A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010)

A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy and Safety of MK-8527 Oral Once-Monthly as HIV-1 Preexposure Prophylaxis in Women

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

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