What is MK-8527 studying for HIV prevention?

MK-8527 is being studied to see if taking it once a month can prevent HIV-1 infection as well as or better than the standard daily pre-exposure prophylaxis (PrEP). The study aims to understand how well MK-8527 works and how safe it is when used for HIV prevention. This research is sponsored by Merck Sharp & Dohme LLC.

Who may be eligible for this HIV prevention clinical trial?

People 16 years or older who are confirmed HIV-uninfected and identify as cisgender men, transgender women or men, or gender nonbinary may be eligible. They should have recent sexual behaviors that increase HIV risk and weigh at least 35 kg. Certain health conditions and prior use of specific HIV prevention drugs may exclude participation. Please review eligibility criteria for more details.

Is there any cost to participate in this HIV prevention clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or related costs.

Actively Recruiting

Phase 3

Age: 16Years +

All Genders

Healthy Volunteers

ID07044297

A Phase 3, Randomized, Active-Controlled, Double-Blind Study to Evaluate the Safety and Effectiveness of MK-8527 Taken Once Monthly as HIV-1 Pre-Exposure Prophylaxis

Led by Merck Sharp & Dohme LLC · Updated on 2026-06-08

4390

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating new medicines to prevent infection with Human Immunodeficiency Virus Type 1 HIV-1. This Phase 3 clinical trial aims to find out if taking MK-8527 once a month is as effective or better than a standard daily pre-exposure prophylaxis PrEP in preventing HIV-1 infection. The study also assesses the safety and tolerability of MK-8527. Participants are randomly assigned to one of two groups one group takes 11 mg of MK-8527 once monthly plus a placebo daily pill matching FTCTDF, and the other group takes 200 mg FTC245 mg TDF daily plus a placebo monthly pill matching MK-8527. This treatment phase lasts up to approximately two years. Afterward, all participants receive open-label FTCTDF daily for an additional 28 days. During the study, participants are closely monitored for HIV-1 infection, adverse events, and any discontinuation due to side effects over the two-year treatment period. The primary outcomes include the number of participants who acquire HIV-1 infection, experience any adverse events, or stop the study intervention because of adverse events. Follow-up and safety assessments continue through the entire treatment period to evaluate the medicines performance and participant well-being.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 16Years +

All Genders

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

Confirmed HIV-uninfected based on negative HIV-1/HIV-2 test results
Identify as cisgender man, transgender woman (assigned male at birth), transgender man (assigned female at birth), or gender nonbinary person
Had condomless receptive anal sex in the 12 months before screening outside a mutually monogamous relationship
Have at least one of the following: receptive anal sex with two or more partners in the 3 months before screening, recent rectal or urethral gonorrhea or chlamydia or incident syphilis in the 6 months before screening, or stimulant drug use with sex in the 3 months before screening
Weigh at least 35 kg

You will not qualify if you...

Hypersensitivity or contraindication to any study intervention component
Evidence of acute or chronic hepatitis B infection
History of malignancy within 5 years except adequately treated basal cell or squamous cell skin cancer, or in situ anal or cervical cancers
Prior use of cabotegravir, lenacapavir, or other long-acting HIV prevention products
Receiving or expected to require prohibited therapies from 30 days before Day 1 through study duration
Previous HIV vaccine or monoclonal antibody to HIV within 12 months before Day 1
Expecting to donate eggs during the study

Research Team

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