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Human Immunodeficiency Virus (HIV)Phase 3NCT07044297

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

A Phase 3 study testing MK-8527 and FTC/TDF in people with Human Immunodeficiency Virus (HIV) and HIV Pre-Exposure Prophylaxis, run by Merck Sharp & Dohme LLC at 81 sites in 16 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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 as well as or better than a standard (usual) pre-exposure prophylaxis (PrEP) taken once a day About the… Read more about this study

Who is it for?
Ages 16 years and olderHealthy volunteers can take part
What is being tested?
MK-8527 and FTC/TDF
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
4,390 participants
Where
81 sitesin 16 countries
Study dates
31 Jul 2025to 22 Jul 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

81 sites in 16 countries.

81 sites in 16 countries

United States23 sites

  • Central Texas Clinical Research ( Site 0014)

    Austin, Texas, 78705

  • Saint Hope Foundation, Inc. ( Site 0015)

    Bellaire, Texas, 77401

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

    Birmingham, Alabama, 35222

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

    Chapel Hill, North Carolina, 27514-7064

  • University of Illinois Chicago ( Site 0027)

    Chicago, Illinois, 60612

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

    Columbia, South Carolina, 29203

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

    Decatur, Georgia, 30030

  • Regional Center for Infectious Diseases ( Site 0018)

    Greensboro, North Carolina, 27401

  • Open Arms Healthcare Center ( Site 0025)

    Jackson, Mississippi, 39202

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

    Los Angeles, California, 90035

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

    Memphis, Tennessee, 38105

  • University of Miami RAPID Research ( Site 0003)

    Miami, Florida, 33136

  • USA Health University Hospitals ( Site 0020)

    Mobile, Alabama, 36617

  • Meharry Medical College ( Site 0013)

    Nashville, Tennessee, 37208

  • University Medical Center New Orleans ( Site 0024)

    New Orleans, Louisiana, 70112

  • Rutgers New Jersey Medical School ( Site 0010)

    Newark, New Jersey, 07103

  • Orlando Immunology Center ( Site 0021)

    Orlando, Florida, 32803

  • Philadelphia Fight Community Health Centers ( Site 0011)

    Philadelphia, Pennsylvania, 19107

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

    Pittsburgh, Pennsylvania, 15213

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

    San Francisco, California, 94102

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

    Seattle, Washington, 98104

  • Montefiore Medical Center ( Site 0017)

    The Bronx, New York, 10467

  • Whitman-Walker Institute ( Site 0016)

    Washington D.C., District of Columbia, 20032

Other trials in United States

Brazil8 sites

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

    Belo Horizonte, Minas Gerais, 30130-100

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

    Manaus, Amazonas, 69040-000

  • Hospital Geral de Nova Iguacu ( Site 0411)

    Nova Iguaçu, Rio de Janeiro, 26030-380

  • Instituto Nacional de Infectologia Evandro Chagas ( Site 0407)

    Rio de Janeiro, 21040-360

  • Obras Sociais Irma Dulce ( Site 0406)

    Salvador, Estado de Bahia, 41680-430

  • Ricardo Diaz Scientific Solutions ( Site 0402)

    São Paulo, São Paulo, 04030-030

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

    São Paulo, São Paulo, 04121-000

  • Hospital das Clinicas FMUSP ( Site 0401)

    São Paulo, São Paulo, 05403-000

Other trials in Brazil

Peru6 sites

  • Asociación Civil Selva Amazónica ( Site 0556)

    Iquitos, Loreto, 16001

  • Via Libre ( Site 0551)

    Lima, 15001

  • Policlínico Socios en Salud ( Site 0557)

    Lima, 15024

  • Investigaciones Medicas en Salud ( Site 0552)

    Lima, 15046

  • Asociación Civil Impacta Salud y Educación ( Site 0553)

    Lima, 15063

  • Universidad Nacional Mayor De San Marcos ( Site 0555)

    Lima, 15081

Other trials in Peru

South Africa6 sites

  • Desmond Tutu Health Foundation ( Site 0250)

    Cape Town, Western Cape, 7925

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

    Durban, KwaZulu-Natal, 4001

  • Wits RHI Research Center ( Site 0251)

    Johannesburg, Gauteng, 2001

  • Foundation For Professional Development ( Site 0257)

    King Williams Town, Eastern Cape, 5660

  • Setshaba Research Centre ( Site 0252)

    Pretoria, Gauteng, 0152

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

    Soweto, Gauteng, 1864

Other trials in South Africa

Argentina5 sites

  • Fundación IDEAA ( Site 0351)

    Buenos Aires, C1405CKC

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

    CABA, Buenos Aires, C1002ABN

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

    CABA, Buenos Aires, C1425AGC

  • Fundación Huésped ( Site 0350)

    CABA, Buenos Aires, C1427CEA

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

    Mar del Plata, Buenos Aires, B7600FZO

Other trials in Argentina

Thailand5 sites

  • Chulalongkorn Hospital ( Site 0807)

    Bangkok, Bangkok, 10330

  • HIV Netherlands Australia Thailand Research Collaboration ( Site 0808)

    Bangkok, Bangkok, 10330

  • Institute of HIV Research and Innovation ( Site 0810)

    Bangkok, Bangkok, 10330

  • Faculty of Medicine Siriraj Hospital ( Site 0806)

