A Study of GS-3242 in Combination With Lenacapavir Versus Biktarvy in Virologically Suppressed People With HIV-1 (NCT07645287)
A Phase 2 Randomized, Active-Controlled Study Evaluating the Safety and Efficacy of an Injectable Regimen of GS-3242 in Combination With Lenacapavir Versus Biktarvy (Bictegravir/Emtricitabine/Tenofovir Alafenamide) in Virologically Suppressed People With HIV-1
🩺 Plain-English Summary (8th-Grade Level)
The study will have two parts: Part A and Part B. In Part A, the goal of the study is to compare the effectiveness of switching to the study drugs GS-3242 plus Lenacapavir (LEN) versus continuing Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF)), in virologically suppressed people with HIV-1 (PWH) in treatment Group 1, 2 and 3 at Week 35. In Part B the goal of the study is to compare the effectiveness of switching to the study drugs, GS-3242 and LEN versus continuing B/F/TAF in Groups 4 and 3 at Week 26. The primary objective of part A is to evaluate the efficacy of switching to intramuscular (IM) GS-3242 plus IM LEN versus continuing on B/F/TAF PWH who are virologically suppressed in treatment Groups 1, 2, and 3 at Week 35 and Part B is to evaluate the efficacy of switching to IM GS-3242 plus IM LEN versus continuing on B/F/TAF in PWH who are virologically suppressed in Treatment Groups 4 and 3 at Week 26.
Who can join: Review the eligibility criteria below.
Location: Pacific Oak Medical Group — Beverly Hills, California
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 (36 Sites)
Showing the first 25 of 36 sites.
- Pacific Oak Medical Group — Beverly Hills, California
- Optimus Medical Group — San Francisco, California
- University of California San Francisco, Community and Clinical Research Center — San Francisco, California
- Midland Florida Clinical Research Center, LLC — DeLand, Florida
- CAN Community Health Fort Lauderdale — Fort Lauderdale, Florida
- Midway Immunology and Research Center — Ft. Pierce, Florida
- AIDS Healthcare Foundation -Coconut Grove — Miami, Florida
- AHF - Pensacola — Pensacola, Florida
- CAN Community Health Inc. — Sarasota, Florida
- Triple O Research Institute, PA — 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
- Southampton Community Healthcare — St Louis, Missouri
- ID care — Hillsborough, New Jersey
- South Jersey Infectious Disease — Somers Point, New Jersey
- AXCES Research Group, LLC — Santa Fe, New Mexico
- Brooklyn Clinical Research — Brooklyn, New York
- Rosedale Health and Wellness — Huntersville, North Carolina
- Philadelphia FIGHT Community Health Centers, Jonathan Lax Treatment Center — Philadelphia, Pennsylvania
- Central Texas Clinical Research — Austin, Texas
- St. Hope Foundation — Bellaire, Texas
- Prism Health North Texas — Dallas, Texas
📞 Contact the Study Coordinator
Phone: 1-833-445-3230 (GILEAD-0)
Email: GileadClinicalTrials@gilead.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 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 of Oral Weekly Lepetegravir (Formerly GS-1720) and Lenacapavir Pacfosacil (Formerly GS-4182) Versus Biktarvy in People With HIV-1 Who Are Virologically Suppressed — Birmingham, Alabama
- 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.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.