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

NCT07841990 · tracked via the Priya Life Science USA tracker

Sponsor

Gilead Sciences

Phase

Phase 2

Started

2026-10-01

Last updated

2026-10-23

Condition(s) studied

HIV-1 Infection

Investigational drug(s) / intervention(s)

B/F/TAF →GS-3242 →Lenacapavir →

B/F/TAF: Tablet administered orally

GS-3242: Tablet administered orally

Lenacapavir: Tablet administered orally

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Proportion of Participants With HIV-1 Ribonucleic Acid (RNA) ≥ 50 copies/mL at Week 24 as Determined by the United States (US) Food and Drug Administration (FDA)-Defined Snapshot Algorithm — Week 24

Trial sites (2)

Facility	City	Region	Status
Midway Immunology and Research Center	Ft. Pierce	Florida	Recruiting
The Crofoot Research Center, INC	Houston	Texas	Recruiting

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Other trials for the same condition

Study Evaluating the Safety and Efficacy of Islatravir in Combination With Lenacapavir in Virologically Suppressed People With HIV Active, not recruiting

Long Term Follow up for the Detection of Delayed Adverse Events in Cal-1 Recipients Active, not recruiting

Open-label, Follow-up of Doravirine/Islatravir (DOR/ISL 100 mg/0.75mg) for Participants With Human Immunodeficiency Virus-1 (HIV-1) Infection (MK-8591A-033) Active, not recruiting

A Study of Teropavimab and Zinlirvimab in Combination With Capsid Inhibitor Lenacapavir in Virologically Suppressed Adults With HIV-1 Infection Active, not recruiting

A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Virologically Suppressed on Antiretroviral Therapy (ART) (MK-8591A-051) Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07841990 on ClinicalTrials.gov ↗ ← All trials in the USA