CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 5 enrolled
Drug / intervention
MK-8583drug
Likely dose
Not stated in 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/NCT03552536
NCT03552536Phase 1Completed
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A Single-Dose Clinical Trial to Study the Safety, Tolerability, Pharmacokinetics, and Anti- Retroviral Activity of MK-8583 Monotherapy in Anti-Retroviral Therapy (ART)-Naïve, HIV-1 Infected Patients

Merck Sharp & Dohme LLC·interventional·Posted Jun 12, 2018·Updated Mar 4, 2020

In Brief

A Phase 1 clinical trial evaluating MK-8583 for HIV-1 Infection. Completed, enrolled 5 participants across 1 site.

Detailed Summary

This study aims to evaluate the safety, tolerability, pharmacokinetics (PK), and anti-retroviral therapy (ART) activity of the tenofovir prodrug, MK-8583 monotherapy in ART-naïve, HIV-1 infected participants. The primary hypothesis is that at a dose that is sufficiently safe and generally well tolerated, MK-8583 has superior anti-retroviral activity compared to historical placebo, as measured by change from baseline in plasma HIV-1 ribonucleic acid (RNA) (log10 copies/mL) at 168 hours post-dose.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV-1 Infection
CountriesGermany
Collaborators--

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedJun 12, 2018
Enrollment StartOct 7, 2018
Primary CompletionMar 11, 2019
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 8.1 years ago

Interventions

MK-8583drug

A single oral dose of MK-8583 in capsule form