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 (NCT06544733)
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 Virologically Suppressed People With HIV-1
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: UAB 1917 Research Clinic — Birmingham, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (39 Sites)
Showing the first 25 of 39 sites.
- UAB 1917 Research Clinic — Birmingham, Alabama
- Pacific Oaks Medical Group — Beverly Hills, California
- Ruane Clinical Research Group — Los Angeles, California
- Mills Clinical Research — Los Angeles, California
- BIOS Clinical Research — Palm Springs, California
- UCSF Division of HIV, Infectious Diseases & Global Medicine — San Francisco, California
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center — Torrance, California
- Georgetown University Medical Center — Washington D.C., District of Columbia
- Midland Florida Clinical Research Center, LLC — DeLand, Florida
- CAN Community Health — Fort Lauderdale, Florida
- Midway and Immunology Research Center — Ft. Pierce, Florida
- AIDS Healthcare Foundation - The Kinder Medical Group — Miami, Florida
- Floridian Clinical Research — Miami Lakes, Florida
- Orlando Immunology Center — Orlando, Florida
- CAN Community Health — Sarasota, Florida
- Triple O Research Institute, P.A. — West Palm Beach, Florida
- Metro Infectious Disease Consultants, P.L.L.C. — Decatur, Georgia
- Mercer University, Department of Internal Medicine — Macon, Georgia
- Chatham County Health Department — Savannah, Georgia
- Be Well Medical Center — Berkley, Michigan
- KC CARE Health Center — Kansas City, Missouri
- Saint Michael's Medical Center — Newark, New Jersey
- AXCES Research Group, LLC — Santa Fe, New Mexico
- NewYork-Presbyterian Queens — Flushing, New York
- NYU Langone Health Vaccine Center — New York, New York
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in HIV-1-Infection
- Study of Bictegravir/Lenacapavir in Children and Adolescents With HIV-1 — Washington D.C., District of Columbia
- Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen — Berkeley, California
- Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed People With HIV-1 — Birmingham, Alabama
- Impact of HIV-1 and Aging on Mucosal Vaccine Responses — Aurora, Colorado
- Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy — Phoenix, Arizona
Explore by condition: All HIV-1-Infection clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.