    Bangkok, Bangkok, 10700

  • Research Institute for Health Sciences ( Site 0809)

    Muang, Chiang Mai, 50200

Other trials in Thailand

Colombia4 sites

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

    Barranquilla, Atlántico, 080020

  • Hospital Universitario San Ignacio ( Site 0503)

    Bogotá, Bogota D.C., 110231

  • Fundación Valle del Lili ( Site 0502)

    Cali, Valle del Cauca Department, 760032

  • IPS SURA San Diego ( Site 0500)

    Medellín, Antioquia, 50016

Other trials in Colombia

Chile3 sites

  • Universidad San Sebastian - Providencia ( Site 0454)

    Santiago, Region M. de Santiago, 7500000

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

    Santiago, Region M. de Santiago, 8380420

  • Hospital Dr. Hernán Henríquez Aravena ( Site 0451)

    Temuco, Araucania, 4781151

Other trials in Chile

Dominican Republic3 sites

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

    Santo Domingo, Nacional, 10104

  • Endocardio ( Site 1003)

    Santo Domingo, Nacional, 10147

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

    Santo Domingo de Guzman, Santo Domingo Province, 10306

Other trials in Dominican Republic

France3 sites

  • Hopital Saint Louis ( Site 0100)

    Paris, 75010

  • Hôpital Tenon ( Site 0102)

    Paris, 75970

  • Hopital Bichat - Claude Bernard ( Site 0101)

    Paris, Île-de-France Region, 75018

Other trials in France

Guatemala3 sites

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

    Guatemala City, 01009

  • MEDI-K ( Site 1053)

    Guatemala City, 01009

  • CELAN,S.A ( Site 1052)

    Guatemala City, 01010

Other trials in Guatemala

Kenya3 sites

  • Nyanza Reproductive Health Society ( Site 0200)

    Kisumu, 40100

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

    Kisumu, 40141

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

    Nairobi, Nairobi City, 00506

Other trials in Kenya

Philippines3 sites

  • LoveYourself Inc. ( Site 0705)

    Mandaluyong, National Capital Region, 1552

  • Philippine General Hospital ( Site 0700)

    Manila, National Capital Region, 1000

  • Asian Hospital and Medical Center ( Site 0704)

    Muntinlupa, National Capital Region, 1780

Other trials in Philippines

Switzerland3 sites

  • University Hospital Basel ( Site 1102)

    Basel, Canton of Basel-City, 4031

  • Inselspital Bern ( Site 1103)

    Bern, Canton of Bern, 3010

  • Checkpoint Zurich ( Site 1100)

    Zurich, 8005

Other trials in Switzerland

Vietnam2 sites

  • Hanoi Medical University Hospital ( Site 0851)

    Hanoi, Hanoi, 100000

  • Thu Duc General Hospital ( Site 0881)

    Ho Chi Minh City, 700000

Other trials in Vietnam

Malaysia1 site

  • Universiti Malaya Medical Centre ( Site 0651)

    Kuala Lumpur, 50603

Other trials in Malaysia

About this study

Official 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

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 as well as or better than a standard (usual) pre-exposure prophylaxis (PrEP) taken once a day
  • About the safety of MK-8527 and if people tolerate it
Being tested
MK-8527, FTC/TDF, Placebo to MK-8527, Placebo to FTC/TDF
Medical subject headings
Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MK-8527Drug

    Oral tablet

  • FTC/TDFDrug

    Also called Truvada, Emtricitabine/Tenofovir Disoproxil Fumarate

    Oral tablet

  • Placebo to MK-8527Drug

    Placebo tablet matched to MK-8527

  • Placebo to FTC/TDFDrug

    Placebo tablet matched to FTC/TDF

Study groups in NCT07044297
Study groupRoleWhat they receive
MK-8527ExperimentalParticipants will receive 11 mg MK-8527 once monthly (QM) and placebo to FTC/TDF once daily (QD) for up to approximately 2 years. Participants will then receive open-label 200 mg FTC/245 mg TDF QD for an additional 28 days.
Receives: Drug: MK-8527; Drug: FTC/TDF; Drug: Placebo to FTC/TDF
FTC/TDFActive comparatorParticipants will receive 200 mg FTC/245 mg TDF QD and placebo to MK-8527 QM for up to approximately 2 years. Participants will then receive open-label 200 mg FTC/245 mg TDF QD for an additional 28 days.
Receives: Drug: FTC/TDF; Drug: Placebo to MK-8527

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: Up to approximately 2 years

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

    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 reported.

    Measured: Up to approximately 2 years

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

    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 reported.

    Measured: Up to approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2025
  2. Study start31 Jul 2025
  3. Primary completion22 Jul 2027 (estimated)
  4. Study completion22 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
4,390 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07044297
Sponsor's protocol ID
8527-011
Other IDs
MK-8527-011, 2025-520610-58-00, U1111-1317-6239, 2025
Status last verified
Sep 2026
First submitted
26 Jun 2025
Last updated
18 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MK-8527 and FTC/TDF in people with Human Immunodeficiency Virus (HIV) and HIV Pre-Exposure Prophylaxis, run by Merck Sharp & Dohme LLC at 81 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 81 sites in United States, Brazil, Peru, South Africa, Argentina and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adjudicated Human Immunodeficiency Virus Type 1 (HIV-1) Infection (time frame: Up to approximately 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07044297.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.

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