Study of Oral Weekly GS-1720 and GS-4182 Compared With Biktarvy in People With HIV-1 Who Have Not Been Treated
Stopped early · Phase 2/Phase 3 · Has a placebo group
Conditions studied: HIV-1-infection
In brief
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.
Key facts
- Study ID
- NCT06613685
- Run by
- Gilead Sciences
- People needed
- 73
- Starts
- 2024-10-21
- Expected to finish
- 2026-03-16
- Last updated by the study team
- 2026-04-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- 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
- UAB 1917 Research Clinic — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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