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Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy
Sponsor: Gilead Sciences
Summary
The goal of this clinical study is to learn more about the effects of switching to the study drugs, bictegravir (BIC)/lenacapavir (LEN), fixed-dose combination (FDC) versus current therapy bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) FDC in people living with HIV-1 (PWH). The primary objective of this study is to learn how effective it is to switch to BIC/LEN FDC tablets versus continuing on B/F/TAF FDC tablets in virologically suppressed PWH.
Official title: Phase 3 Double-blind Multicenter Randomized Active-Controlled Study to Evaluate the Safety and Efficacy of Bictegravir/Lenacapavir Versus Biktarvy® (Bictegravir/Emtricitabine/Tenofovir Alafenamide) in Virologically Suppressed People With HIV-1
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
577
Start Date
2024-03-25
Completion Date
2029-12
Last Updated
2025-11-05
Healthy Volunteers
No
Conditions
Interventions
Bictegravir
Tablets administered orally without regard to food
Lenacapavir
Tablets administered orally without regard to food
B/F/TAF
Tablets administered orally without regard to food
Placebo to match B/F/TAF
Tablets administered orally without regard to food
Placebo to match BIC/LEN
Tablets administered orally without regard to food
Locations (104)
Pueblo Family Physicians
Phoenix, Arizona, United States
Be Well Medical Center
Berkeley, California, United States
Pacific Oaks Medical Group
Beverly Hills, California, United States
Ruane Clinical Research Group Inc.
Los Angeles, California, United States
Alta Bates Summit Medical Center, Summit Campus, East Bay Advanced Care
Oakland, California, United States
BIOS Clinical Research
Palm Springs, California, United States
UCSD Anti Viral Research Centre (AVRC)
San Diego, California, United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, United States
Mills Clinical Research
West Hollywood, California, United States
Public Health Institute at Denver Health
Denver, Colorado, United States
Yale University School of Medicine (study visits)
New Haven, Connecticut, United States
Midland Florida Infectious Diseases Specialists, PL - Orange City
DeLand, Florida, United States
Therafirst Medical Center
Fort Lauderdale, Florida, United States
CAN Community Health
Fort Lauderdale, Florida, United States
Midway Immunology and Research Center
Ft. Pierce, Florida, United States
AIDS Healthcare Foundation - The Kinder Medical Group
Miami, Florida, United States
Schiff Center for liver Diseases/University of Miami
Miami, Florida, United States
Floridian Clinical Research
Miami Lakes, Florida, United States
Orlando Immunology Center
Orlando, Florida, United States
Bliss Healthcare
Orlando, Florida, United States
AHF Pensacola
Pensacola, Florida, United States
CAN community Health
Sarasota, Florida, United States
Triple O Research Institute, P.A.
West Palm Beach, Florida, United States
Infectious Disease Specialists of Atlanta
Decatur, Georgia, United States
Mercer University, Department of Internal Medicine
Macon, Georgia, United States
Claudia T Martorell MD LLC dba The Research Institute
Springfield, Massachusetts, United States
Henry Ford Health
Detroit, Michigan, United States
KC Care health Center
Kansas City, Missouri, United States
Southampton Community Healthcare, Inc.
St Louis, Missouri, United States
ID Care, LLC
Hillsborough, New Jersey, United States
Saint Michael's Medical Center
Newark, New Jersey, United States
New Jersey Medical School - Clinical Research Center
Newark, New Jersey, United States
South Jersey Infectious Disease
Somers Point, New Jersey, United States
AXCES Research Group, LLC
Santa Fe, New Mexico, United States
New York-Presbyterian Queens
Flushing, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
The Brody School of Medicine at East Carolina University , ECU Adult Specialty Care
Greenville, North Carolina, United States
Rosedale Health and Wellness
Huntersville, North Carolina, United States
Philadelphia FIGHT Community Health Centers
Philadelphia, Pennsylvania, United States
Medical University of South Carolina (MUSC) Research Nexus
Charleston, South Carolina, United States
Central Texas Clinical Research
Austin, Texas, United States
St Hope Foundation, Inc.
