MK-8527 Single-Dose Trial in HIV-1 Infected Participants (MK-8527-004) - Trial NCT05494736
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.
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Study Focus
Sponsor & Location
Merck Sharp & Dohme LLC
Timeline & Enrollment
Phase 1
Sep 23, 2022
Feb 13, 2023
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
Data Source
ClinicalTrials.gov
NCT05494736
Non-Device Trial