NCT05585307

Study of Novel Antiretrovirals 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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Master protocol: The goal of this master clinical trial study 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-01 (GS-US-544-5905-01) will evaluate bavtavirine in PWH. Substudy-02 (GS-US-544-5905-02) will evaluate GS-1720 in PWH. Substudy-03 (GS-US-544-5905-03) will evaluate GS-6212 in PWH.

Detailed description

This umbrella study will begin with a substudy of bavtavirine (Substudy-01), and later substudies GS-1720 (Substudy-02) and GS-6212 (Substudy-03) will be added. Substudies evaluating additional study drugs will be added in a staggered manner when relevant nonclinical and/or clinical data become available. * Substudy-01 enrollment closed, actual enrollment is 13. * Substudy-02 enrollment closed, actual enrollment is 28. * Substudy-03 enrollment closed, actual enrollment is 8.

Conditions

• HIV-1-infection

Interventions

Type	Name	Description
DRUG	Bavtavirine	Administered orally
DRUG	B/F/TAF	Administered orally
DRUG	Standard of Care (Substudy 01)	Antiretroviral therapy, administered orally Non-NNRTIs, examples: ABC/DTG/3TC; DTG plus (TAF or TDF) plus (FTC or 3TC)
DRUG	GS-1720	Administered orally
DRUG	Standard of Care (Substudy 02)	Antiretroviral therapy, administered orally Example INSTIs: DTG/ABC/3TC or DTG/3TC
DRUG	GS-6212	Administered orally
DRUG	Standard of Care (Substudy 03)	Antiretroviral therapy, administered orally

Timeline

• Start date: 2022-10-26
• Primary completion: 2024-02-17
• Completion: 2024-03-18
• First posted: 2022-10-18
• Last updated: 2025-05-08
• Results posted: 2025-05-08

Locations

42 sites across 3 countries: United States, Dominican Republic, Thailand

Regulatory

• FDA-regulated drug study