Last updated 5 days ago
A Clinical Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-011)
4390 patients around the world
Available in Guatemala, Argentina, United States
Merck Sharp & Dohme LLC
4Research sites
4390Patients around the world
This study is for people with
Hiv
Hiv prophylaxis
Requirements for the patient
From 16 Years
All Gender
Medical requirements
- 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 and has at least 1 of the following: receptive anal sex with 2 or more partners in the 3 months prior to screening, 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.
- 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 or monoclonal antibodies to HIV within 12 months before Day 1.Is expecting to donate eggs at any time during the study.
Sites
Centro Médico Maffei - CABA, Buenos Aires
Recruiting
Fundacion IDEAA
Recruiting
Medi-K Cayala
Recruiting
Centro de Investigaciones Clinicas de Latinoamerica S.A. - CELAN
Recruiting
SponsorMerck Sharp & Dohme LLC
Study typeInterventional
Conditions
Hiv prophylaxis
Requirements
From 16 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07044297
