NCT02217904

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

A Single-Dose Clinical Trial to Study the Safety, Tolerability, Pharmacokinetics, and Anti-Retroviral Activity of MK-8591 Monotherapy in Anti-Retroviral Therapy (ART)-Naive, HIV-1 Infected Patients

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV-1

Interventions

Type	Name	Description
DRUG	1 mg islatravir	Single oral dose of 1 mg islatravir administered following ≥8 hour fast
DRUG	2 mg islatravir	Single oral dose of 2 mg islatravir administered following ≥8 hour fast
DRUG	10 mg islatravir	Single oral dose of 10 mg islatravir administered following ≥8 hour fast
DRUG	30 mg islatravir	Single oral dose of 30 mg islatravir administered following ≥8 hour fast
DRUG	0.5 mg islatravir	Single oral dose of 0.5 mg islatravir administered following ≥8 hour fast
DRUG	0.25 mg islatravir	Single oral dose of 0.25 mg islatravir administered following ≥8 hour fast

Timeline

• Start date: 2015-09-17
• Primary completion: 2017-05-11
• Completion: 2017-05-11
• First posted: 2014-08-15
• Last updated: 2019-08-12
• Results posted: 2018-12-03