Study of Novel Antiretrovirals in Participants With HIV-1

Phase 1 Completed 49 enrolled Gilead Sciences

Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start: 2022-10-26
Primary completion: 2024-02-17
Completion: 2024-03-18

Outcome

Met primary endpoint

registry Substudy 01: Cohort 1: Bavtavirine 675 mg (High-Fat Meal) vs Placebo; p <0.0001; NCT05585307 ↗

Publications

Background Carl J. Fichtenbaum, Mezgebe Berhe, Jose Bordon, et al, Antiviral Activity, Safety, and Pharmacokinetics of GS-1720: A Novel Weekly Oral INSTI. Conference on Retroviruses and Opportunistic Infections, 2024, 3-6 March.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bavtavirine	Small molecule	675 mg	Oral
Subject	Bavtavirine	Small molecule	900 mg	Oral
Subject	Bavtavirine	Small molecule	1200 mg	Oral
Subject	GS-1720	Unknown	30 mg	Oral
Subject	GS-1720	Unknown	150 mg	Oral
Subject	GS-1720	Unknown	450 mg	Oral
Subject	GS-1720	Unknown	900 mg	Oral
Subject	GS-6212	Unknown	100 mg	Oral
Background	ABC	Unknown	—	Oral
Background	B/F/TAF	Unknown	—	Oral
Background	DTG	Unknown	—	Oral
Background	FTC	Unknown	—	Oral
Background	Lamivudine	Other / unclassified	—	Oral
Background	TAF	Unknown	—	Oral
Background	TDF	Unknown	—	Oral