Substudy-01: A Study of Long-Acting HIV-1 Treatments Taken by Mouth in People With HIV-1 With Undetectable Virus Levels
Gilead Sciences · NCT07841990
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 2
- Target enrollment
- 125
- US sites recruiting
- 2
- Study start
- October 1, 2026
- Record last updated
- October 23, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: B/F/TAF; GS-3242; Lenacapavir
Conditions: HIV-1 Infection
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
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.
Recruiting US locations
Midway Immunology and Research Center
Ft. Pierce, FL 34982
The Crofoot Research Center, INC
Houston, TX 77098
Study contacts (from the official record)
- Gilead Clinical Study Information Center · 1-833-445-3230 (GILEAD-0) · GileadClinicalTrials@gilead.com