Switch to GS-3242 plus Lenacapavir vs Biktarvy in virologically suppressed people with HIV-1

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2 interventional trial with two parts. Part A compares intramuscular GS-3242 plus Lenacapavir against continuing B/F/TAF in several treatment groups at Week 35. Part B compares the same switching strategy against B/F/TAF in groups 3 and 4 at Week 26. Primary goals are to assess efficacy of switching in maintaining virologic suppression in people on a stable regimen. Interventions include GS-3242 and Lenacapavir in tablet and injection forms, plus B/F/TAF as the comparator. Eligible participants have HIV-1 RNA <50 copies/mL for at least 6 months and on B/F/TAF for ≥6 months, with specific resistance exclusions. Exclusions include prior exposure to GS-3242 or Lenacapavir and history of INSTI failure or prior long-acting ART exposure. The study is sponsored by Gilead Sciences with clinical sites in Arizona and California.

Why it matters

Who can join: the full rules

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.

Where it's running

• Pacific Oak Medical Group
  Beverly Hills, California, United States Recruiting
• Ruane Clinical Research Group Inc.
  Los Angeles, California, United States Recruiting
• Optimus Medical Group
  San Francisco, California, United States Recruiting
• University of California San Francisco, Community and Clinical Research Center
  San Francisco, California, United States Recruiting
• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
  Torrance, California, United States Recruiting
• Vivent Health
  Denver, Colorado, United States Recruiting

+9 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Gilead Clinical Study Information Center
• Email: GileadClinicalTrials@gilead.com
• Phone: 1-833-445-3230 (GILEAD-0)

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.