Overview
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 HIV-1 infection better than a standard (usual) pre-exposure prophylaxis (PrEP) taken once a day
- About the safety of MK-8527 and if people tolerate it
Eligibility
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