Clinical Trial

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

Recruiting Phase 2
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Summary
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.
Protocol Amendment History 3 changes
notable Trial sites expanded: 3 -> 36 locations 2026-08-07
critical Recruitment opened 2026-07-11
notable Trial sites expanded: 0 -> 3 locations 2026-07-11
Trial Details
NCT Number NCT07645287
Lead Sponsor Gilead Sciences
Conditions HIV-1-infection
Enrollment 175 participants
Start Date 2026-06-15
Primary Completion 2027-08 (estimated)
Study Completion 2033-04 (estimated)
Updated on ClinicalTrials.gov 2026-08-06