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Substudy-01: A Study of Long-Acting HIV-1 Treatments Taken by Mouth in People With HIV-1 With Undetectable Virus Levels

RecruitingPhase 2Ages 18 Years - anyAllGilead Sciences
NCT07841990 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Master Protocol: The main goal of this master clinical study is to evaluate the safety, tolerability, efficacy, and pharmacokinetic (PK) of long-acting oral (LAO) regimens in people with HIV-1 (PWH). The main goal of this Substudy-01 is to assess the safety, tolerability, effectiveness, and PK of switching to weekly LAO regimens, including GS-3242 + LEN, versus continuing on once daily oral bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF; coformulated; Biktarvy®) in PWH with controlled HIV infection, B/F/TAF for at least 6 months prior to study start. The primary objective is to evaluate the efficacy of switching to each LAO regimen versus continuing B/F/TAF in virologically suppressed PWH at Week 24.

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📋 Eligibility rules (as published)
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.
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What it tests

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

2 sites
Midway Immunology and Research Center
Ft. Pierce, United States
The Crofoot Research Center, INC
Houston, United States
🤝 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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