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

RecruitingPhase 2Ages 18 Years - anyAllGilead Sciences
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • GS-3242 Tablet
  • GS-3242 Injection
  • Lenacapavir Tablet
  • Lenacapavir Injection
  • B/F/TAF
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Where

57 sites
Pueblo Family Physicians
Phoenix, United States
Pacific Oak Medical Group
Beverly Hills, United States
Ruane Clinical Research Group Inc.
Los Angeles, United States
Optimus Medical Group
San Francisco, United States
University of California San Francisco, Community and Clinical Research Center
San Francisco, United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, United States
Mills Clinical Research
West Hollywood, United States
University of Colorado Clinical and Translational Research Center
Aurora, United States

…and 49 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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