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Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen
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) plus lenacapavir (LEN), versus current therapy (Phase 2) and BIC/LEN fixed-dose combination (FDC) versus current therapy (Phase 3) in people living with HIV (PWH).
Official title: An Operationally Seamless Phase 2/3 Randomized, Open-label, Multicenter, Active-Controlled Study to Evaluate the Safety and Efficacy of Bictegravir/Lenacapavir Versus Stable Baseline Regimen in Virologically Suppressed People With HIV-1 on Stable Complex Treatment Regimens
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
689
Start Date
2022-08-16
Completion Date
2028-07
Last Updated
2025-10-14
Healthy Volunteers
No
Conditions
Interventions
Bictegravir
Tablets administered orally without regard to food
Lenacapavir
Tablets administered orally without regard to food
BIC/LEN FDC
Tablets administered orally without regard to food
Stable Baseline Regimen
SBR will include a combination of antiretroviral (ARV) regimen. ARV regimen may include the following, except for participants taking a single tablet regimen or taking a complete parenteral regimen (Cabenuva). * Nucleos(t)ide Reverse Transcriptase Inhibitors: * Abacavir * Emtricitabine * Lamivudine * Tenofovir alafenamide * Tenofovir disoproxil fumarate * Zidovudine * Non-Nucleosite Reverse Transcriptase Inhibitors: * Delavirdine * Efavirenz * Nevirapine * Rilpivirine * Doravirine * Integrase Inhibitors: * Bictegravir * Cabotegravir * Dolutegravir * Elvitegravir * Raltegravir * Protease Inhibitors: * Atazanavir * Darunavir * Fosamprenavir * Indinavir * Lopinavir * Nelfinavir * Saquinavir * Tipranavir * Chemokine Co-receptor 5 (CCR5) Antagonist: * Maraviroc * Fusion Inhibitors: * Enfuvirtide * gp120 Attachment Inhibitor: * Fostemsavir * Anti-CD4 Monoclonal Antibodies: * Ibalizumab-uiyk
Locations (94)
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
University of California San Diego (UCSD)
San Diego, California, United States
Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical Center
Torrance, California, United States
The Men's Health Foundation
West Hollywood, California, United States
Denver Health Medical Center
Denver, Colorado, United States
Yale University; School of Medicine; AIDS Program
New Haven, Connecticut, United States
Midland Florida Clinical Research Center, LLC
DeLand, Florida, United States
Therafirst Medical Centers
Fort Lauderdale, Florida, United States
Gary Richmond, MD, PA, Inc.
Fort Lauderdale, Florida, United States
Midway Immunology & Research Center, LLC
Ft. Pierce, 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
Therapeutic Concepts, PA
Orlando, Florida, United States
Triple O Research Institute PA
West Palm Beach, Florida, United States
Atlanta ID Group
Atlanta, Georgia, United States
Mercer University School of Medicine
Macon, Georgia, United States
Howard Brown Health Center
Chicago, Illinois, United States
Kansas City Care Clinic
Kansas City, Missouri, United States
Southampton Healthcare, Inc.
St Louis, Missouri, United States
Saint Michael's Medical Center
Newark, New Jersey, United States
AXCES Research Group
Santa Fe, New Mexico, United States
New York Presbyterian Hospital
Flushing, New York, United States
Ricky K. Hsu, MD, PC
New York, New York, United States
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
East Carolina University
Greenville, North Carolina, United States
Philadelphia FIGHT
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
Bellaire, Texas, United States
AIDS Arms, Inc., DBA Prism Health North Texas
Dallas, Texas, United States
North Texas Infectious Diseases Consultants
Dallas, Texas, United States
Texas Centers for Infectious Disease Associates
Fort Worth, Texas, United States
Gordon E. Crofoot MD PA
Houston, Texas, United States
Diagnostic Clinic of Longview - Center for Clinical Research
Longview, Texas, United States
Peter Shalit, MD
Seattle, Washington, United States
Hospital General de Agudos J.M Ramon Mejia
Buenos Aires, Argentina
Fundación Huésped
Buenos Aires, Argentina
Helios Salud
Buenos Aires, Argentina
St.Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia
Taylor Square Private Clinic
Darlinghurst, New South Wales, Australia
Holdsworth House Medical Practice
Sydney, New South Wales, Australia
Alfred Health
Melbourne, Victoria, Australia
Chronic Viral Illness Service / McGill University Health Centre (MUHC)
Decarie Montreal, Canada
Clinique Medicale du Quartier Latin
Montreal, Canada
The Ottawa Hospital - General Campus
Ottawa, Canada
ID Clinic
Regina, Canada
Maple Leaf Research
Toronto, Canada
Spectrum Health
Vancouver, Canada
Instituto Dominicano de Estudio Virologicos - IDEV
Santo Domingo, Dominican Republic
CHU Nice-Hôpital l'Archet
Nice, France
Hospital Saint Louis
Paris, France
Groupe Hospitalier Bichat Claude Bernard
Paris, France
Höpital de la Pitié Salpêtrière
Paris, France
zibp Zentrum für Infektiologie Berlin Prenzlauer Berg GmbH
Berlin, Germany
Universitatsklinikum Bonn
Bonn, Germany
Infektio Research GmbH & Co.KG
Frankfurt, Germany
ICH Study Center GmbH & Co. KG
Hamburg, Germany
MVZ München am Goetheplatz
München, Germany
IRCCS Ospedale San Raffaele
Milan, Italy
ASST Fatebenefratelli Sacco
Milan, Italy
Azienda Ospedaliero-Universitaria di Modena
Modena, Italy
Istituto Nazionale Malattie Infettive "Lazzaro Spallanzani" IRCCS
Roma, Italy
ASL Città di Torino
Torino, Italy
National Hospital Organization Nagoya Medical Center
Nagoya, Japan
National Hospital Organization Osaka National Hospital
Osaka, Japan
Center Hospital of the National Center for Global Health and Medicine
Tokyo, Japan
Hope Clinical Research
San Juan, PR, Puerto Rico
Proyecto ACTU
San Juan, PR, Puerto Rico
Desmond Tutu Health Foundation Clinical Trials Unit
Cape Town, South Africa
Sefako Makgatho Health Sciences University
Ga-Rankuwa, South Africa
Ezintsha
Johannesburg, South Africa
Kyungpook National University Hospital
Daegu, South Korea
Chungnam National University Hospital
Daejeon, South Korea
Yonsei University Severance Hospital
Seoul, South Korea
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, South Korea
Hospital Clinic Provincial de Barcelona
Barcelona, Spain
Hospital Ramon y Cajal, Madrid
Madrid, Spain
Hospital Clinico San Carlos
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Universitario Virgen del Rocio
Seville, Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
Far Eastern Memorial Hospital
New Taipei City, Taiwan
Taoyuan General Hospital
Taoyuan, Taiwan
Department of HIV & Sexual Medicine
Birmingham, United Kingdom
Brighton and Sussex University Hospitals NHS Trust
Brighton, United Kingdom
Barts Health NHS Trust
London, United Kingdom
HIV medicine and infectious diseases
London, United Kingdom
St.Stephen's AIDS Trust, Clinical Trials Unit, 1st Floor, St.Stephen's Centre
London, United Kingdom