RecruitingPhase 3NCT07071623

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

Sponsor

Merck Sharp & Dohme LLC

Enrollment

4,580 participants

Start Date

Nov 10, 2025

Study Type

INTERVENTIONAL

Conditions

Human Immunodeficiency Virus (HIV)HIV Pre-Exposure Prophylaxis

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

Sex: FEMALEMin Age: 16 YearsMax Age: 30 Years

Plain Language Summary

Simplified for easier understanding

This trial tests MK-8527, a long-acting injectable HIV prevention drug (PrEP), to see if it can protect cisgender women from getting HIV. **You may be eligible if...** - You were assigned female at birth and identify as a cisgender woman - You are confirmed HIV-negative - You have been sexually active (at least 2 vaginal sex encounters with a cisgender male in the past 3 months) - You weigh at least 35 kg **You may NOT be eligible if...** - You have an allergy or contraindication to any study drug ingredients - You have an active or chronic hepatitis B infection - You have a history of cancer within the past 5 years - You have previously used cabotegravir, lenacapavir, or any other long-acting HIV prevention product - You have received an HIV vaccine in the past Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGMK-8527

Oral tablet

DRUGEmtricitabine/tenofovir disoproxil (FTC/TDF)

Oral tablet

DRUGPlacebo matched to MK-8527

Placebo oral tablet matched to MK-8527

DRUGPlacebo matched to FTC/TDF

Placebo oral tablet matched to FTC/TDF

Locations(29)

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

Setshaba Research Centre ( Site 0032)

Pretoria, Gauteng, South Africa

SA Medical Research Council - Chatsworth Clinical Research Site ( Site 0026)

Chatsworth, KwaZulu-Natal, South Africa

SA Medical Research Council - Botha's Hill Clinical Research Site ( Site 0035)

Durban, KwaZulu-Natal, South Africa

CAPRISA eThekwini Clinical Research Site ( Site 0030)

Durban, KwaZulu-Natal, South Africa

Wits Maternal Adolescent and Child Health Research Unit (WMRU) ( Site 0027)

Durban, KwaZulu-Natal, South Africa

Umlazi Clinical Research Site ( Site 0047)

Durban, KwaZulu-Natal, South Africa

SYNAPSE Research Clinic ( Site 0043)

Edendale, KwaZulu-Natal, South Africa

Qhakaza Mbokodo Research Clinic ( Site 0028)

Ladysmith, KwaZulu-Natal, South Africa

SA Medical Research Council - Phoenix Clinical Research Site ( Site 0037)

Phoenix, KwaZulu-Natal, South Africa

CAPRISA Vulindlela Clinical Research Site ( Site 0029)

Pietermaritzburg, KwaZulu-Natal, South Africa

Africa Health Research Institute (AHRI) - Mtubatuba ( Site 0049)

Somkhele - Mtubatuba, KwaZulu-Natal, South Africa

SA Medical Research Council - Verulam Clinical Research Site ( Site 0036)

Verulam, KwaZulu-Natal, South Africa

Desmond Tutu Health Foundation. Philippi Village ( Site 0024)

Cape Town, Western Cape, South Africa

DTHF Masiphumelele Clinical Research Site ( Site 0023)

Cape Town, Western Cape, South Africa

Vuka Research Clinic ( Site 0025)

Khayelitsha, Western Cape, South Africa

Infectious Diseases Institute Kalangala ( Site 0063)

Kalangala District, Kalangala, Uganda

MU-JHU Research Collaboration - Mityana ( Site 0061)

Mityana, District, Mityana, Uganda

UVRI Clinical Research Program Initiative Ltd (UVRI CRP) ( Site 0067)

Entebbe, Wakiso, Uganda

MU-JHU Research Collaboration - Kampala ( Site 0062)

Kampala, Uganda

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07071623

Related Trials

Using Multiphase Optimization Strategy (MOST) to Optimize a Cost-effective, Sustainable and Scalable Smoking Cessation Package for Smokers in HIV Clinical Care

NCT065983971 location

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

NCT0704429778 locations

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

Conditions

Summary

Eligibility

Plain Language Summary

Interventions

Locations(29)

Related Trials

Using Multiphase Optimization Strategy (MOST) to Optimize a Cost-effective, Sustainable and Scalable Smoking Cessation Package for Smokers in HIV Clinical Care

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

Persuasive Health Communication Intervention for HIV/HCV

The Trans-Led Care Study

Voluntary HIV Screening in the General Population in France