NCT07001319

Study of GS-3242 in Participants With HIV-1; Substudy-05

An Umbrella Phase 1b, Open-label, Multi-Cohort Study to Evaluate Safety, Pharmacokinetics, and Antiviral Activity of Novel Antiretrovirals in Participants With HIV-1 Substudy-05: GS-3242

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study is part of a master study. The goal of master protocol (GS-US-544-5905, NCT05585307) is to learn how novel antiretrovirals (medicines that stop the virus from multiplying) affect the human immunodeficiency virus-1 (HIV-1) infection in people living with HIV (PWH). Substudy GS-US-544-5905-05 is to learn more about the study drug GS-3242 in PWH.

Detailed description

To refer master study protocol (GS-US-544-5905), refer to NCT05585307 on https://clinicaltrials.gov/

Conditions

• HIV-1-infection

Interventions

Type	Name	Description
DRUG	GS-3242	Administered orally
DRUG	BVY	Administered orally
DRUG	Standard of Care	Antiretroviral therapy, administered orally Non-NNRTIs, examples: ABC/ DTG/3TC; DTG plus (TAF or TDF) plus (FTC or 3TC)

Timeline

• Start date: 2025-05-29
• Primary completion: 2026-04-01
• Completion: 2027-02-01
• First posted: 2025-06-03
• Last updated: 2026-03-05

Locations

28 sites across 3 countries: United States, Mexico, Thailand

Regulatory

• FDA-regulated drug study