A Clinical Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-011)

About

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 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

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 3

Gender

All

Healthy Volunteers

Yes

Minimum Age

16 Years

Maximum Age

N/A

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

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