Status:
COMPLETED
Safety and Pharmacokinetic Study of Oral MK-8527 QM in Participants at Low-Risk for HIV-1 Infection (MK-8527-007)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
HIV
HIV Pre-exposure Prophylaxis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 immunode...
Eligibility Criteria
Inclusion
- Is confirmed HIV-uninfected based on negative HIV-1/HIV-2 test result before randomization
- Has low-risk of HIV infection
- Females: is not pregnant or breastfeeding and is either not a participant of childbearing potential (POCBP) OR is a POCBP and uses an acceptable contraception or is abstinent from penile-vaginal intercourse
Exclusion
- Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator
- Has an active diagnosis of hepatitis due to any cause, including active hepatitis B (HBV) infection (defined as HBsAg-positive) or hepatitis C virus (HCV) infection (defined as detectable HCV ribonucleic acid \[RNA\])
- Prior use of MK-8527 or islatravir (MK-8591)
Key Trial Info
Start Date :
November 8 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 12 2025
Estimated Enrollment :
352 Patients enrolled
Trial Details
Trial ID
NCT06045507
Start Date
November 8 2023
End Date
February 12 2025
Last Update
January 7 2026
Active Locations (18)
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1
Velocity Clinical Research, North Hollywood ( Site 0054)
North Hollywood, California, United States, 91606
2
Bridge HIV- San Francisco Department of Public Health ( Site 0042)
San Francisco, California, United States, 94102
3
Velocity Clinical Research, Hallandale Beach ( Site 0052)
Hallandale, Florida, United States, 33009
4
Community Medical Care Center ( Site 0056)
Immokalee, Florida, United States, 34142