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Monthly MK-8527 to prevent HIV-1 infection

A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy and Safety of MK-8527 Oral Once-Monthly as HIV-1 Preexposure Prophylaxis in Women

Phase 3 Interventional Merck Sharp & Dohme LLC · NCT07071623

This study will test whether taking MK-8527 once a month prevents HIV-1 better than daily oral PrEP in HIV-negative, sexually active cisgender women.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment4580 (estimated)
Ages16 Years to 30 Years
SexFemale
SponsorMerck Sharp & Dohme LLC Industry-sponsored
Locations30 sites (Homabay County, Homa Bay County and 29 other locations)
Trial IDNCT07071623 on ClinicalTrials.gov

What this trial studies

In this Phase 3, randomized trial participants who are HIV-negative cisgender women will receive either monthly MK-8527 or daily emtricitabine/tenofovir disoproxil (FTC/TDF) with matching placebos. The study will compare rates of HIV-1 infection between the groups and closely monitor safety and tolerability. Major inclusion criteria include being assigned female at birth, cisgender, sexually active, HIV-uninfected, and weighing at least 35 kg; key exclusions include hepatitis B infection, recent malignancy, or prior use of long-acting HIV prevention products. The trial is sponsored by Merck and is being conducted at multiple sites in Kenya.

Who should consider this trial

Good fit: Ideal candidates are HIV-negative, sexually active cisgender women who were assigned female at birth and can attend study visits at participating Kenyan sites.

Not a fit: People with active hepatitis B, a recent history of malignancy, prior use of long-acting HIV prevention products, or those who are not cisgender women assigned female at birth are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, a once-monthly MK-8527 option could make HIV prevention easier to use and help reduce new infections among at-risk women.

How similar studies have performed: Other long-acting prevention approaches—most notably injectable cabotegravir—have shown higher protection than daily oral PrEP in prior trials, so the monthly long-acting approach has promising precedent.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Homabay County, Homa Bay County and 29 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Human Immunodeficiency VirusHIV Pre-Exposure Prophylaxis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.