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

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

Overview

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

Interventions

• Drug MK-8527
  Oral tablet
• Drug FTC/TDF
  Oral tablet
• Drug Placebo to MK-8527
  Placebo tablet matched to MK-8527
• Drug Placebo to FTC/TDF
  Placebo tablet matched to FTC/TDF

Primary outcome measures

• Number of Participants With Adjudicated Human Immunodeficiency Virus Type 1 (HIV-1) Infection [Time frame: Up to approximately 2 years]
• Number of Participants Who Experience At Least One Adverse Event (AE) [Time frame: Up to approximately 2 years]
• Number of Participants Who Discontinue Study Intervention Due to an AE [Time frame: Up to approximately 2 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 23 centers

• University of Alabama at Birmingham-UAB 1917 Research Clinic ( Site 0006) — Birmingham
• USA Health University Hospitals ( Site 0020) — Mobile
• UCLA Center for Clinical AIDS Research and Education ( Site 0004) — Los Angeles
• Bridge HIV - San Francisco Department of Public Health ( Site 0001) — San Francisco
• Whitman-Walker Institute ( Site 0016) — Washington D.C.
• University of Miami RAPID Research ( Site 0003) — Miami
• Orlando Immunology Center ( Site 0021) — Orlando
• Hope Clinic of the Emory Vaccine Center ( Site 0009) — Decatur
• … and 15 more centers

Brazil · 8 centers

• Fundaçao de Medicina Tropical Doutor Heitor Vieira Dourado ( Site 0412) — Manaus
• Obras Sociais Irma Dulce ( Site 0406) — Salvador
• School of Medicine Federal University of Minas Gerais ( Site 0417) — Belo Horizonte
• Hospital Geral de Nova Iguacu ( Site 0411) — Nova Iguaçu
• Ricardo Diaz Scientific Solutions ( Site 0402) — São Paulo
• Centro de Referência e Treinamento DST/AIDS ( Site 0400) — São Paulo
• Hospital das Clinicas FMUSP ( Site 0401) — São Paulo
• Instituto Nacional de Infectologia Evandro Chagas ( Site 0407) — Rio de Janeiro

Peru · 6 centers

• Asociación Civil Selva Amazónica ( Site 0556) — Iquitos
• Via Libre ( Site 0551) — Lima
• Policlínico Socios en Salud ( Site 0557) — Lima
• Investigaciones Medicas en Salud ( Site 0552) — Lima
• Asociación Civil Impacta Salud y Educación ( Site 0553) — Lima
• Universidad Nacional Mayor De San Marcos ( Site 0555) — Lima

South Africa · 6 centers

• Foundation For Professional Development ( Site 0257) — King Williams Town
• Wits RHI Research Center ( Site 0251) — Johannesburg
• Setshaba Research Centre ( Site 0252) — Pretoria
• Perinatal HIV Research Unit (PHRU) ( Site 0253) — Soweto
• Wits Maternal Adolescent and Child Health Research Unit (WMRU) ( Site 0256) — Durban
• Desmond Tutu Health Foundation ( Site 0250) — Cape Town

Argentina · 5 centers

• Centro de Estudios Infectológicos S.A. ( Site 0357) — CABA
• Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada ( Site 0352) — CABA
• Fundación Huésped ( Site 0350) — CABA
• Instituto de Investigaciones Clínicas Mar del Plata ( Site 0353) — Mar del Plata
• Fundación IDEAA ( Site 0351) — Buenos Aires

Thailand · 5 centers

• Chulalongkorn Hospital ( Site 0807) — Bangkok
• HIV Netherlands Australia Thailand Research Collaboration ( Site 0808) — Bangkok
• Institute of HIV Research and Innovation ( Site 0810) — Bangkok
• Faculty of Medicine Siriraj Hospital ( Site 0806) — Bangkok
• Research Institute for Health Sciences ( Site 0809) — Muang

Colombia · 4 centers

• IPS SURA San Diego ( Site 0500) — Medellín
• Clinica de la Costa S.A.S. ( Site 0501) — Barranquilla
• Hospital Universitario San Ignacio ( Site 0503) — Bogotá
• Fundación Valle del Lili ( Site 0502) — Cali

Chile · 3 centers

• Hospital Dr. Hernán Henríquez Aravena ( Site 0451) — Temuco
• Universidad San Sebastian - Providencia ( Site 0454) — Santiago
• Universidad de Chile - Hospital Clínico Universidad de Chile-Inmunologia Alergia y VIH ( S — Santiago

Dominican Republic · 3 centers

• CEMDOE - Centro Médico de Diabetes, Obesidad y Especialidades ( Site 1001) — Santo Domingo
• Endocardio ( Site 1003) — Santo Domingo
• Instituto Dermatológico y Cirugía de Piel "Dr. Huberto Bogaert Díaz" ( Site 1002) — Santo Domingo de Guzman

France · 3 centers

• Hopital Saint Louis ( Site 0100) — Paris
• Hôpital Tenon ( Site 0102) — Paris
• Hopital Bichat - Claude Bernard ( Site 0101) — Paris

Guatemala · 3 centers

• Clínica Médica Especializada en Pediatría e Infectología Pediátrica - Dr. Mario Melgar ( S — Guatemala City
• MEDI-K ( Site 1053) — Guatemala City
• CELAN,S.A ( Site 1052) — Guatemala City

Kenya · 3 centers

• Partners for Health and Development in Africa ( Site 0201) — Nairobi
• Nyanza Reproductive Health Society ( Site 0200) — Kisumu
• Impact Research and Development Organisation (IRDO) ( Site 0202) — Kisumu

Philippines · 3 centers

• LoveYourself Inc. ( Site 0705) — Mandaluyong
• Philippine General Hospital ( Site 0700) — Manila
• Asian Hospital and Medical Center ( Site 0704) — Muntinlupa

Switzerland · 3 centers

• University Hospital Basel ( Site 1102) — Basel
• Inselspital Bern ( Site 1103) — Bern
• Checkpoint Zurich ( Site 1100) — Zurich

Vietnam · 2 centers

• Hanoi Medical University Hospital ( Site 0851) — Hanoi
• … and 1 more center

Malaysia · 1 center

• Universiti Malaya Medical Centre ( Site 0651) — Kuala Lumpur

Identifiers

NCT: NCT07044297 · 8527-011 · MK-8527-011 · 2025-520610-58-00 · U1111-1317-6239

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