689
Participants
Start Date
August 16, 2022
Primary Completion Date
September 29, 2025
Study Completion Date
July 31, 2028
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"
Sefako Makgatho Health Sciences University, Ga-Rankuwa
Hospital General de Agudos J.M Ramon Mejia, Buenos Aires
Fundación Huésped, Buenos Aires
Helios Salud, Buenos Aires
St.Vincent's Hospital Sydney, Darlinghurst
Holdsworth House Medical Practice, Sydney
Taylor Square Private Clinic, Darlinghurst
Ezintsha, Johannesburg
Alfred Health, Melbourne
Hospital Universitario Virgen del Rocio, Seville
CHU Nice-Hôpital l'Archet, Nice
Desmond Tutu Health Foundation Clinical Trials Unit, Cape Town
Ricky K. Hsu, MD, PC, New York
ASL Città di Torino, Torino
zibp Zentrum für Infektiologie Berlin Prenzlauer Berg GmbH, Berlin
New York Presbyterian Hospital, Flushing
Philadelphia FIGHT, Philadelphia
IRCCS Ospedale San Raffaele, Milan
ICH Study Center GmbH & Co. KG, Hamburg
ASST Fatebenefratelli Sacco, Milan
Far Eastern Memorial Hospital, New Taipei City
University of North Carolina - Chapel Hill, Chapel Hill
East Carolina University, Greenville
Hospital Ramon y Cajal, Madrid, Madrid
Hospital Clinico San Carlos, Madrid
Hospital Universitario La Paz, Madrid
Medical University of South Carolina (MUSC) Research NEXUS, Charleston
Atlanta ID Group, Atlanta
Mercer University School of Medicine, Macon
Midland Florida Clinical Research Center, LLC, DeLand
Orlando Immunology Center, Orlando
Therapeutic Concepts, PA, Orlando
Taoyuan General Hospital, Taoyuan
Floridian Clinical Research, Miami Lakes
Schiff Center for liver Diseases/University of Miami, Miami
Therafirst Medical Centers, Fort Lauderdale
Gary Richmond, MD, PA, Inc., Fort Lauderdale
Triple O Research Institute PA, West Palm Beach
Midway Immunology & Research Center, LLC, Ft. Pierce
Chungnam National University Hospital, Daejeon
Azienda Ospedaliero-Universitaria di Modena, Modena
Kyungpook National University Hospital, Daegu
Be Well Medical Center, Berkeley
Universitatsklinikum Bonn, Bonn
Infektio Research GmbH & Co.KG, Frankfurt
Howard Brown Health Center, Chicago
Southampton Healthcare, Inc., St Louis
Kansas City Care Clinic, Kansas City
Hospital Saint Louis, Paris
Groupe Hospitalier Bichat Claude Bernard, Paris
AIDS Arms, Inc., DBA Prism Health North Texas, Dallas
North Texas Infectious Diseases Consultants, Dallas
Diagnostic Clinic of Longview - Center for Clinical Research, Longview
Höpital de la Pitié Salpêtrière, Paris
Texas Centers for Infectious Disease Associates, Fort Worth
Gordon E. Crofoot MD PA, Houston
St. Hope Foundation, Bellaire
Central Texas Clinical Research, Austin
Denver Health Medical Center, Denver
Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City
Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City
AXCES Research Group, Santa Fe
Ruane Clinical Research Group, Inc, Los Angeles
The Men's Health Foundation, West Hollywood
Pacific Oaks Medical Group, Beverly Hills
Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical Center, Torrance
University of California San Diego (UCSD), San Diego
Bios Clinical Research, Palm Springs
Alta Bates Summit Medical Center, Summit Campus, East Bay Advanced Care, Oakland
Peter Shalit, MD, Seattle
Yale University; School of Medicine; AIDS Program, New Haven
Saint Michael's Medical Center, Newark
Chronic Viral Illness Service / McGill University Health Centre (MUHC), Decarie Montreal
Clinique Medicale du Quartier Latin, Montreal
The Ottawa Hospital - General Campus, Ottawa
ID Clinic, Regina
Maple Leaf Research, Toronto
Spectrum Health, Vancouver
Instituto Dominicano de Estudio Virologicos - IDEV, Santo Domingo
MVZ München am Goetheplatz, München
National Hospital Organization Nagoya Medical Center, Nagoya
"Istituto Nazionale Malattie Infettive Lazzaro Spallanzani IRCCS", Roma
National Hospital Organization Osaka National Hospital, Osaka
Center Hospital of the National Center for Global Health and Medicine, Tokyo
Hope Clinical Research, San Juan
Proyecto ACTU, San Juan
Yonsei University Severance Hospital, Seoul
The Catholic University of Korea Seoul St. Mary's Hospital, Seoul
Hospital Clinic Provincial de Barcelona, Barcelona
Department of HIV & Sexual Medicine, Birmingham
Brighton and Sussex University Hospitals NHS Trust, Brighton
Barts Health NHS Trust, London
HIV medicine and infectious diseases, London
St.Stephen's AIDS Trust, Clinical Trials Unit, 1st Floor, St.Stephen's Centre, London
Lead Sponsor
Gilead Sciences
INDUSTRY