Gilead study of GS-3242 with Lenacapavir for people starting HIV treatment compared with Biktarvy

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 2/3 interventional trial evaluating an injectable regimen of GS-3242 plus Lenacapavir versus the standard oral Biktarvy in treatment-naive adults with HIV-1. Phase 2 includes Part A and Part B to compare short-term efficacy at 26–35 weeks across multiple treatment groups. Phase 3 follows to assess long-term effectiveness at 52 weeks. Interventions include GS-3242 and Lenacapavir in both tablet and injectable forms alongside B/F/TAF, with primary endpoints focused on virologic efficacy. Eligibility requires HIV-1 RNA ≥ 500 copies/mL at screening and no prior LEN or GS-3242 exposure, among other criteria, and several sites are involved in the United States.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* HIV-1 ribonucleic acid (RNA) ≥ 500 copies/mL at screening.
* Antiretroviral (ARV) treatment-naive, except for prior use of oral daily pre-exposure prophylaxis (PrEP) or postexposure prophylaxis (PEP) up to 1 month prior to screening.

Key Exclusion Criteria:

* Prior usage of, or exposure to LEN or GS-3242
* Prior use of any long-acting parenteral ARV 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

• Lundquist Inst Biomedical Innovation Harbor-UCLA
  Torrance, California, United States Recruiting
• Yale University; School of Medicine; AIDS Program
  New Haven, Connecticut, United States Recruiting
• Midway Immunology and Research Center
  Ft. Pierce, Florida, United States Recruiting
• Floridian Clinical Research, LLC
  Miami Lakes, Florida, United States Recruiting
• Orlando Immunology Center, PA
  Orlando, Florida, United States Recruiting
• Triple O Research Institute, P.A.
  West Palm Beach, Florida, United States Recruiting

Study contacts

• Study coordinator: Gilead Clinical Study Information Center
• Email: leadClinicalTrials@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.