Monthly pill could revolutionize HIV prevention

NCT ID NCT07044297

Recruiting now Prevention Sponsor: Merck Sharp & Dohme LLC Source: ClinicalTrials.gov ↗

First seen Nov 01, 2025 · Last updated Jun 23, 2026 · Updated 38 times

Summary

This phase 3 study tests MK-8527, a once-monthly oral pill, to see if it prevents HIV-1 infection as well as or better than the standard daily PrEP pill. About 4,390 HIV-negative adults at risk will be randomly assigned to receive either MK-8527 monthly or daily PrEP. Researchers will track new HIV infections and side effects over time.

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This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Contacts and locations

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Study contacts

Contact

Phone: •••-•••-•••• Email: •••••@•••••

Locations

Asian Hospital and Medical Center ( Site 0704)
RECRUITING

Muntinlupa, National Capital Region, 1780, Philippines

Contact Phone: •••-•••-••••
Asociación Civil Impacta Salud y Educación ( Site 0553)
ACTIVE_NOT_RECRUITING

Lima, 15063, Peru
Asociación Civil Selva Amazónica ( Site 0556)
ACTIVE_NOT_RECRUITING

Iquitos, Loreto, 16001, Peru
Bridge HIV - San Francisco Department of Public Health ( Site 0001)
RECRUITING

San Francisco, California, 94102, United States

Contact Phone: •••-•••-••••
CELAN,S.A ( Site 1052)
RECRUITING

Guatemala City, 01010, Guatemala

Contact Phone: •••-•••-••••
CEMDOE - Centro Médico de Diabetes, Obesidad y Especialidades ( Site 1001)
RECRUITING

Santo Domingo, Nacional, 10104, Dominican Republic

Contact Phone: •••-•••-••••
Central Texas Clinical Research ( Site 0014)
RECRUITING

Austin, Texas, 78705, United States

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Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada ( Site 0352)
RECRUITING

CABA, Buenos Aires, C1425AGC, Argentina

Contact Phone: •••-•••-••••
Centro de Estudios Infectológicos S.A. ( Site 0357)
RECRUITING

CABA, Buenos Aires, C1002ABN, Argentina

Contact Phone: •••-•••-••••
Centro de Referência e Treinamento DST/AIDS ( Site 0400)
RECRUITING

São Paulo, São Paulo, 04121-000, Brazil

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Checkpoint Zurich ( Site 1100)
RECRUITING

Zurich, 8005, Switzerland

Contact Phone: •••-•••-••••
Chulalongkorn Hospital ( Site 0807)
RECRUITING

Bangkok, Bangkok, 10330, Thailand

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Clinica de la Costa S.A.S. ( Site 0501)
RECRUITING

Barranquilla, Atlántico, 080020, Colombia

Contact Phone: •••-•••-••••
Clínica Médica Especializada en Pediatría e Infectología Pediátrica - Dr. Mario Melgar ( Site 1051)
RECRUITING

Guatemala City, 01009, Guatemala

Contact Phone: •••-•••-••••
Desmond Tutu Health Foundation ( Site 0250)
RECRUITING

Cape Town, Western Cape, 7925, South Africa

Contact Phone: •••-•••-••••
Endocardio ( Site 1003)
RECRUITING

Santo Domingo, Nacional, 10147, Dominican Republic

Contact Phone: •••-•••-••••
Faculty of Medicine Siriraj Hospital ( Site 0806)
ACTIVE_NOT_RECRUITING

Bangkok, Bangkok, 10700, Thailand
Foundation For Professional Development ( Site 0257)
RECRUITING

King Williams Town, Eastern Cape, 5660, South Africa

Contact Phone: •••-•••-••••
Fred Hutchinson Cancer Center - The Seattle HIV Vaccine Trials Unit ( Site 0002)
RECRUITING

Seattle, Washington, 98104, United States

Contact Phone: •••-•••-••••
Fundación Huésped ( Site 0350)
RECRUITING

CABA, Buenos Aires, C1427CEA, Argentina

Contact Phone: •••-•••-••••
Fundación IDEAA ( Site 0351)
RECRUITING

Buenos Aires, C1405CKC, Argentina

Contact Phone: •••-•••-••••
Fundación Valle del Lili ( Site 0502)
RECRUITING

Cali, Valle del Cauca Department, 760032, Colombia

Contact Phone: •••-•••-••••
Fundaçao de Medicina Tropical Doutor Heitor Vieira Dourado ( Site 0412)
RECRUITING

Manaus, Amazonas, 69040-000, Brazil

Contact Phone: •••-•••-••••
HIV Netherlands Australia Thailand Research Collaboration ( Site 0808)
RECRUITING

Bangkok, Bangkok, 10330, Thailand

Contact Phone: •••-•••-••••
Hanoi Medical University Hospital ( Site 0851)
ACTIVE_NOT_RECRUITING

