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MK-8527 for HIV-1 Prevention

This study is looking for new ways to prevent HIV-1 (Human Immunodeficiency Virus Type 1) infection. Researchers want to see if taking MK-8527 once a month works as well as, or better than, a standard daily medication called FTC/TDF for preventing HIV-1. They also want to understand the safety of MK-8527 and how well people tolerate it. You may be able to join if you are HIV-negative, are 16 years or older, and have had condomless receptive anal sex in the past 12 months. The study will measure how many people get HIV-1 infection and how many experience side effects over about two years. The current status of this study is unclear.

Study design
This is an interventional study planning to enroll 4390 participants. It compares MK-8527 to FTC/TDF and placebos.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to approximately 2 years to monitor for HIV-1 infection and adverse events.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07044297

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

Recruiting
PHASE3Ages 16+InterventionalTreatment
Merck Sharp & Dohme LLC
~4,390 participants
Updated 2026-08-14 on ClinicalTrials.gov
What's tested:MK-8527FTC/TDFPlacebo to MK-8527Placebo to FTC/TDF

At a glance

Recruiting sites
41 of 81 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants With Adjudicated Human Immunodeficiency Virus Type 1 (HIV-1) Infection
Measured over Up to approximately 2 years
+2 more outcomes measured

Conditions

Human Immunodeficiency Virus (HIV)
HIV Pre-Exposure Prophylaxis

Explore related trials

HIV Infection

Where it's being run

81 sites across 52 states
Peru5
Buenos Aires4
Bangkok4
São Paulo3
Guatemala3
National Capital Region3
Gauteng3
Alabama2

Study leadership

  • Medical Director · STUDY_DIRECTOR · Merck Sharp & Dohme LLC

Who to contact

Toll Free Number
[email protected]
1-888-577-8839
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Number of Participants With Adjudicated Human Immunodeficiency Virus Type 1 (HIV-1) InfectionUp to approximately 2 years

    The number of participants with adjudicated HIV-1 infection will be determined.

  • Number of Participants Who Experience At Least One Adverse Event (AE)Up to approximately 2 years

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants that experienced AEs will be reported.

  • Number of Participants Who Discontinue Study Intervention Due to an AEUp to approximately 2 years

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants that discontinued study intervention due to an AE will be reported.