Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Monthly HIV prevention pill could replace daily dose

NCT ID NCT07044297

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 18, 2026 · Updated 16 times

Summary

This large phase 3 trial is testing whether a new oral pill called MK-8527, taken just once a month, can prevent HIV infection as well as the standard daily PrEP pill. About 4,390 people at risk of HIV will be randomly assigned to receive either the monthly pill or daily Truvada (plus placebos to maintain blinding). The study will track new HIV infections and side effects over time.

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 taken once a month)
What this could lead to
If successful, this could offer a convenient once-monthly pill for HIV prevention, potentially improving adherence and reducing daily pill burden.
What could go wrong
This is a phase 3 trial, but results are not yet known. The monthly pill may not be as effective as daily PrEP, and side effects or tolerability issues could arise.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

4,390 people

The number who actually took part.

Started

Jul 2025

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

16 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Is confirmed HIV-uninfected based on negative HIV-1/HIV-2 test results * Is a cisgender man, transgender woman (assigned male sex at birth), transgender man (assigned female sex at birth), or gender nonbinary person * Has had condomless receptive anal sex in the 12 months prior to screening (not including sex occurring in a mutually monogamous relationship) and has at least 1 of the following: receptive anal sex with 2 or more partners in the 3 months prior to screening (regardless of condom use), rectal or urethral gonorrhea or chlamydia or incident syphilis in the 6 months prior to screening, or any self-reported stimulant drug use with sex in the 3 months prior to screening * 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 anal or cervical cancers * 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 * Is expecting to donate eggs at any time during the study

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for HIV pre-exposure prophylaxis are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

AIDS HIV infectious disease prevention target

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)

Contacts and locations

Locations

  • Asian Hospital and Medical Center ( Site 0704)

    Muntinlupa, National Capital Region, 1780, Philippines

  • Asociación Civil Impacta Salud y Educación ( Site 0553)

    Lima, 15063, Peru

  • Asociación Civil Selva Amazónica ( Site 0556)

    Iquitos, Loreto, 16001, Peru

  • Bridge HIV - San Francisco Department of Public Health ( Site 0001)

    San Francisco, California, 94102, United States

  • CELAN,S.A ( Site 1052)

    Guatemala City, 01010, Guatemala

  • CEMDOE - Centro Médico de Diabetes, Obesidad y Especialidades ( Site 1001)

    Santo Domingo, Nacional, 10104, Dominican Republic

  • Central Texas Clinical Research ( Site 0014)

    Austin, Texas, 78705, United States

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

    CABA, Buenos Aires, C1425AGC, Argentina

  • Centro de Estudios Infectológicos S.A. ( Site 0357)

    CABA, Buenos Aires, C1002ABN, Argentina

  • Centro de Referência e Treinamento DST/AIDS ( Site 0400)

    São Paulo, São Paulo, 04121-000, Brazil

  • Checkpoint Zurich ( Site 1100)

    Zurich, 8005, Switzerland

  • Chulalongkorn Hospital ( Site 0807)

    Bangkok, Bangkok, 10330, Thailand

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

    Barranquilla, Atlántico, 080020, Colombia

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

    Guatemala City, 01009, Guatemala

  • Desmond Tutu Health Foundation ( Site 0250)

    Cape Town, Western Cape, 7925, South Africa

  • Endocardio ( Site 1003)

    Santo Domingo, Nacional, 10147, Dominican Republic

  • Faculty of Medicine Siriraj Hospital ( Site 0806)

    Bangkok, Bangkok, 10700, Thailand

  • Foundation For Professional Development ( Site 0257)

    King Williams Town, Eastern Cape, 5660, South Africa

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

    Seattle, Washington, 98104, United States

  • Fundación Huésped ( Site 0350)

    CABA, Buenos Aires, C1427CEA, Argentina

  • Fundación IDEAA ( Site 0351)

    Buenos Aires, C1405CKC, Argentina

  • Fundación Valle del Lili ( Site 0502)

    Cali, Valle del Cauca Department, 760032, Colombia

  • Fundaçao de Medicina Tropical Doutor Heitor Vieira Dourado ( Site 0412)

    Manaus, Amazonas, 69040-000, Brazil

  • HIV Netherlands Australia Thailand Research Collaboration ( Site 0808)

    Bangkok, Bangkok, 10330, Thailand

  • Hanoi Medical University Hospital ( Site 0851)

    Hanoi, Hanoi, 100000, Vietnam

  • Hope Clinic of the Emory Vaccine Center ( Site 0009)

    Decatur, Georgia, 30030, United States

  • Hopital Bichat - Claude Bernard ( Site 0101)

    Paris, Île-de-France Region, 75018, France

  • Hopital Saint Louis ( Site 0100)

    Paris, 75010, France

  • Hospital Dr. Hernán Henríquez Aravena ( Site 0451)

    Temuco, Araucania, 4781151, Chile

  • Hospital Geral de Nova Iguacu ( Site 0411)

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

  • Hospital Universitario San Ignacio ( Site 0503)

    Bogotá, Bogota D.C., 110231, Colombia

  • Hospital das Clinicas FMUSP ( Site 0401)

    São Paulo, São Paulo, 05403-000, Brazil

  • Hôpital Tenon ( Site 0102)

    Paris, 75970, France

  • IPS SURA San Diego ( Site 0500)

