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NCT05494736

MK-8527 Single-Dose Trial in HIV-1 Infected Participants (MK-8527-004)

A Single-Dose Clinical Trial to Study the Safety, Tolerability, Pharmacokinetics, and Anti-Retroviral Activity of MK-8527 Monotherapy in Anti-Retroviral Therapy (ART)-Naïve, HIV-1 Infected Participants
Merck Sharp & Dohme LLC·Phase 1·ClinicalTrials.gov·drugNot yet recruiting
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Study focus
Disease/Condition
Human Immunodeficiency Virus
Drug/Device/Intervention
MK-8527
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Merck Sharp & Dohme LLC
Timeline & enrollment
Phase
Phase 1
Start date
Sep 23, 2022
End date
Feb 13, 2023
Enrollment
20 participants
Primary outcome

Change from baseline in plasma HIV-1 ribonucleic acid (RNA),Number of participants experiencing ≥1 adverse event (AE),Number of participants discontinuing from study due to an AE

Summary

This is a single-dose clinical study to evaluate the safety, tolerability, pharmacokinetics,
 and anti-retroviral activity of MK-8527 in antiretroviral therapy (ART)-naïve participants
 with human immunodeficiency virus type 1 (HIV-1) infection. The primary hypothesis is that,
 at a dose that is safe and generally well tolerated, MK-8527 will have antiretroviral
 activity as measured by a reduction from baseline in plasma HIV-1 ribonucleic acid (RNA) of
 ≥1.0 log10 copies/mL.

ICD-10 classifications
Human immunodeficiency virus [HIV] diseaseUnspecified human immunodeficiency virus [HIV] diseaseHuman immunodeficiency virus [HIV] disease resulting in other conditionsHuman immunodeficiency virus [HIV] disease resulting in infectious and parasitic diseasesAsymptomatic human immunodeficiency virus [HIV] infection status
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05494736
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05494736 through Pure Global AI's free database. This Phase 1 trial is sponsored by Merck Sharp & Dohme LLC and is currently Not yet recruiting. The study focuses on Human Immunodeficiency Virus. Target enrollment is 20 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.