Study of Oral Weekly Lepetegravir (Formerly GS-1720) and Lenacapavir Pacfosacil (Formerly GS-4182) Versus Biktarvy in People With HIV-1 Who Are Virologically Suppressed
Running, not enrolling · 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 and lenacapavir pacfosacil; to compare the combination of lepetegravir and lenacapavir pacfosacil with the current standard-of-care treatment bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF, BVY), 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. This study has two phases: Phase 2 and Phase 3. The primary objectives of this study are: Phase 2: To evaluate the efficacy of switching to oral weekly lepetegravir in combination with lenacapavir pacfosacil versus continuing BVY in virologically suppressed people with HIV-1 (PWH) at Week 24. Phase 3: To evaluate the efficacy of switching to oral weekly lepetegravir /lenacapavir pacfosacil Fixed-dose combination (FDC) tablet regimen versus continuing BVY in virologically suppressed PWH at Week 48.
Key facts
- Study ID
- NCT06544733
- Run by
- Gilead Sciences
- People needed
- 675
- Starts
- 2024-08-20
- Expected to finish
- 2029-06-01
- Last updated by the study team
- 2026-04-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- UAB 1917 Research Clinic — Birmingham, Alabama, United States
- Pacific Oaks Medical Group — Beverly Hills, California, United States
- Ruane Clinical Research Group — Los Angeles, California, United States
- Mills Clinical Research — Los Angeles, California, United States
- BIOS Clinical Research — Palm Springs, California, United States
- UCSF Division of HIV, Infectious Diseases & Global Medicine — San Francisco, California, United States
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center — Torrance, California, United States
- Georgetown University Medical Center — Washington D.C., District of Columbia, United States
- Midland Florida Clinical Research Center, LLC — DeLand, Florida, United States
- CAN Community Health — Fort Lauderdale, Florida, United States
- Midway and Immunology Research Center — Ft. Pierce, Florida, United States
- AIDS Healthcare Foundation - The Kinder Medical Group — Miami, Florida, United States
- Floridian Clinical Research — Miami Lakes, Florida, United States
- Orlando Immunology Center — Orlando, Florida, United States
- CAN Community Health — Sarasota, Florida, United States
- Triple O Research Institute, P.A. — West Palm Beach, Florida, United States
- Metro Infectious Disease Consultants, P.L.L.C. — Decatur, Georgia, United States
- Mercer University, Department of Internal Medicine — Macon, Georgia, United States
- Chatham County Health Department — Savannah, Georgia, United States
- Be Well Medical Center — Berkley, Michigan, United States
- KC CARE Health Center — Kansas City, Missouri, United States
- Saint Michael's Medical Center — Newark, New Jersey, United States
- AXCES Research Group, LLC — Santa Fe, New Mexico, United States
- NewYork-Presbyterian Queens — Flushing, New York, United States
- NYU Langone Health Vaccine Center — New York, New York, United States
Full record on ClinicalTrials.gov
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