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NCT Number: NCT07071623

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

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

Recruiting

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Key information

Conditions

Human Immunodeficiency Virus (HIV) Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections HIV Pre-Exposure Prophylaxis Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

16 year–30 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

UW - KNH; Rachuonyo County Hospital ( Site 0006), Homabay County, Homa Bay County, Kenya

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MK-8527

Drug

Oral tablet

Emtricitabine/tenofovir disoproxil (FTC/TDF)

Drug

Oral tablet

Other names: Truvada, Emtricitabine/Tenofovir Disoproxil Fumarate

Placebo matched to MK-8527

Drug

Placebo oral tablet matched to MK-8527

Placebo matched to FTC/TDF

Drug

Placebo oral tablet matched to FTC/TDF

Primary outcomes

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

    Time frame: Up to ~2 years

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

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

    Time frame: Up to ~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 presented.

  3. Number of Participants who Discontinue Study Intervention Due to an AE

    Time frame: Up to ~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 presented.

Study contacts

Contact information is provided by the study sponsor or research team.

Toll Free Number

CONTACT

[email protected]

1-888-577-8839

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 17, 2025
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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