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

NCT02217904 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-08-12

Study results available
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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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02217904 on ClinicalTrials.gov