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A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010) | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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

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

NCT07071623•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

16 - 30 years

Sex

FEMALE

Healthy Volunteers

Yes

Inclusion Criteria

•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

•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

Locations (28)

UW - KNH; Rachuonyo County Hospital ( Site 0006)

Homabay County, Homa Bay County, Kenya

Partners in Health and Research Development (PHRD) ( Site 0002)

Thika, Kiambu County, Kenya

KEMRI-CMR-RCTP ( Site 0003)

Nairobi, Kisumu County, Kenya

Kargeno Research & Policy Hub ( Site 0007)

Kisumu, Kenya

Synergy Biomed Research Institute ( Site 0040)

East London, Eastern Cape, South Africa

Foundation For Professional Development ( Site 0031)

Ndevana, Eastern Cape, South Africa

Josha Research ( Site 0045)

Bloemfontein, Free State, South Africa

Wits RHI Ward 21 Clinical Research site ( Site 0022)

Johannesburg, Gauteng, South Africa

Helen Joseph Hospital-Clinical HIV Research Unit ( Site 0048)

Johannesburg, Gauteng, South Africa

Perinatal HIV Research Unit (PHRU) ( Site 0033)

Johnnesburg, Gauteng, South Africa

Key Dates

Start Date

November 10, 2025

Primary Completion Date

October 18, 2027

Completion Date

October 18, 2027

Last Updated

March 20, 2026

Enrollment

4,580

ESTIMATED participants

Conditions

Human Immunodeficiency Virus (HIV)HIV Pre-Exposure Prophylaxis

Interventions

MK-8527

DRUG

Emtricitabine/tenofovir disoproxil (FTC/TDF)

DRUG

Placebo matched to MK-8527

DRUG

Placebo matched to FTC/TDF

DRUG

Contacts

Toll Free Number

CONTACT

1-888-577-8839 Trialsites@msd.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 20, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Doravirine (DOR) in Human Immunodeficiency Virus (HIV)-Infected Children Aged 4 Weeks to <12 Years and <45 kg (MK-1439-066)

Secondary Cervical Cancer Prevention of Vulnerable Women With HPV and HIV Co-infection in India

Strategies to AchieVe Viral Suppression for Youth With HIV

Project neuroARTEMIS

Persuasive Health Communication Intervention for HIV/HCV

Client-Centered Care Coordination for Black Men Who Have Sex With Men