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NCT07645287PHASE2Recruiting

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

Gilead Sciences

Start Date

6/15/2026

Completion Date

4/1/2033

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.

Eligibility Criteria

Age Range: 18 years to No maximum

Key Inclusion Criteria: * Documented human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) \< 50 copies/mL for ≥ 6 months before screening. * Plasma HIV-1 RNA levels \< 50 copies/mL at screening. * Receiving bictegravir/emtricitabine/tenofovir alafenamide (coformulated; Biktarvy®) (B/F/TAF) for ≥ 6 months prior to screening. * No documented resistance to GS-3242 (integrase mutation Q148H/K/R plus at least 2 of the following integrase mutations: L74I/M, T97A, E138A/K/T, or G140A/C/S). Key Exclusion Criteria: * Prior use of, or exposure to GS-3242 or LEN. * History of virologic failure while on an integrase strand transfer inhibitor (INSTI)-based regimen. * Prior use of any long-acting parenteral antiretroviral therapy (ART) medications such as monoclonal antibodies or broadly neutralizing antibodies targeting HIV-1, injectable cabotegravir (including oral cabotegravir lead-in), or injectable rilpivirine. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Interventions

DRUG

GS-3242 Tablet

DRUG

GS-3242 Injection

DRUG

Lenacapavir Tablet

DRUG

Lenacapavir Injection

DRUG

B/F/TAF

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Conditions

HIV-1-infection

Locations

Midway Immunology and Research Center

Ft. Pierce, Florida 34982

United States

North Texas Infectious Disease Consultants, P.A.

Dallas, Texas 75246

United States

Diagnostic Clinic of Longview

Longview, Texas 75605

United States