NCT07115368

Study of GS-1219 in Participants With HIV-1

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-04: GS-1219

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 4 (actual)
• 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 (GSUS-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-544-5905-04 is to learn more about study drug GS-1219, safety, pharmacokinetics (PK) (how GS-1219 is absorbed, modified, distributed, and removed from the body of the participants), and antiviral activity in Participants With HIV-1.

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-1219	Administered orally
DRUG	BVY	Administered orally
DRUG	Standard of Care	Antiretroviral therapy, administered orally non nonnucleoside reverse transcriptase inhibitor (NNRTIs), examples: ABC/ DTG/3TC; DTG plus (TAF or TDF) plus (FTC or 3TC)

Timeline

• Start date: 2025-08-11
• Primary completion: 2025-09-19
• Completion: 2025-10-02
• First posted: 2025-08-11
• Last updated: 2025-10-21

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated drug study