MK-8527-004
Status:Planned
Phase:Open Label, I
Principal Investigator(s):
Objective: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.
Last updated September 20, 2022
Prevention Option(s):Treatment U=U
Study Design:Open label
Arms and Assigned Interventions
DescriptionExperimental: Panel A: MK-8527 1.0 mg
Participants receive a single oral dose of MK-8527 1.0 mg.
Mode of DeliveryTablet
ARMsExperimental
DescriptionExperimental: Panel B: MK-8527 ≤10.0 mg
Participants receive a single oral dose of MK-8527 ≤10.0 mg.
Mode of DeliveryTablet
ARMsExperimental
DescriptionExperimental: Panel C: MK-8527 ≤10.0 mg
Participants receive a single oral dose of MK-8527 ≤10.0 mg.
Mode of DeliveryTablet
ARMsExperimental
Official Code:
NCT05494736
Trial Sponsors:
Merck Sharp & Dohme LLC
Start Date
End Date
September 20, 2022
September 20, 2022
Enrollment:20
Age range:
18 Years ↔
60 Years
Population:Cisgender Men, Cisgender Women