Status:
RECRUITING
A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Human Immunodeficiency Virus (HIV)
HIV Pre-Exposure Prophylaxis
Eligibility:
FEMALE
16-30 years
Phase:
PHASE3
Brief Summary
Researchers are looking for new medicines to prevent HIV-1 (Human Immunodeficiency Virus Type 1) infection. The goals of this study are to learn: * If taking MK-8527 once a month works to prevent HI...
Eligibility Criteria
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
- Is confirmed Human Immunodeficiency Virus (HIV)-uninfected based on negative HIV-1/HIV-2 test results
- Has been sexually active (2 vaginal intercourse encounters with cisgender male individual(s) within the last 3 months)
- Was assigned female sex at birth and is cisgender.
- Weighs ≥35 kg
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
- Has hypersensitivity or other contraindication to any component of the study interventions
- Has evidence of acute or chronic hepatitis B infection
- Has a history of malignancy within 5 years of screening except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer
- Has taken cabotegravir, lenacapavir, or any other long-acting HIV prevention product at any time
- Is receiving or is anticipated to require any prohibited therapies from 30 days prior to Day 1 through the study duration
- Has received an HIV vaccine at any time (ie, through past participation in an investigational clinical study) or monoclonal antibodies to HIV within 12 months before Day 1
Key Trial Info
Start Date :
November 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 18 2027
Estimated Enrollment :
4580 Patients enrolled
Trial Details
Trial ID
NCT07071623
Start Date
November 10 2025
End Date
October 18 2027
Last Update
March 30 2026
Active Locations (29)
Enter a location and click search to find clinical trials sorted by distance.
1
UW - KNH; Rachuonyo County Hospital ( Site 0006)
Homabay County, Homa Bay County, Kenya, 40222
2
Partners in Health and Research Development (PHRD) ( Site 0002)
Thika, Kiambu County, Kenya, 00202
3
KEMRI-CMR-RCTP ( Site 0003)
Nairobi, Kisumu County, Kenya, 00200
4
Kargeno Research & Policy Hub ( Site 0007)
Kisumu, Kenya, 40123