A Study of GS-3242 in Combination With Lenacapavir Versus Biktarvy in Virologically Suppressed People With HIV-1

Recruiting now · Phase 2

Conditions studied: HIV-1-infection

In brief

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.

Key facts

Study ID

NCT07645287

Run by

Gilead Sciences

People needed

175

Starts

2026-06-15

Expected to finish

2033-04-01

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

• Clinical Research Puerto Rico — San Juan, PR, Puerto Rico (enrolling)
• Optimus Medical Group — San Francisco, California, United States (enrolling)
• University of California San Francisco, Community and Clinical Research Center — San Francisco, California, United States (enrolling)
• Midland Florida Clinical Research Center, LLC — DeLand, Florida, United States (enrolling)
• CAN Community Health Fort Lauderdale — Fort Lauderdale, Florida, United States (enrolling)
• Midway Immunology and Research Center — Ft. Pierce, Florida, United States (enrolling)
• AIDS Healthcare Foundation -Coconut Grove — Miami, Florida, United States (enrolling)
• AHF - Pensacola — Pensacola, Florida, United States (enrolling)
• CAN Community Health Inc. — Sarasota, Florida, United States (enrolling)
• Triple O Research Institute, PA — West Palm Beach, Florida, United States (enrolling)
• Metro Infectious Disease Consultants, P.L.L.C. — Decatur, Georgia, United States (enrolling)
• Mercer University, Department of Internal Medicine — Macon, Georgia, United States (enrolling)
• Chatham County Health Department — Savannah, Georgia, United States (enrolling)
• Be Well Medical Center — Berkley, Michigan, United States (enrolling)
• KC CARE Health Center — Kansas City, Missouri, United States (enrolling)
• Southampton Community Healthcare — St Louis, Missouri, United States (enrolling)
• ID care — Hillsborough, New Jersey, United States (enrolling)
• South Jersey Infectious Disease — Somers Point, New Jersey, United States (enrolling)
• AXCES Research Group, LLC — Santa Fe, New Mexico, United States (enrolling)
• Brooklyn Clinical Research — Brooklyn, New York, United States (enrolling)
• Rosedale Health and Wellness — Huntersville, North Carolina, United States (enrolling)
• Philadelphia FIGHT Community Health Centers, Jonathan Lax Treatment Center — Philadelphia, Pennsylvania, United States (enrolling)
• Central Texas Clinical Research — Austin, Texas, United States (enrolling)
• St. Hope Foundation — Bellaire, Texas, United States (enrolling)
• Prism Health North Texas — Dallas, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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