Clinical Research Directory
Browse clinical research sites, groups, and studies.
Study of Oral Weekly GS-1720 and GS-4182 Compared With Biktarvy in People With HIV-1 Who Have Not Been Treated
Sponsor: Gilead Sciences
Summary
The goal of this clinical study is to learn more about the experimental drugs lepetegravir (formerly GS-1720) (an oral, long-acting integrase strand transfer inhibitor (INSTI)) and lenacapavir pacfosacil (formerly GS-4182) (a prodrug of Lenacapavir (LEN)); to compare the combination of lepetegravir and lenacapavir pacfosacil with the current standard-of-care treatment bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (Biktarvy), to see if the combination of lepetegravir and lenacapavir pacfosacil is safe and if it works for treating human immunodeficiency virus type 1 (HIV-1) infection in treatment-naive people with HIV-1 (PWH). This study has two phases: Phase 2 and Phase 3. The primary objectives of this study are: Phase 2: To evaluate the efficacy of oral weekly lepetegravir coadministered with lenacapavir pacfosacil versus continuing Biktarvy (BVY) in treatment-naive PWH at Week 24. Phase 3: To evaluate the efficacy of oral weekly lepetegravir/lenacapavir pacfosacil fixed-dose combination (FDC) tablet regimen versus continuing BVY in treatment-naive PWH at Week 48.
Official title: An Operationally Seamless Phase 2/3, Randomized, Active-Controlled Study Evaluating the Safety and Efficacy of an Oral Weekly Regimen of GS-1720 in Combination With GS-4182 Versus Biktarvy in Treatment-Naive People With HIV-1
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
73
Start Date
2024-10-21
Completion Date
2026-03-16
Last Updated
2026-04-15
Healthy Volunteers
No
Conditions
Interventions
lepetegravir
Tablets administered orally without regard to food
lenacapavir pacfosacil
Tablets administered orally without regard to food
Bictegravir/emtricitabine/tenofovir alafenamide
Tablets administered orally without regard to food
lepetegravir/lenacapavir pacfosacil FDC
Tablets administered orally without regard to food
Placebo to Match BVY
Tablets administered orally without regard to food
Placebo to Match GS1720/GS-4182 FDC
Tablets administered orally without regard to food
Locations (58)
UAB 1917 Research Clinic
Birmingham, Alabama, United States
The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, United States
Mills Clinical Research
West Hollywood, California, United States
Georgetown University Medical School
Washington D.C., District of Columbia, United States
Midland Florida Clinical Research Center, LLC
DeLand, Florida, United States
Midway Immunology and Research Center
Ft. Pierce, Florida, United States
Floridian Clinical Research, LLC
Miami Lakes, Florida, United States
Orlando Immunology Center
Orlando, Florida, United States
Triple O Research Institute, P.A.
West Palm Beach, Florida, United States
Emory University Hospital Midtown Infectious Disease Clinic
Atlanta, Georgia, United States
Mercer University, Department of Internal Medicine
Macon, Georgia, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Saint Michael's Medical Center
Newark, New Jersey, United States
NYU Langone Health Vaccine Center
New York, New York, United States
Medical University of South Carolina (MUSC) Research Nexus
Charleston, South Carolina, United States
St Hope Foundation, Inc.
Bellaire, Texas, United States
Prism Health North Texas, Aids Arms
Dallas, Texas, United States
North Texas Infectious Diseases Consultants, PA
Dallas, Texas, United States
Texas Centers for Infectious Disease Associates
Fort Worth, Texas, United States
UT Health San Antonio
San Antonio, Texas, United States
MultiCare Rockwood Main Clinic
Spokane, Washington, United States
Clinique Médicale L'Actuel
Montreal, Canada
Chronic Viral Illness Service / McGill University Health Centre
Montreal, Canada
Ottawa Hospital Research Institute
Ottawa, Canada
Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik I, Immunologische Studienambulanz
Bonn, Germany
Universitätsmedizin Essen, Universitätsklinikum Essen, Klinik für Dermatologie, Venerologie und Allergologie, HPSTD-Ambulanz
Essen, Germany
ICH Study Center GmbH & Co. KG
Hamburg, Germany
Medizinische Hochschule Hannover, Klinik für Rheumatologie und Immunologie, Gebäude K14
Hanover, Germany
Klinikum rechts der Isar, Technische Universität München, Klinik und Poliklinik für Innere Medizin II
München, Germany
Wojewódzki Szpital Obserwacyjno-Zakaźny im. Tadeusza Browicza
Bydoszcz, Poland
Punkt Zdrowia
Gdansk, Poland
Samodzielny Publiczny Wojewódzki Szpital Zespolony w Szczecinie
Szczecin, Poland
Unidade Local de Saude de Amadora Sinatra EPE, Hospital Prof. Doutor Fernando Fonseca
Amadora, Portugal
Unidade Local de Saúde de Lisboa Ocidental E.P.E. - Hospital Egas Moniz
Lisbon, Portugal
Unidade Local de Saúde de Santo Maria E.P.E. - Hospital Santa Maria
Lisbon, Portugal
Unidade Local de Saúde de Santo António, E.P.E.
Porto, Portugal
Unidade Local de Saúde de São João E.P.E.
Porto, Portugal
HOPE Clinical Research
San Juan, PR, Puerto Rico
Proyecto ACTU
San Juan, PR, Puerto Rico
Institutul National De Boli Infectioase Prof. Dr. Matei Bals
Bucharest, Romania
Spitalul Clinic De Urgenta Prof Dr Agrippa Ionescu
Bucharest, Romania
Spitalul Clinic De Boli Infectioase Cluj-Napoca
Cluj-Napoca, Romania
Spitalul Clinic de Boli Infectioase Constanta
Constanța, Romania
Clinical Hospital of Infectious Diseases and Pneumophysiology Dr. Victor Babes Timisoara
Timișoara, Romania
JOSHA Research
Bloemfontein, South Africa
Durban International Clinical Research Site, Enhancing Care Foundation
Durban, South Africa
Synergy Biomed Research Institute
East London, South Africa
CRISMO Research Center
Germiston, South Africa
WITS RHI Research Centre
Johannesburg, South Africa
Clinical Research Institute of South Africa (CRISA)
KwaZulu-Natal, South Africa
FPD Ndevana Community Research Site
Ndevana, South Africa
The Aurum Institute Tembisa Clinic 4
Tembisa, South Africa
Hospital Clinic de Barcelona
Barcelona, Spain
Hospital Clinico San Carlos
Madrid, Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, Spain
Hospital Universitario Virgen de la Victoria
Málaga, Spain
Hospital Universitario Alvaro Cunqueiro
Pontevedra, Spain
Hospital Arnau de Vilanova de Valencia
Valencia, Spain