Weekly long-acting HIV-1 meds switch for people with undetectable virus

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 substudy of a master protocol evaluates the safety, tolerability, effectiveness, and pharmacokinetics of switching from daily bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) to weekly long-acting regimens (GS-3242 + lenacapavir) in virologically suppressed adults. Participants must have been on B/F/TAF for at least six months and have HIV-1 RNA less than 50 copies/mL, with a CD4 count of at least 200 cells/mm3. The primary endpoint is Week 24 virologic suppression compared between each LAO regimen and continued B/F/TAF. The study analyzes safety signals and PK profiles to inform tolerability and dosing feasibility. Enrolled sites are in Florida and Texas, led by Gilead Sciences.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* Individuals assigned male or female at birth, 18 years of age or older, able to understand and give written informed consent and comply with treatment and follow-up.
* Individuals assigned male or female at birth who are of childbearing potential and engage in heterosexual intercourse must agree to use approved method(s) of contraception.
* Negative serum pregnancy test at screening and negative urine test at enrollment.
* Receiving B/F/TAF for ≥ 6 months prior to screening.
* Documented plasma HIV-1 RNA \< 50 copies/mL for ≥ 6 months before and at screening.
* No 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) on available historical resistance reports.
* CD4 ≥ 200 cells/mm\^3 at screening

Key Exclusion Criteria:

* Plans to breastfeed during the study period and 60 days following the last dose of study intervention.
* History of virologic failure while on an integrase strand-transfer inhibitor-based regimen.
* Creatinine clearance according to the Cockcroft-Gault formula \< 60 mL/min.

Where it's running

• Midway Immunology and Research Center
  Ft. Pierce, Florida, United States Recruiting
• The Crofoot Research Center, INC
  Houston, Texas, United States Recruiting

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.