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ACTIVE NOT RECRUITING
NCT06333808
PHASE3

Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy

Sponsor: Gilead Sciences

View on ClinicalTrials.gov

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

DRUG

Bictegravir

Tablets administered orally without regard to food

DRUG

Lenacapavir

Tablets administered orally without regard to food

DRUG

B/F/TAF

Tablets administered orally without regard to food

DRUG

Placebo to match B/F/TAF

Tablets administered orally without regard to food

DRUG

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