CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 12 enrolled
Drug / intervention
Islatravirdrug
Likely dose
Islatravir 60 mgfrom 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/NCT04303156
NCT04303156Phase 1Completed
CompareCT.gov

An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of Islatravir (MK-8591) in Subjects With Severe Renal Impairment

Merck Sharp & Dohme LLC·interventional·Posted Mar 10, 2020·Updated Oct 28, 2021

In Brief

A Phase 1 clinical trial evaluating Islatravir for Human Immunodeficiency Virus (HIV) Infection. Completed, enrolled 12 participants across 2 sites in 2 countries.

Detailed Summary

This study will evaluate the general tolerability and pharmacokinetics (PK) of a single 60 mg dose of MK-8591 (Islatravir) in participants with severe renal insufficiency, compared to participants in good health.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHuman Immunodeficiency Virus (HIV) Infection
CountriesGermany, United States
Collaborators--

Timeline

Phase 1CompletedFinished
202120222023202420252026
First PostedMar 10, 2020
Enrollment StartJun 18, 2020
Primary CompletionOct 19, 2020
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 6.3 years ago

Interventions

Islatravirdrug

Single oral dose of 60 mg Islatravir administered in capsule form