Bellaire, Texas, United States
AIDS Arms, Inc. DBA Prism Health North Texas
Dallas, Texas, United States
North Texas Infectious Diseases Consultants, PA
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
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
Community Health care
Tacoma, Washington, United States
Helios Salud S.A.
Buenos Aires, Argentina
Fundacion Huesped
Buenos Aires, Argentina
Instituto CAICI SRL
Santa Fe, Argentina
Taylor Square Private Clinic
Darlinghurst, New South Wales, Australia
Alfred Hospital(Alfred Health)
Melbourne, Victoria, Australia
Prahran Market Clinic
South Yarra, Victoria, Australia
Chronic Viral Illness Service/McGill University Health Centre (MUHC)
Decarie Montreal, Canada
Clinique Médicale l'Actuel
Montreal, Canada
The Ottawa Hospital - General Campus
Ottawa, Canada
Regina General Hospital
Regina, Canada
St. Paul's Hospital, John Ruedy Clinic-Immunodeficiency Clinic (JRC-IDC)
Vancouver, Canada
Cool Aid Community Health Centre
Victoria, Canada
Instituto Dominicano de Estudios Virologicos - IDEV
Santo Domingo, Dominican Republic
Praxis Dr. Knechten
Aachen, Germany
Novopraxis Berlin
Berlin, Germany
Praxis am Ebertplatz
Cologne, Germany
Universitätsklinikum Frankfurt
Frankfurt, Germany
Universitätsklinikum Hamburg Eppendorf
Hamburg, Germany
LMU Klinikum der Universität
Munich, Germany
Klinikum rechts der Isar der Technischen Universitaet Muenchen
München, Germany
ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia - INCIPIT - PIN
Brescia, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti (Policlinico di Foggia)
Foggia, Italy
IRCCS Ospedale San Raffaele
Milan, Italy
Fondazione IRCCS San Gerardo dei Tintori - ASST di Monza - A. O. San Gerardo
Monza, Italy
Fondazione IRCCS Policlinico San Matteo di Pavia
Pavia, Italy
Istituto Nazionale Malattie Infettive Lazzaro Spallanzani IRCCS
Roma, Italy
Fondazione Policlinico Universitario A Gemelli-Rome
Roma, Italy
National Hospital Organization Nagoya Medical Center
Aichi, Japan
National Hospital Organization Osaka National Hospital
Osaka, Japan
Center Hospital of the National Center for Global Health and Medicine
Tokyo, Japan
ProcliniQ Investigacion Clinica Toriello Guerra, Tlalpan
Mexico City, Mexico
Unidad de Atencion Medica e Investigacion en Salud
Mérida, Mexico
HOPE Clinical Research
San Juan, PR, Puerto Rico
Proyecto ACTU
San Juan, PR, Puerto Rico
Kyungpook National University Hospital
Daegu, South Korea
National Medical Center
Seoul, South Korea
Severance Hospital, Yonsei University Health System
Seoul, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, South Korea
Hospital Universitario Germans Trias i Pujol
Badalona Barcelona, Spain
Hospital Clinic de Barcelona
Barcelona, Spain
Hospital Universitario Ramon y Cajal
Madrid, Spain
Hospital Universitario La Paz - PPDS
Madrid, Spain
Hospital Universitario Virgen del Rocio - PPDS
Seville, Spain
Consorcio Hospital General Universitario de Valencia
Valencia, Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung City, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taoyuan General Hospital, Ministry of Health and Welfare
Taoyuan, Taiwan
Liverpool University Hospitals NHS Foundation Trust, Royal Liverpool Hospital
Liverpool, United Kingdom
King's College Hospital, Weston Education Centre
London, United Kingdom
Chelsea and Westminster Hospital NHS Foundation Trust, St Stephen's Centre, Chelsea and Westminster Hospital
London, United Kingdom
St Mary's Hospital - PPDS
London, United Kingdom
Mortimer Market Centre
London, United Kingdom