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A Study of GS-3242 and Lenacapavir for HIV-1

This study is for people with HIV-1 who are currently taking Biktarvy and have successfully kept their viral load (HIV-1 RNA) very low for at least six months. It aims to see if switching to a new combination of medicines, GS-3242 and Lenacapavir, is as effective as continuing Biktarvy. GS-3242 and Lenacapavir can be given as pills or injections. The study will compare how well these different treatments keep your HIV-1 RNA below 50 copies/mL after 26 or 35 weeks. About 175 people are expected to join this study.

Study design
This is an interventional study comparing different treatment groups. It plans to enroll about 175 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study measures effectiveness at Week 26 or Week 35, depending on the part of the study you are in.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07645287

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Gilead Sciences
~175 participants
Updated 2026-07-10 on ClinicalTrials.gov
What's tested:GS-3242 TabletGS-3242 InjectionLenacapavir TabletLenacapavir InjectionB/F/TAF

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part A: Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 35 as Determined by the United States (US) Food and Drug Administration (FDA) Snapshot Algorithm
Measured over Week 35
+1 more outcome measured

Conditions

HIV-1-infection

Explore related trials

HIV Infection

Where it's being run

3 sites across 2 states
Texas2
Florida1

Study leadership

  • Gilead Study Director · STUDY_DIRECTOR · Gilead Sciences

Who to contact

Gilead Clinical Study Information Center
[email protected]
1-833-445-3230 (GILEAD-0)
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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).

Exclusion

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.

What this trial measures

  • Part A: Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 35 as Determined by the United States (US) Food and Drug Administration (FDA) Snapshot AlgorithmWeek 35
  • Part B: Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 26 as Determined by the US FDA Snapshot AlgorithmWeek 26