CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 30 enrolled
Drug / intervention
1 mg islatravir +5 moredrug
Likely dose
1 mg islatravirfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02217904
NCT02217904Phase 1Completed
CompareCT.gov

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

Merck Sharp & Dohme LLC·interventional·Posted Aug 15, 2014·Updated Aug 12, 2019

In Brief

A Phase 1 clinical trial evaluating 1 mg islatravir, 2 mg islatravir, and 4 other interventions for HIV-1. Completed, enrolled 30 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV-1
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 15, 2014
Enrollment StartSep 17, 2015
Primary CompletionMay 11, 2017
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 11.9 years ago

Interventions

1 mg islatravirdrug

Single oral dose of 1 mg islatravir administered following ≥8 hour fast

2 mg islatravirdrug

Single oral dose of 2 mg islatravir administered following ≥8 hour fast

10 mg islatravirdrug

Single oral dose of 10 mg islatravir administered following ≥8 hour fast

30 mg islatravirdrug

Single oral dose of 30 mg islatravir administered following ≥8 hour fast

0.5 mg islatravirdrug

Single oral dose of 0.5 mg islatravir administered following ≥8 hour fast

0.25 mg islatravirdrug

Single oral dose of 0.25 mg islatravir administered following ≥8 hour fast