RecruitingPhase 2NCT07645287

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

A Phase 2 Randomized, Active-Controlled Study Evaluating the Safety and Efficacy of an Injectable Regimen of GS-3242 in Combination With Lenacapavir Versus Biktarvy (Bictegravir/Emtricitabine/Tenofovir Alafenamide) in Virologically Suppressed People With HIV-1


Sponsor

Gilead Sciences

Enrollment

175 participants

Start Date

Jun 15, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called B/F/TAF, a drug called GS-3242 Injection, and others for people with hiv-1-infection. The study is currently recruiting participants at 3 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGS-3242 Tablet

Administered orally

DRUGGS-3242 Injection

Administered intramuscularly (IM)

DRUGLenacapavir Tablet

Administered orally

DRUGLenacapavir Injection

Administered IM

DRUGB/F/TAF

Administered orally


Locations(3)

Midway Immunology and Research Center

Ft. Pierce, Florida, United States

North Texas Infectious Disease Consultants, P.A.

Dallas, Texas, United States

Diagnostic Clinic of Longview

Longview, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT07645287


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