Hanoi, Hanoi, 100000, Vietnam
Hope Clinic of the Emory Vaccine Center ( Site 0009)
RECRUITING

Decatur, Georgia, 30030, United States

Contact Phone: •••-•••-••••
Hopital Bichat - Claude Bernard ( Site 0101)
ACTIVE_NOT_RECRUITING

Paris, Île-de-France Region, 75018, France
Hopital Saint Louis ( Site 0100)
ACTIVE_NOT_RECRUITING

Paris, 75010, France
Hospital Dr. Hernán Henríquez Aravena ( Site 0451)
RECRUITING

Temuco, Araucania, 4781151, Chile

Contact Phone: •••-•••-••••
Hospital Geral de Nova Iguacu ( Site 0411)
RECRUITING

Nova Iguaçu, Rio de Janeiro, 26030-380, Brazil

Contact Phone: •••-•••-••••
Hospital Universitario San Ignacio ( Site 0503)
ACTIVE_NOT_RECRUITING

Bogotá, Bogota D.C., 110231, Colombia
Hospital das Clinicas FMUSP ( Site 0401)
RECRUITING

São Paulo, São Paulo, 05403-000, Brazil

Contact Phone: •••-•••-••••
Hôpital Tenon ( Site 0102)
ACTIVE_NOT_RECRUITING

Paris, 75970, France
IPS SURA San Diego ( Site 0500)
RECRUITING

Medellín, Antioquia, 50016, Colombia

Contact Phone: •••-•••-••••
Impact Research and Development Organisation (IRDO) ( Site 0202)
RECRUITING

Kisumu, 40141, Kenya

Contact Phone: •••-•••-••••
Inselspital Bern ( Site 1103)
RECRUITING

Bern, Canton of Bern, 3010, Switzerland

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Institute of HIV Research and Innovation ( Site 0810)
RECRUITING

Bangkok, Bangkok, 10330, Thailand

Contact Phone: •••-•••-••••
Instituto Dermatológico y Cirugía de Piel "Dr. Huberto Bogaert Díaz" ( Site 1002)
RECRUITING

Santo Domingo de Guzman, Santo Domingo Province, 10306, Dominican Republic

Contact Phone: •••-•••-••••
Instituto Nacional de Infectologia Evandro Chagas ( Site 0407)
RECRUITING

Rio de Janeiro, 21040-360, Brazil

Contact Phone: •••-•••-••••
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0353)
RECRUITING

Mar del Plata, Buenos Aires, B7600FZO, Argentina

Contact Phone: •••-•••-••••
Investigaciones Medicas en Salud ( Site 0552)
RECRUITING

Lima, 15046, Peru

Contact Phone: •••-•••-••••
Kargeno Research & Policy Hub ( Site 0200)
RECRUITING

Kisumu, 40123, Kenya

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LoveYourself Inc. ( Site 0705)
RECRUITING

Mandaluyong, National Capital Region, 1552, Philippines

Contact Phone: •••-•••-••••
MEDI-K ( Site 1053)
RECRUITING

Guatemala City, 01009, Guatemala

Contact Phone: •••-•••-••••
Meharry Medical College ( Site 0013)
RECRUITING

Nashville, Tennessee, 37208, United States

Contact Phone: •••-•••-••••
Montefiore Medical Center ( Site 0017)
RECRUITING

The Bronx, New York, 10467, United States

Contact Phone: •••-•••-••••
NC TraCS Institute - CTRC; University of North Carolina at Chapel Hill ( Site 0008)
RECRUITING

Chapel Hill, North Carolina, 27514-7064, United States

Contact Phone: •••-•••-••••
Obras Sociais Irma Dulce ( Site 0406)
RECRUITING

Salvador, Estado de Bahia, 41680-430, Brazil

Contact Phone: •••-•••-••••
Open Arms Healthcare Center ( Site 0025)
RECRUITING

Jackson, Mississippi, 39202, United States

Contact Phone: •••-•••-••••
Orlando Immunology Center ( Site 0021)
RECRUITING

Orlando, Florida, 32803, United States

Contact Phone: •••-•••-••••
Partners for Health and Development in Africa ( Site 0201)
RECRUITING

Nairobi, Nairobi City, 00506, Kenya

Contact Phone: •••-•••-••••
Perinatal HIV Research Unit (PHRU) ( Site 0253)
RECRUITING

Soweto, Gauteng, 1864, South Africa

Contact Phone: •••-•••-••••
Philadelphia Fight Community Health Centers ( Site 0011)
RECRUITING

Philadelphia, Pennsylvania, 19107, United States

Contact Phone: •••-•••-••••
Philippine General Hospital ( Site 0700)
RECRUITING

Manila, National Capital Region, 1000, Philippines

Contact Phone: •••-•••-••••
Policlínico Socios en Salud ( Site 0557)
ACTIVE_NOT_RECRUITING

