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

Age: 16 Years and older

Gender: All

Start Date: 07/31/2025

Primary Completion Date (Estimated): 07/22/2027

Study Completion Date (Estimated): 07/22/2027

Accepts Healthy Volunteers: No

Trial Purpose and Description

Eligibility Criteria

Age: 16 Years and older

Gender: All

Accepts Healthy Volunteers: No

Inclusion criteria:

The main inclusion criteria include but are not limited to the following:

* Is confirmed HIV-uninfected based on negative HIV-1/HIV-2 test results

* Is a cisgender man, transgender woman (assigned male sex at birth), transgender man (assigned female sex at birth), or gender nonbinary person

* Has had condomless receptive anal sex in the 12 months prior to screening (not including sex occurring in a mutually monogamous relationship) and has at least 1 of the following: receptive anal sex with 2 or more partners in the 3 months prior to screening (regardless of condom use), rectal or urethral gonorrhea or chlamydia or incident syphilis in the 6 months prior to screening, or any self-reported stimulant drug use with sex in the 3 months prior to screening

* 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 anal or cervical cancers

* 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

* Is expecting to donate eggs at any time during the study