72
Participants
Start Date
November 21, 2019
Primary Completion Date
October 5, 2020
Study Completion Date
January 31, 2027
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
Vx Pharma, Pretoria
Perinatal HIV Research Unit (PHRU), Soweto
Helen Joseph Hospital, Johannesburg
Durban International Clinical Research Site, Enhancing Care Foundation, Durban
National Taiwan University Hospital, Taipei
Instituto Dominicano de Estudios Virologicos (IDEV), Santo Domingo
Thai Red Cross AIDS Research Center, Bangkok
Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok
Jacobi Medical Center, The Bronx
Hospital Dr. Salvador Bienvenido Gautier, Santo Domingo
Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok
Bamrasnaradura Infectious Diseases Institute, Nonthaburi
North Shore University Hospital/Division of Infectious Diseases, Manhasset
New York-Presbyterian/Queens, Flushing
Hôpital Sainte-Marguerite, Marseille
Perelman Center for Advanced Medicine at the Hospital of the University of Pennsylvania, Philadelphia
Washington Health Institute, Washington D.C.
Divisione di Malattie Infettive, IRCCS Ospedale San Raffaele, Milan
ICH Study Center GmbH & Co. KG, Hamburg
Clinical Alliance for Research and Education - Infectious Diseases, LLC (CARE-ID), Annandale
Far Eastern Memorial Hospital, New Taipei City
University of Naples Federico II, Bergamo
UOC Malattie Infettive - ASST Spedali Civili Di Brescia - Piazzale Spedali Civili 1, Brescia
Hospital Universitario La Paz, Madrid
Atrium Health- Infectious Disease Consultants, Charlotte
Emory Hospital Midtown Infectious Disease Clinic, Atlanta
Atlanta ID Group, PC, Atlanta
Chatham County Health Department, Savannah
Midland Florida Clinical Research Center, LLC, DeLand
Orlando Immunology Center, Orlando
Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan
Floridian Clinical Research, Hialeah
AIDS Healthcare Foundation - South Beach, Miami Beach
Gary J. Richmond, M.D., P.A., Fort Lauderdale
Triple O Research Institute, P.A., West Palm Beach
St. Joseph's Hospital Comprehensive Research Institute, Tampa
Midway Immunology and Research Center, Ft. Pierce
1265 Union Avenue, 8 East, Memphis
Faculty of Medicine, Khon Kaen University, Khon Kaen
Hospital Universitario Virgen del Rocío, Seville
Universitätsklinikum Essen, Klinik für Dermatologie und Venerologie, Essen
Be Well Medical Center, Berkley
Universitätsklinikum Frankfurt, Medizinische Klinik II, Frankfurt am Main
Howard Brown Health Center, Chicago
Northstar Healthcare, Chicago
Southampton Healthcare, Inc., St Louis
Hôpital Saint-Louis, Paris
Hôpital Saint-Antoine, Paris
Hôpital Bichat-Claude Bernard, Paris
AIDS Arms, Inc. DBA Prism Health North Texas, Dallas
North Texas Infectious Diseases Consultants, P.A., Dallas
DCOL Center for Clinical Research, Longview
The Crofoot Research Center, INC., Houston
St Hope Foundation, Bellaire
Central Texas Clinical Research, Austin
Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City
Kaohsiung Veterans General Hospital, Kaohsiung City
Ruane Clinical Research Group Inc, Los Angeles
Mills Clinical Research, Los Angeles
Eisenhower Health Center at Rimrock, Palm Springs
One Community Health, Sacramento
Tokyo Medical University Hospital, Tokyo
Center Hospital of the National Center for Global Health and Medicine, Tokyo
Yale University; School of Medicine, New Haven
The Miriam Hospital, Providence
Vancouver ID Research and Care Centre Society, Vancouver
Maple Leaf Research/Maple Leaf Medical Clinic, Toronto
Clinique de médecine urbaine du Quartier Latin, Montreal
The Ottawa Hospital, Ottawa
U.O.C. IMMUNODEFICIENZE VIRALI - Istituto Nazionale Malattie Infettive Lazzaro Spallanzani IRCCS, Roma
U.O.C. Malattie Infettive - Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome
National Hospital Organization Nagoya Medical Center, Nagoya
National Hospital Organization Osaka National Hospital, Osaka
Hospital Universitari Germans Trías i Pujol, Badalona
Hospital Clinic de Barcelona, Barcelona
Lead Sponsor
Gilead Sciences
INDUSTRY