Monthly MK-8527 to prevent HIV-1 infection

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• UW - KNH; Rachuonyo County Hospital ( Site 0006)
  Homabay County, Homa Bay County, Kenya Recruiting
• KEMRI-CMR-RCTP ( Site 0003)
  Nairobi, Kisumu County, Kenya Recruiting
• Kargeno Research & Policy Hub ( Site 0007)
  Kisumu, Kenya Recruiting
• Synergy Biomed Research Institute ( Site 0040)
  East London, Eastern Cape, South Africa Recruiting
• Wits RHI Ward 21 Clinical Research site ( Site 0022)
  Johannesburg, Gauteng, South Africa Recruiting
• Perinatal HIV Research Unit (PHRU) ( Site 0033)
  Johnnesburg, Gauteng, South Africa Recruiting

Study contacts

• Study coordinator: Toll Free Number
• Email: Trialsites@msd.com
• Phone: 1-888-577-8839

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.