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Study to Evaluate the Safety and Efficacy of Lenacapavir (GS-6207) in Combination With an Optimized Background Regimen (OBR) in Heavily Treatment Experienced Participants Living With HIV-1 Infection With Multidrug Resistance
Sponsor: Gilead Sciences
Summary
The primary objective of this study is to evaluate the antiviral activity of lenacapavir (formerly GS-6207) administered as an add-on to a failing regimen for 14 days (functional monotherapy) in people with human immunodeficiency virus type 1 (HIV-1) (PWH) with multi-drug resistance (MDR).
Official title: A Phase 2/3 Study to Evaluate the Safety and Efficacy of Long-Acting Capsid Inhibitor GS-6207 in Combination With an Optimized Background Regimen in Heavily Treatment Experienced People Living With HIV-1 Infection With Multidrug Resistance
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
INTERVENTIONAL
Enrollment
72
Start Date
2019-11-21
Completion Date
2027-01
Last Updated
2026-03-13
Healthy Volunteers
No
Conditions
Interventions
Oral Lenacapavir
Tablets administered without regard to food
Oral Lenacapavir Placebo
Tablets administered without regard to food
Subcutaneous Lenacapavir
Administered in the abdomen via subcutaneous injections
Failing ARV Regimen
Failing antiretroviral (ARV) regimen defined by the lack of efficacy. Any combination of approved and unapproved agents that could potentially be part of the failing regimen.
Optimized Background Regimen (OBR)
Optimized background regimen as prescribed by the Investigator
Locations (75)
Ruane Clinical Research Group Inc
Los Angeles, California, United States
Mills Clinical Research
Los Angeles, California, United States
Eisenhower Health Center at Rimrock
Palm Springs, California, United States
One Community Health
Sacramento, California, United States
Yale University; School of Medicine
New Haven, Connecticut, United States
Washington Health Institute
Washington D.C., District of Columbia, United States
Midland Florida Clinical Research Center, LLC
DeLand, Florida, United States
Gary J. Richmond, M.D., P.A.
Fort Lauderdale, Florida, United States
Midway Immunology and Research Center
Ft. Pierce, Florida, United States
Floridian Clinical Research
Hialeah, Florida, United States
AIDS Healthcare Foundation - South Beach
Miami Beach, Florida, United States
Orlando Immunology Center
Orlando, Florida, United States
St. Joseph's Hospital Comprehensive Research Institute
Tampa, Florida, United States
Triple O Research Institute, P.A.
West Palm Beach, Florida, United States
Emory Hospital Midtown Infectious Disease Clinic
Atlanta, Georgia, United States
Atlanta ID Group, PC
Atlanta, Georgia, United States
Chatham County Health Department
Savannah, Georgia, United States
Howard Brown Health Center
Chicago, Illinois, United States
Northstar Healthcare
Chicago, Illinois, United States
Be Well Medical Center
Berkley, Michigan, United States
Southampton Healthcare, Inc.
St Louis, Missouri, United States
New York-Presbyterian/Queens
Flushing, New York, United States
North Shore University Hospital/Division of Infectious Diseases
Manhasset, New York, United States
Jacobi Medical Center
The Bronx, New York, United States
Atrium Health- Infectious Disease Consultants
Charlotte, North Carolina, United States
Perelman Center for Advanced Medicine at the Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
The Miriam Hospital
Providence, Rhode Island, United States
1265 Union Avenue, 8 East
Memphis, Tennessee, 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, P.A.
Dallas, Texas, United States
The Crofoot Research Center, INC.
Houston, Texas, United States
DCOL Center for Clinical Research
Longview, Texas, United States
Clinical Alliance for Research and Education - Infectious Diseases, LLC (CARE-ID)
Annandale, Virginia, United States
Vancouver ID Research and Care Centre Society
Vancouver, British Columbia, Canada
Maple Leaf Research/Maple Leaf Medical Clinic
Toronto, Ontario, Canada
Clinique de médecine urbaine du Quartier Latin
Montreal, Quebec, Canada
The Ottawa Hospital
Ottawa, Canada
Instituto Dominicano de Estudios Virologicos (IDEV)
Santo Domingo, Dominican Republic
Hospital Dr. Salvador Bienvenido Gautier
Santo Domingo, Dominican Republic
Hôpital Sainte-Marguerite
Marseille, France
Hôpital Saint-Louis
Paris, France
Hôpital Saint-Antoine
Paris, France
Hôpital Bichat-Claude Bernard
Paris, France
Universitätsklinikum Frankfurt, Medizinische Klinik II
Frankfurt am Main, Hesse, Germany
Universitätsklinikum Essen, Klinik für Dermatologie und Venerologie
Essen, Germany
ICH Study Center GmbH & Co. KG
Hamburg, Germany
University of Naples Federico II
Bergamo, Italy
UOC Malattie Infettive - ASST Spedali Civili Di Brescia - Piazzale Spedali Civili 1
Brescia, Italy
Divisione di Malattie Infettive, IRCCS Ospedale San Raffaele
Milan, Italy
U.O.C. IMMUNODEFICIENZE VIRALI - Istituto Nazionale Malattie Infettive Lazzaro Spallanzani IRCCS
Roma, Italy
U.O.C. Malattie Infettive - Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, Italy
National Hospital Organization Nagoya Medical Center
Nagoya, Japan
National Hospital Organization Osaka National Hospital
Osaka, Japan
Tokyo Medical University Hospital
Tokyo, Japan
Center Hospital of the National Center for Global Health and Medicine
Tokyo, Japan
Durban International Clinical Research Site, Enhancing Care Foundation
Durban, South Africa
Helen Joseph Hospital
Johannesburg, South Africa
Vx Pharma
Pretoria, South Africa
Perinatal HIV Research Unit (PHRU)
Soweto, South Africa
Hospital Universitari Germans Trías i Pujol
Badalona, Spain
Hospital Clinic de Barcelona
Barcelona, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Universitario Virgen del Rocío
Seville, Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung City, Taiwan
Far Eastern Memorial Hospital
New Taipei City, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taoyuan General Hospital, Ministry of Health and Welfare
Taoyuan, Taiwan
Thai Red Cross AIDS Research Center
Bangkok, Thailand
Faculty of Medicine Ramathibodi Hospital, Mahidol University
Bangkok, Thailand
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, Thailand
Faculty of Medicine, Khon Kaen University
Khon Kaen, Thailand
Bamrasnaradura Infectious Diseases Institute
Nonthaburi, Thailand