, Texas, United States, 77098

DCOL Center for Clinical Research

Longview, Texas, United States, 75605

AXCES Research Group, LLC

Salt Lake City, Utah, United States, 84102

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

Annandale, Virginia, United States, 22003

Peter Shalit MD

Seattle, Washington, United States, 98104

MultiCare Institute for Research & Innovation

Spokane, Washington, United States, 99202

University of Wisconsin-Madison

Madison, Wisconsin, United States, 53705

Fundacion Huesped

Buenos Aires, Argentina, 1202

Helios Salud S.A.

Buenos Aires, Argentina, 1425

East Sydney Doctors

Darlinghurst, New South Wales, Australia, 2010

St Vincent's Hospital

Darlinghurst, New South Wales, Australia, 2010

Taylor Square Private Clinic

Surry Hills, New South Wales, Australia, 2010

Monash Health

Clayton, Victoria, Australia, 3168

Prahran Market Private Clinic

South Yarra, Victoria, Australia, 3141

Clinique de médecine Urbaine du Quartier Latin

Montreal, Canada, H2L 0B1

McGill University Health Centr

Montreal, Canada, H4A 3J1

Spectrum Health

Vancouver, Canada, V6Z 2T1

CHU Bordeaux - Hopital Saint André

Bourdeaux, France, 33075

AP-HP-Hopital Bicétre

Le Kremlin Bicetre, France, 94270

Assistance Publique Hopitaux de Marseille - Hopital Sainte Marguerite

Marseile, France, 13009

CHU Nice - Hopital Archet I

Nice, France, 6203

EPIMED GmbHGesellschaft fur klinische und epidemiologische Forschung in Berlin

Berlin, Germany, 10787

University Hospital Bonn, Medizinische und Poliklink I, Immunologische Studienambulanz

Bonn, Germany, 53127

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

Essen, Germany, 45122

ICH Study Center GmbH & Co.KG

Hamburg, Germany, 20146

Uniklinik Kéin, Innere Medizin |, Klinisches Studienzentrum Infektiologle, Clinical Trials Unit for Infectious Diseases(CTU-ID), ISZ Geb. 80

Köln, Germany, 50924

Chiba University Hospital

Chiba, Japan

National Hospital Organization Nagoya Medical Center

Nagoya, Japan, 460-0001

University of the Ryukyus Hospital

Okinawa, Japan

National Hospital Organization Osaka National Hospital

Osaka Fu, Japan, 540-0006

Osaka City General Hospital

Osaka-City, Japan, 534-0021

Tokyo Medical University Hospital

Tokyo, Japan, 160-0023

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

Tokyo, Japan, 162-8655,

Clinical Research Puerto Rico

San Juan, Puerto Rico, 00909

University of Puerto Rico School of Medicine

San Juan, Puerto Rico, 00935

Hospital Universitario Vall d' Hebron

Barcelona, Spain, 08035

Hospital Clinic Barcelona

Barcelona, Spain, 08036

Complexo Hospitalario Universitario da Coruna

La Coruña, Spain, 15006

Hospital Universitario Regional de Malaga

Málaga, Spain, 29010

Inselspital

Bern, Switzerland, 3010

Centre Hospitalier Universitaire Vaudois

Lausanne, Switzerland, 1011

Universitaetsspital Zuerich

Zurich, Switzerland, 8091

Kaohsuing Medical University Hospital

Kaohsiung, Taiwan, 80756

Kaohsuing Veterans General Hospital

Kaohsiung, Taiwan, 81362

Far Eastern Memorial Hospital

New Taipei City, Taiwan, 22060

National Taiwan University Hospital

Taipei City, Taiwan, 10002

Taoyuan General Hospital

Taoyuan City, Taiwan, 33004

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

Birmingham, United Kingdom, B9 5SS

Clinical Research Facility (University Hospitals Sussex NHS Foundation Trust)

Brighton, United Kingdom, BN2 3EW

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

London, United Kingdom, E1 1BB.

Royal Free Hospital (Royal Free London NHS Foundation Trust)

London, United Kingdom, NW3 2QG

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

London, United Kingdom, SW10 9TH

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

London, United Kingdom, WC1E 6JB

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

OVERVIEW

PROTOCOL SUMMARY

Participation Requirements

Eligibility Information

Inclusion Criteria

Exclusion Criteria

Locations

Locations (106)

University of Alabama at Birmingham

Pueblo Family Physicians

Kaiser Permanente Southern California

Ruane Clinical Research Group, Inc

Mills Clinical Research

BIOS Clinical Research

Optimus Medical Group

Vivent Health

University of Colorado- Anschutz Medical Campus - PPDS

Yale University

Georgetown University

Whitman-Walker Health

CAN Community Health

Midway Immunology and Research Center

CAN Community Health

Midland Research Group, Inc.

Orlando Immunology Center

AHF (AIDS Healthcare Foundation) - Pensacola Research

CAN Community Health

St. Josephs Comprehensive Research Institute

Emory University

Infectious Disease Specialists of Atlanta

Mercer University

Chatham CARE Center

Howard Brown Health

Indiana University School of Medicine

The Brigham and Women's Hospital, Inc.

Boston Medical Center

Community Research Initiative

Be Well Medical Center

Trinity Health

KC CARE Health Center

ID CARE

Saint Michael's Medical Center

South Jersey Infectious Disease

AXCES Research Group - Albuquerque

Jacobi Medical Center

Montefiore Medical Center

Brooklyn Clinical Research Center

New York Presbyterian Hospital

CTRC University of North Carolina at Chapel Hill

Atrium Health Infectious Disease Kenilworth

Duke University

Brody School of Medicine at East Carolina University Adult Specialty Care

Rosedale Health and Wellness

University of Cincinnati

MetroHealth Medical Center

Ohio State University

Prisma Health/USC

Central Texas Clinical Research

North Texas Infectious Diseases Consultants

AXCES Research Group, LLC

Texas Centers for Infectious Disease Associates

The Crofoot Research Center, INC.

DCOL Center for Clinical Research

AXCES Research Group, LLC

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

Peter Shalit MD

MultiCare Institute for Research & Innovation

University of Wisconsin-Madison

Fundacion Huesped

Helios Salud S.A.

East Sydney Doctors

St Vincent's Hospital

Taylor Square Private Clinic

Monash Health

Prahran Market Private Clinic

Clinique de médecine Urbaine du Quartier Latin

McGill University Health Centr

Spectrum Health