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

StatusRecruiting
PhasePhase 2
Started2026-06-15
View on ClinicalTrials.gov ↗

Amendment history

2026-09-03
Study Status, Contacts/Locations v3
Trial sites expanded: 36 → 55 locations
2026-08-04
Study Status, Contacts/Locations v2
Trial sites expanded: 3 → 36 locations
2026-07-09
Study Status, Outcome Measures, Contacts/Locations, References v1
Recruitment opened
Trial sites expanded: 0 → 3 locations
Start dateestimated 2026-06→confirmed 2026-06-15
Secondary endpoints14 entries, revised
Part B: Proportion of Participants WthWith HIV-1 RNA < 50 Copies/mL at Week 26 as Determined by the US FDA Snapshot Algorithm
2026-06-08
Original filing
Gilead Sciences
107 trials monitored
See 8 trials at risk
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.
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 2026-09-04