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Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed People With HIV-1
Sponsor: Gilead Sciences
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
ISL/LEN
Tablet administered orally
B/F/TAF
Tablet administered orally
PTM B/F/TAF
Tablet administered orally
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