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

ReclutandoFase 3ClinicalTrials.gov

ID: NCT07044297Tipo: INTERVENTIONALInicio: 31 de jul de 2025Fin estimado: 22 de jul de 2027

Enfermedades Infecciosas Alergia e Inmunología

Traducción no disponible, mostrando original

Resumen

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

Elegibilidad

Edad mínima: 16 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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

Intervenciones

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

Ubicaciones

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

CABA, Buenos Aires, Argentina

Study Coordinator · +5402920323936

RECRUITING

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

CABA, Buenos Aires, Argentina

Study Coordinator · +5401148019001

RECRUITING

Fundación Huésped ( Site 0350)

CABA, Buenos Aires, Argentina

Study Coordinator · +541121209999

RECRUITING

Instituto de Investigaciones Clínicas Mar del Plata ( Site 0353)

Mar del Plata, Buenos Aires, Argentina

Study Coordinator · +5492234365218

RECRUITING

Fundación IDEAA ( Site 0351)

Buenos Aires, Argentina

Study Coordinator · +541149040623

RECRUITING

Patrocinadores

PrincipalMerck Sharp & Dohme LLC

Contactos

Toll Free Number

CONTACT

Trialsites@msd.com 1-888-577-8839

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

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