Lima, 15024, Peru
Prisma Health Richland Hospital-Clinical Research Unit ( Site 0007)
RECRUITING

Columbia, South Carolina, 29203, United States

Contact Phone: •••-•••-••••
Regional Center for Infectious Diseases ( Site 0018)
RECRUITING

Greensboro, North Carolina, 27401, United States

Contact Phone: •••-•••-••••
Research Institute for Health Sciences ( Site 0809)
RECRUITING

Muang, Chiang Mai, 50200, Thailand

Contact Phone: •••-•••-••••
Ricardo Diaz Scientific Solutions ( Site 0402)
RECRUITING

São Paulo, São Paulo, 04030-030, Brazil

Contact Phone: •••-•••-••••
Rutgers New Jersey Medical School ( Site 0010)
RECRUITING

Newark, New Jersey, 07103, United States

Contact Phone: •••-•••-••••
Saint Hope Foundation, Inc. ( Site 0015)
RECRUITING

Bellaire, Texas, 77401, United States

Contact Phone: •••-•••-••••
School of Medicine Federal University of Minas Gerais ( Site 0417)
RECRUITING

Belo Horizonte, Minas Gerais, 30130-100, Brazil

Contact Phone: •••-•••-••••
Setshaba Research Centre ( Site 0252)
RECRUITING

Pretoria, Gauteng, 0152, South Africa

Contact Phone: •••-•••-••••
St. Jude Children's Research Hospital ( Site 0026)
RECRUITING

Memphis, Tennessee, 38105, United States

Contact Phone: •••-•••-••••
Thu Duc General Hospital ( Site 0881)
ACTIVE_NOT_RECRUITING

Ho Chi Minh City, 700000, Vietnam
UCLA Center for Clinical AIDS Research and Education ( Site 0004)
RECRUITING

Los Angeles, California, 90035, United States

Contact Phone: •••-•••-••••
USA Health University Hospitals ( Site 0020)
RECRUITING

Mobile, Alabama, 36617, United States

Contact Phone: •••-•••-••••
Universidad Nacional Mayor De San Marcos ( Site 0555)
RECRUITING

Lima, 15081, Peru

Contact Phone: •••-•••-••••
Universidad San Sebastian - Providencia ( Site 0454)
RECRUITING

Santiago, Region M. de Santiago, 7500000, Chile

Contact Phone: •••-•••-••••
Universidad de Chile - Hospital Clínico Universidad de Chile-Inmunologia Alergia y VIH ( Site 0450)
RECRUITING

Santiago, Region M. de Santiago, 8380420, Chile

Contact Phone: •••-•••-••••
Universiti Malaya Medical Centre ( Site 0651)
RECRUITING

Kuala Lumpur, 50603, Malaysia

Contact Phone: •••-•••-••••
University Hospital Basel ( Site 1102)
RECRUITING

Basel, Canton of Basel-City, 4031, Switzerland

Contact Phone: •••-•••-••••
University Medical Center New Orleans ( Site 0024)
RECRUITING

New Orleans, Louisiana, 70112, United States

Contact Phone: •••-•••-••••
University of Alabama at Birmingham-UAB 1917 Research Clinic ( Site 0006)
RECRUITING

Birmingham, Alabama, 35222, United States

Contact Phone: •••-•••-••••
University of Illinois Chicago ( Site 0027)
RECRUITING

Chicago, Illinois, 60612, United States

Contact Phone: •••-•••-••••
University of Miami RAPID Research ( Site 0003)
RECRUITING

Miami, Florida, 33136, United States

Contact Phone: •••-•••-••••
University of Pittsburgh Medical Center-Division of Infectious Diseases ( Site 0022)
RECRUITING

Pittsburgh, Pennsylvania, 15213, United States

Contact Phone: •••-•••-••••
Via Libre ( Site 0551)
ACTIVE_NOT_RECRUITING

Lima, 15001, Peru
Whitman-Walker Institute ( Site 0016)
RECRUITING

Washington D.C., District of Columbia, 20032, United States

Contact Phone: •••-•••-••••
Wits Maternal Adolescent and Child Health Research Unit (WMRU) ( Site 0256)
RECRUITING

Durban, KwaZulu-Natal, 4001, South Africa

Contact Phone: •••-•••-••••
Wits RHI Research Center ( Site 0251)
RECRUITING

Johannesburg, Gauteng, 2001, South Africa

Contact Phone: •••-•••-••••

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance

MK-8527 (oral tablet)

What this could lead to

If successful, this could offer a convenient once-monthly pill for HIV prevention, potentially improving adherence and reducing infection rates.

What could go wrong

This is a phase 3 trial, but results may show MK-8527 is less effective than daily PrEP or has unexpected side effects. The study is still recruiting, so outcomes are uncertain.

Conditions

The condition(s) this trial relates to.

AIDS

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV PRE-EXPOSURE PROPHYLAXIS HUMAN IMMUNODEFICIENCY VIRUS (HIV)