A Study of Islatravir (MK-8591) in Anti-Retroviral Therapy-Naive, Human Immunodeficiency Virus-1 Infected Participants (MK-8591-003)

Phase 1 Completed 30 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupOpen-labelTreatment

Summary

This study will evaluate the safety, tolerability, pharmacokinetics, and anti-retroviral therapy (ART) activity of islatravir (MK-8591) monotherapy in ART-naive, human immunodeficiency virus-1 (HIV-1) infected participants. The primary hypothesis is that at a safe and tolerable dose of islatravir, the true mean difference in the plasma HIV-1 ribonucleic acid (RNA) reduction from baseline between islatravir and placebo is at least 0.5 log (base10) copies/mL.

Timeline

Start: 2015-09-17
Primary completion: 2017-05-11
Completion: 2017-05-11

Publications

Schurmann D, Rudd DJ, Zhang S, De Lepeleire I, Robberechts M, Friedman E, Keicher C, Huser A, Hofmann J, Grobler JA, Stoch SA, Iwamoto M, Matthews RP. Safety, pharmacokinetics, and antiretroviral activity of islatravir (ISL, MK-8591), a novel nucleoside reverse transcriptase translocation inhibitor, following single-dose administration to treatment-naive adults infected with HIV-1: an open-label, phase 1b, consecutive-panel trial. Lancet HIV. 2020 Mar;7(3):e164-e172. doi: 10.1016/S2352-3018(19)30372-8. Epub 2020 Jan 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Islatravir	Other / unclassified	0.25 mg	Oral
Subject	Islatravir	Other / unclassified	0.5 mg	Oral
Subject	Islatravir	Other / unclassified	1 mg	Oral
Subject	Islatravir	Other / unclassified	2 mg	Oral
Subject	Islatravir	Other / unclassified	10 mg	Oral
Subject	Islatravir	Other / unclassified	30 mg	Oral

Indications

No indication recorded.