3,292
Participants
Start Date
June 28, 2021
Primary Completion Date
August 21, 2024
Study Completion Date
May 31, 2028
Oral Lenacapavir (LEN)
Tablets administered orally without regard to food
F/TDF
Tablets administered orally
Sub-cutaneous (SC) Lenacapavir (LEN)
Administered via SC injections
Placebo SC LEN
Administered via SC injections
PTM F/TDF
Tablets administered orally
PTM Oral LEN
Tablets administered orally
F/TAF (for US participants only)
F/TAF tablets administered orally once daily
The Aurum Institute: Pretoria Clinical Research Centre, Pretoria
Hospital General de Agudos JM Ramos Mejia, Buenos Aires
Fundacion Huesped, Buenos Aires
The Aurum Institute Tembisa CRC, Clinic 4, Tembisa
Wits Reproductive Health and HIV Institute (Wits RHI), Johannesburg
FPD-DTHF Ndevana Commuity Research Site, Vincent
"Instituto de Medicina Tropical Daniel Alcides Carrion, Facultad de Medicina Humana, UNMSM", Callao
Desmond Tutu Health Foundation, Cape Town
Icahn School of Medicine at Mount Sinai- Mount Sinai Downtown, New York
Institute of HIV Research and Innovation, Bangkok
King Chulalongkorn Memorial Hospital, Bangkok
The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), Thai Red Cross AIDS research Centre, Bangkok
Ramathibodi Hospital, Mahidol University, Bangkok
Bamrasnaradura Infectious Disease Institute, Nonthaburi
Via Libre, Lima
Asociacion Civil Impacta Salud y Educacion - Sede Barranco, Barranco
Asociacion Civil Impacta Salud y Educacion - Sede San Miguel, Lima
Penn Prevention Unit, Philadelphia
Philadelphia FIGHT Community Health Centers, Jonathan Lax Treatment Center, Philadelphia
Whitman-Walker Institute Inc., Washington D.C.
Washington Health Institute, Washington D.C.
Johns Hopkins University School of Medicine, Baltimore
Wake Forest University Health Sciences, Winston-Salem
Cone Health/Regional Center for Infectious Disease Research Center, Greensboro
NC TraCS Institute - CTRC; University of North Carolina at Chapel Hill, Chapel Hill
Prisma Health-Midlands Clinical Research Unit, Columbia
Medical University of South Carolina, Infectious Disease Clinic, Charleston
Prisma Health Internal Medicine Clinic, Greenville
The Hope Clinic at Emory University, Atlanta
Emory University, Atlanta
Emory University Hospital Midtown Infectious Disease Clinic, Atlanta
Orlando Immunology Center, Orlando
CAN Community Health, Miami Gardens
University of Miami Miller School of Medicine Division of Infectious Disease Research - Converge Miami, Miami
Therafirst Medical Center, Fort Lauderdale
Gary Richmond, MD, PA, Fort Lauderdale
CAN Community Health, Sarasota
Midway Immunology & Research Center, LLC, Ft. Pierce
UAB Sexual Health Research Clinic, Birmingham
Meharry Medical College Clinical and Transitional Research Center, Nashville
Methodist University Hospital/University of Tennessee Health Science Center, Clinical Research Center, Memphis
St Jude Children's Research Hospital, Memphis
Open Arms Healthcare Center, Jackson
Srinagarind Hospital, Khon Kaen University, Khon Kaen
Norton Infectious Disease Specialists, Louisville
Baptist Health Lexington, Lexington
The Ohio State University Wexner Medical Center, Columbus
Centro de Investigacion Farmaceutica Especializada de Occidente S.C., Guadalajara C.P.
University of Cincinnati, Cincinnati
Indiana University Infectious Diseases Research, Indianapolis
Be Well Medical Center, Berkley
Henry Ford Hospital, Detroit
Research Institute for Health Sciences, Chiang Mai University, Chiang Mai
RMR Core Center, Chicago
University of Illinois at Chicago, Department of Medicine, Division of Infectious Diseases, Project WISH, Chicago
Howard Brown Health Center, Chicago
KC CARE Health Center, Kansas City
LSU-CrescentCare Sexual Health Center- New Orleans Community Health Center, New Orleans
The Crofoot Research Center, INC, Houston
Central Texas Clinical Research, Austin
Centro San Vincente, El Paso
University of Colorado Clinical and Translational Research Centers (CTRC), Aurora
Ruane Clinical Research Group Inc., Los Angeles
UCLA CBAM Vine Street Clinic, Los Angeles
Charles R. Drew University of Medicine and Science (CDU) - Clinical Translational Research Center (CTRC), Los Angeles
Mills Clinical Research, Los Angeles
The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Los Angeles
UCSD Anti Viral Research Center, San Diego
BIOS Clinical Research, Palm Springs
Loma Linda University Clinical Trial Center Clinic, Loma Linda
Bridge HIV at the San Francisco Department of Public Health, San Francisco
Optimus Medical Group, San Francisco
Ofiice of Dr. Peter Shalit, MD, Seattle
Yale University, School of Medicine, New Haven
The Fenway Institute, Boston
St. Michael's Medical Center, Newark
South Jersey Infectious Disease, Somers Point
Instituto de Investigaciones Clinicas Mar del Plata, Buenos Aires
Unidade de Pesquisa Clinica em Vacinas (UPqVac) da Faculdade de Medicina da Universidade, Belo Horizonte - MG
Fundação Bahiana de Infectologia, Canela-Salvador
Fundação de Medicina Tropical Doutor Heitor Vieira Dourado / Fundação Medicina Tropical do Amazonas - FMT/IMT/AM, Manauas
Hospital General de Nova Iguaçu - HGNI, Nova Iguaçu
Grupo Hospitalar Conceição/ Hospital Nossa Senhora da Conceição S.A., Porto Alegre
Instituto Nacional de Infectologia Evandro Chagas / Fundação Oswaldo Cruz - INI FIOCRUZ, Rio de Janeiro
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo
Centro de Referência e Treinamento DST/AIDS, São Paulo
Center for Management and Research. SPDM-Paulista Association for the Development of Medicine-Hospital São Paulo/Federal, São Paulo
Asociacion Civil Selva Amazonica, Iquitos
Ararat Research Center, San Juan
Centro Ararat- San Juan, San Juan
Setshaba Research Centre, Soshanguvhe
Lead Sponsor
Gilead Sciences
INDUSTRY