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Study identifier: NCT07645287 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: HIV-1-infection  ·  Sponsor: Gilead Sciences

PhasePhase 2
Planned participants175
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Gilead Clinical Study Information Center  ·  1-833-445-3230 (GILEAD-0)  ·  GileadClinicalTrials@gilead.com

Always discuss trial participation with your own doctor first.

Locations (3)

Midway Immunology and Research CenterFt. Pierce, Florida, United StatesRecruiting
North Texas Infectious Disease Consultants, P.A.Dallas, Texas, United StatesRecruiting
Diagnostic Clinic of LongviewLongview, Texas, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT07645287