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ACTIVE NOT RECRUITING
NCT06630286
PHASE3

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

Sponsor: Gilead Sciences

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

609

Start Date

2024-10-09

Completion Date

2030-08

Last Updated

2025-11-13

Healthy Volunteers

No

Conditions

Interventions

DRUG

ISL/LEN

Tablet administered orally

DRUG

B/F/TAF

Tablet administered orally

DRUG

PTM B/F/TAF

Tablet administered orally

DRUG

PTM ISL/LEN

Tablet administered orally

Locations (106)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Pueblo Family Physicians

Phoenix, Arizona, United States

Kaiser Permanente Southern California

Los Angeles, California, United States

Ruane Clinical Research Group, Inc

Los Angeles, California, United States

Mills Clinical Research

Los Angeles, California, United States

BIOS Clinical Research

Palm Springs, California, United States

Optimus Medical Group

San Francisco, California, United States

Vivent Health

Denver, Colorado, United States

University of Colorado- Anschutz Medical Campus - PPDS

Denver, Colorado, United States

Yale University

New Haven, Connecticut, United States

Georgetown University

Washington D.C., District of Columbia, United States

Whitman-Walker Health

Washington D.C., District of Columbia, United States

CAN Community Health

Fort Lauderdale, Florida, United States

Midway Immunology and Research Center

Ft. Pierce, Florida, United States

CAN Community Health

Miami Gardens, Florida, United States

Midland Research Group, Inc.

Oakland Park, Florida, United States

Orlando Immunology Center

Orlando, Florida, United States

AHF (AIDS Healthcare Foundation) - Pensacola Research

Pensacola, Florida, United States

CAN Community Health

Sarasota, Florida, United States

St. Josephs Comprehensive Research Institute

Tampa, Florida, United States

Emory University

Atlanta, Georgia, United States

Infectious Disease Specialists of Atlanta

Decatur, Georgia, United States

Mercer University

Macon, Georgia, United States

Chatham CARE Center

Savannah, Georgia, United States

Howard Brown Health

Chicago, Illinois, United States

Indiana University School of Medicine

Indianapolis, Indiana, United States

The Brigham and Women's Hospital, Inc.

Boston, Massachusetts, United States

Boston Medical Center

Boston, Massachusetts, United States

Community Research Initiative

Boston, Massachusetts, United States

Be Well Medical Center

Berkley, Michigan, United States

Trinity Health

Grand Rapids, Michigan, United States

KC CARE Health Center

Kansas City, Missouri, United States

ID CARE

Hillsborough, New Jersey, United States

Saint Michael's Medical Center

Newark, New Jersey, United States

South Jersey Infectious Disease

Somers Point, New Jersey, United States

AXCES Research Group - Albuquerque

Santa Fe, New Mexico, United States

Brooklyn Clinical Research Center

Brooklyn, New York, United States

New York Presbyterian Hospital

Flushing, New York, United States

Jacobi Medical Center

The Bronx, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

CTRC University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Atrium Health Infectious Disease Kenilworth

Charlotte, North Carolina, United States

Duke University

Durham, North Carolina, United States

Brody School of Medicine at East Carolina University Adult Specialty Care

Greenville, North Carolina, United States

Rosedale Health and Wellness

Huntersville, North Carolina, United States

University of Cincinnati

Cincinnati, Ohio, United States

MetroHealth Medical Center

Cleveland, Ohio, United States

Ohio State University

Columbus, Ohio, United States

Prisma Health/USC

Columbia, South Carolina, United States

Central Texas Clinical Research

Austin, Texas, United States

North Texas Infectious Diseases Consultants

Dallas, Texas, United States

AXCES Research Group, LLC

El Paso, Texas, United States

Texas Centers for Infectious Disease Associates

Fort Worth, Texas, United States

The Crofoot Research Center, INC.

Houston, Texas, United States

DCOL Center for Clinical Research

Longview, Texas, United States

AXCES Research Group, LLC

Salt Lake City, Utah, United States

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

Annandale, Virginia, United States

Peter Shalit MD

Seattle, Washington, United States

MultiCare Institute for Research & Innovation

Spokane, Washington, United States

University of Wisconsin-Madison

Madison, Wisconsin, United States

Fundacion Huesped

Buenos Aires, Argentina

Helios Salud S.A.

Buenos Aires, Argentina

East Sydney Doctors

Darlinghurst, New South Wales, Australia

St Vincent's Hospital

Darlinghurst, New South Wales, Australia

Taylor Square Private Clinic

Surry Hills, New South Wales, Australia

Monash Health

Clayton, Victoria, Australia

Prahran Market Private Clinic

South Yarra, Victoria, Australia

Clinique de médecine Urbaine du Quartier Latin

Montreal, Canada

McGill University Health Centr

Montreal, Canada

Spectrum Health

Vancouver, Canada

CHU Bordeaux - Hopital Saint André

Bourdeaux, France

AP-HP-Hopital Bicétre

Le Kremlin-Bicêtre, France

Assistance Publique Hopitaux de Marseille - Hopital Sainte Marguerite

Marseile, France

CHU Nice - Hopital Archet I

Nice, France

EPIMED GmbHGesellschaft fur klinische und epidemiologische Forschung in Berlin

Berlin, Germany

University Hospital Bonn, Medizinische und Poliklink I, Immunologische Studienambulanz

Bonn, Germany

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

Cologne, Germany

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

Essen, Germany

ICH Study Center GmbH & Co.KG

Hamburg, Germany

Chiba University Hospital

Chiba, Japan

National Hospital Organization Nagoya Medical Center

Nagoya, Japan

University of the Ryukyus Hospital

Okinawa, Japan

Osaka City General Hospital

Osaka, Japan

National Hospital Organization Osaka National Hospital

Osaka Fu, Japan

Tokyo Medical University Hospital

Tokyo, Japan

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

Tokyo, Japan

Clinical Research Puerto Rico

San Juan, PR, Puerto Rico

University of Puerto Rico School of Medicine

San Juan, PR, Puerto Rico

Complexo Hospitalario Universitario da Coruna

A Coruña, Spain

Hospital Universitario Vall d' Hebron

Barcelona, Spain

Hospital Clinic Barcelona

Barcelona, Spain

Hospital Universitario Regional de Malaga

Málaga, Spain

Inselspital

Bern, Switzerland

Centre Hospitalier Universitaire Vaudois

Lausanne, Switzerland

Universitaetsspital Zuerich

Zurich, Switzerland

Kaohsuing Medical University Hospital

Kaohsiung City, Taiwan

Kaohsuing Veterans General Hospital

Kaohsiung City, Taiwan

Far Eastern Memorial Hospital

New Taipei City, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Taoyuan General Hospital

Taoyuan, Taiwan

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

Birmingham, United Kingdom

Clinical Research Facility (University Hospitals Sussex NHS Foundation Trust)

Brighton, United Kingdom

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

London, United Kingdom

Royal Free Hospital (Royal Free London NHS Foundation Trust)

London, United Kingdom

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

London, United Kingdom

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

London, United Kingdom