Ulonivirine
Sponsors
Merck Sharp & Dohme LLC
Conditions
HIVHIV-1 InfectionHealthyHepatic Insufficiency
Phase 1
Evaluation of Safety, Tolerability, Pharmacokinetics, and Antiretroviral Activity of Ulonivirine (MK-8507) in Human Immunodeficiency Virus (HIV-1)-Infected Participants (MK-8507-003)
CompletedNCT02174159
Start: 2014-09-15End: 2015-07-23Updated: 2023-04-10
Ulonivirine (MK-8507) in Participants With Mild or Moderate Hepatic Impairment (MK-8507-014)
Not yet recruitingNCT05093972
Start: 2026-04-07End: 2026-09-10Target: 22Updated: 2025-02-18
A Clinical Trial to Evaluate the Effect of Ulonivirine (MK-8507) on Heart Rhythm in Healthy Adults (MK-8507-012)
Active, not recruitingNCT07305831
Start: 2026-01-22End: 2026-04-09Target: 62Updated: 2026-03-03
Phase 2
Dose Ranging, Switch Study of Islatravir (MK-8591) and Ulonivirine (MK-8507) Once-Weekly in Virologically-Suppressed Adults With Human Immunodeficiency Virus Type 1 (HIV-1) [MK-8591-013]
CompletedNCT04564547
Start: 2021-03-09End: 2025-01-30Updated: 2026-01-26
A Phase 2b, Randomized, Active-Controlled, Double-Blind, Dose-Ranging Clinical Study to Evaluate a Switch to Islatravir (ISL) and MK-8507 Once-Weekly in Adults with HIV-1 Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) Once-Daily
CompletedCTIS2024-511041-19-00
Start: 2021-04-06End: 2025-01-28Target: 48Updated: 2025-01-29
A Phase 2/3, Randomized, Active-Controlled, Open-Label (Phase 2) and Double-Blind (Phase 3) Study to Evaluate the Antiretroviral Activity, Safety, and Tolerability of Islatravir (ISL) and Ulonivirine (ULO) Once Weekly Compared With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) Once Daily in Treatment-Naïve Adult Participants Living With HIV 1
Not yet recruitingCTIS2025-522519-40-00
Target: 35Updated: 2026-02-16