    Medellín, Antioquia, 50016, Colombia

  • Impact Research and Development Organisation (IRDO) ( Site 0202)

    Kisumu, 40141, Kenya

  • Inselspital Bern ( Site 1103)

    Bern, Canton of Bern, 3010, Switzerland

  • Institute of HIV Research and Innovation ( Site 0810)

    Bangkok, Bangkok, 10330, Thailand

  • Instituto Dermatológico y Cirugía de Piel "Dr. Huberto Bogaert Díaz" ( Site 1002)

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

  • Instituto Nacional de Infectologia Evandro Chagas ( Site 0407)

    Rio de Janeiro, 21040-360, Brazil

  • Instituto de Investigaciones Clínicas Mar del Plata ( Site 0353)

    Mar del Plata, Buenos Aires, B7600FZO, Argentina

  • Investigaciones Medicas en Salud ( Site 0552)

    Lima, 15046, Peru

  • LoveYourself Inc. ( Site 0705)

    Mandaluyong, National Capital Region, 1552, Philippines

  • MEDI-K ( Site 1053)

    Guatemala City, 01009, Guatemala

  • Meharry Medical College ( Site 0013)

    Nashville, Tennessee, 37208, United States

  • Montefiore Medical Center ( Site 0017)

    The Bronx, New York, 10467, United States

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

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

  • Nyanza Reproductive Health Society ( Site 0200)

    Kisumu, 40100, Kenya

  • Obras Sociais Irma Dulce ( Site 0406)

    Salvador, Estado de Bahia, 41680-430, Brazil

  • Open Arms Healthcare Center ( Site 0025)

    Jackson, Mississippi, 39202, United States

  • Orlando Immunology Center ( Site 0021)

    Orlando, Florida, 32803, United States

  • Partners for Health and Development in Africa ( Site 0201)

    Nairobi, Nairobi City, 00506, Kenya

  • Perinatal HIV Research Unit (PHRU) ( Site 0253)

    Soweto, Gauteng, 1864, South Africa

  • Philadelphia Fight Community Health Centers ( Site 0011)

    Philadelphia, Pennsylvania, 19107, United States

  • Philippine General Hospital ( Site 0700)

    Manila, National Capital Region, 1000, Philippines

  • Policlínico Socios en Salud ( Site 0557)

    Lima, 15024, Peru

  • Prisma Health Richland Hospital-Clinical Research Unit ( Site 0007)

    Columbia, South Carolina, 29203, United States

  • Regional Center for Infectious Diseases ( Site 0018)

    Greensboro, North Carolina, 27401, United States

  • Research Institute for Health Sciences ( Site 0809)

    Muang, Chiang Mai, 50200, Thailand

  • Ricardo Diaz Scientific Solutions ( Site 0402)

    São Paulo, São Paulo, 04030-030, Brazil

  • Rutgers New Jersey Medical School ( Site 0010)

    Newark, New Jersey, 07103, United States

  • Saint Hope Foundation, Inc. ( Site 0015)

    Bellaire, Texas, 77401, United States

  • School of Medicine Federal University of Minas Gerais ( Site 0417)

    Belo Horizonte, Minas Gerais, 30130-100, Brazil

  • Setshaba Research Centre ( Site 0252)

    Pretoria, Gauteng, 0152, South Africa

  • St. Jude Children's Research Hospital ( Site 0026)

    Memphis, Tennessee, 38105, United States

  • Thu Duc General Hospital ( Site 0881)

    Ho Chi Minh City, 700000, Vietnam

  • UCLA Center for Clinical AIDS Research and Education ( Site 0004)

    Los Angeles, California, 90035, United States

  • USA Health University Hospitals ( Site 0020)

    Mobile, Alabama, 36617, United States

  • Universidad Nacional Mayor De San Marcos ( Site 0555)

    Lima, 15081, Peru

  • Universidad San Sebastian - Providencia ( Site 0454)

    Santiago, Region M. de Santiago, 7500000, Chile

  • Universidad de Chile - Hospital Clínico Universidad de Chile-Inmunologia Alergia y VIH ( Site 0450)

    Santiago, Region M. de Santiago, 8380420, Chile

  • Universiti Malaya Medical Centre ( Site 0651)

    Kuala Lumpur, 50603, Malaysia

  • University Hospital Basel ( Site 1102)

    Basel, Canton of Basel-City, 4031, Switzerland

  • University Medical Center New Orleans ( Site 0024)

    New Orleans, Louisiana, 70112, United States

  • University of Alabama at Birmingham-UAB 1917 Research Clinic ( Site 0006)

    Birmingham, Alabama, 35222, United States

  • University of Illinois Chicago ( Site 0027)

    Chicago, Illinois, 60612, United States

  • University of Miami RAPID Research ( Site 0003)

    Miami, Florida, 33136, United States

  • University of Pittsburgh Medical Center-Division of Infectious Diseases ( Site 0022)

    Pittsburgh, Pennsylvania, 15213, United States

  • Via Libre ( Site 0551)

    Lima, 15001, Peru

  • Whitman-Walker Institute ( Site 0016)

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

  • Wits Maternal Adolescent and Child Health Research Unit (WMRU) ( Site 0256)

    Durban, KwaZulu-Natal, 4001, South Africa

  • Wits RHI Research Center ( Site 0251)

    Johannesburg, Gauteng, 2001, South Africa

More trials for these conditions

Other studies related to the condition(s) this trial covers.