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Recruiting Phase 3 NCT07044297

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

Phase 3 – large-scale trial before approval
Conditions: Human Immunodeficiency Virus (HIV) HIV Pre-Exposure Prophylaxis

Sponsor: Merck Sharp & Dohme LLC

trial.available_in: БГ
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
Who can participate
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
Locations 15
Argentina (1)
Centro de Estudios Infectológicos S.A. ( Site 0357)
CABA , Buenos Aires
Study Coordinator
Brazil (1)
Fundaçao de Medicina Tropical Doutor Heitor Vieira Dourado ( Site 0412)
Manaus , Amazonas
Study Coordinator
Chile (1)
Hospital Dr. Hernán Henríquez Aravena ( Site 0451)
Temuco , Araucania
Study Coordinator
Colombia (1)
IPS SURA San Diego ( Site 0500)
Medellín , Antioquia
Study Coordinator
Dominican Republic (1)
CEMDOE - Centro Médico de Diabetes, Obesidad y Especialidades ( Site 1001)
Santo Domingo , Nacional
Study Coordinator
France (1)
Hopital Saint Louis ( Site 0100)
Paris
Study Coordinator
Guatemala (1)
Clínica Médica Especializada en Pediatría e Infectología Pediátrica - Dr. Mario Melgar ( Site 1051)
Guatemala City
Study Coordinator
Malaysia (1)
Universiti Malaya Medical Centre ( Site 0651)
Kuala Lumpur
Study Coordinator
Peru (1)
Asociación Civil Selva Amazónica ( Site 0556)
Iquitos , Loreto
Study Coordinator
Philippines (1)
LoveYourself Inc. ( Site 0705)
Mandaluyong , National Capital Region
Study Coordinator
South Africa (1)
Foundation For Professional Development ( Site 0257)
King Williams Town , Eastern Cape
Study Coordinator
Switzerland (1)
University Hospital Basel ( Site 1102)
Basel , Canton of Basel-City
Study Coordinator
Thailand (1)
Chulalongkorn Hospital ( Site 0807)
Bangkok , Bangkok
Study Coordinator
United States (1)
University of Alabama at Birmingham-UAB 1917 Research Clinic ( Site 0006)
Birmingham , Alabama
Study Coordinator
Vietnam (1)
Hanoi Medical University Hospital ( Site 0851)
Hanoi , Hanoi
Study Coordinator
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
16 Years
Healthy volunteers
No
Start date
31.07.2025
Completion date
22.07.2027
Registry ID
NCT07044297
Source
anzctr
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