RecruitingPhase 3

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

Kenya, South Africa, Uganda4,580 participantsStarted 2025-11-10

Plain-language 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 better than a standard (usual) pre-exposure prophylaxis (PrEP) taken once a day * About the safety of MK-8527 and if people tolerate it

Who can participate

Age range

16 Years – 30 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants with Adjudicated Human Immunodeficiency Virus Type 1 (HIV-1) Infection

Timeframe: Up to ~2 years

Number of Participants who Experience At Least One Adverse Event (AE)

Timeframe: Up to ~2 years

Number of Participants who Discontinue Study Intervention Due to an AE

Timeframe: Up to ~2 years

Trial details

NCT IDNCT07071623

SponsorMerck Sharp & Dohme LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-10-18

Contact for this trial

Toll Free Number

1-888-577-8839 Trialsites@msd.com

View on ClinicalTrials.gov More Human Immunodeficiency Virus (HIV) trials

Plain-language summary

Who can participate

Age range

16 Years – 30 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Participants with Adjudicated Human Immunodeficiency Virus Type 1 (HIV-1) Infection

Timeframe: Up to ~2 years

Number of Participants who Experience At Least One Adverse Event (AE)

Timeframe: Up to ~2 years

Number of Participants who Discontinue Study Intervention Due to an AE

Timeframe: Up to ~2 years