At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 352 enrolled
Drug / intervention
MK-8527 +1 moredrug
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.
A Phase 2a, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral MK-8527 Once Monthly in Participants at Low-Risk for HIV-1 Infection
In Brief
A Phase 2 clinical trial evaluating MK-8527 and Placebo to MK-8527 for HIV and HIV Pre-exposure Prophylaxis. Completed, enrolled 352 participants across 18 sites in 3 countries.
Detailed Summary
This double-blind, placebo-controlled study was designed to assess the safety, tolerability, and pharmacokinetics of oral MK-8527 taken once monthly (QM) in participants at low risk for human immunodeficiency virus Type 1 (HIV-1) infection.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV, HIV Pre-exposure Prophylaxis
CountriesIsrael, South Africa, United States
Collaborators--
Timeline
Phase 2CompletedFinished
202420252026
First PostedSep 2023
Enrollment StartNov 2023
Primary CompletionDec 2024
Study CompletionFeb 2025
TodayJul 2026
First PostedSep 21, 2023
Enrollment StartNov 8, 2023
Primary CompletionDec 12, 2024
Study CompletionFeb 12, 2025
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 2.8 years ago
Interventions
MK-8527drug
MK-8527 capsule
Placebo to MK-8527drug
Placebo capsule matched to MK-8527