A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010)
Launched by MERCK SHARP & DOHME LLC · Jul 8, 2025
Trial Information
Current as of July 22, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new medicine called MK-8527 to see if taking it once a month can better prevent HIV infection compared to the usual daily HIV prevention pill (called PrEP). The researchers also want to find out if MK-8527 is safe and if people can comfortably take it without serious side effects. This study is specifically for people who were assigned female at birth, are not infected with HIV, and have been sexually active with cisgender men recently.
To join the study, participants need to be HIV-negative, weigh at least 35 kilograms (about 77 pounds), and have had at least two vaginal sex encounters with cisgender men in the past three months. Certain conditions, like having hepatitis B, recent cancer, or prior use of other long-acting HIV prevention medicines, mean a person cannot join. The study is not recruiting yet, but if eligible, participants can expect to take the study medicine once a month and have regular check-ups to monitor their health and how well the medicine works. This trial aims to find easier and effective ways to protect people from HIV with fewer daily pills.
Gender
FEMALE
Eligibility criteria
- 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
About Merck Sharp & Dohme Llc
Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., is a leading global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines and vaccines that address unmet medical needs. With a strong focus on research and development, Merck Sharp & Dohme leverages advanced science and technology to enhance patient outcomes across various therapeutic areas, including oncology, infectious diseases, and cardiovascular health. Committed to ethical practices and regulatory compliance, the company actively engages in clinical trials to advance medical knowledge and improve health care for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Trial Officials
Medical Director
Study Director
Merck Sharp & Dohme LLC
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported