drugset
drugset / Trial / NCT05585307

Study of Novel Antiretrovirals in Participants With HIV-1

NCT05585307 ↗

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

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

EvaluationDrugModalityDoseRoute
Subject Bavtavirine Small molecule 675 mg Oral
Subject Bavtavirine Small molecule 900 mg Oral
Subject Bavtavirine Small molecule 1200 mg Oral
Subject GS-6212 Unknown 100 mg Oral
Subject Lepetegravir Unknown 30 mg Oral
Subject Lepetegravir Unknown 150 mg Oral
Subject Lepetegravir Unknown 450 mg Oral
Subject Lepetegravir Unknown 900 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

Indications

HIV infectious disease