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

Launched by MERCK SHARP & DOHME LLC · Jun 26, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medicine called MK-8527 to see if taking it once a month can prevent HIV infection as well as or better than the current daily prevention pill (known as PrEP). The researchers also want to learn if MK-8527 is safe and if people can tolerate taking it without serious side effects.

People who might be eligible to join this study are those who do not have HIV and are at higher risk of getting it. This includes cisgender men, transgender women and men, and nonbinary individuals who have had condomless receptive anal sex recently, especially if they have had multiple partners, certain sexually transmitted infections, or have used stimulant drugs during sex. Participants must weigh at least 35 kilograms (about 77 pounds). During the study, participants will be closely monitored to check how well MK-8527 works and to make sure it is safe. This trial is not yet open for enrollment, but it aims to offer a new option for HIV prevention that could be more convenient than taking a pill every day.

Gender

ALL

Eligibility criteria

• 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