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A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010)

RecruitingPhase 3Ages 16 Years - 30 YearsFemaleMerck Sharp & Dohme LLC
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In plain words

What the trial is, and whether it could suit you

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 better than a standard (usual) pre-exposure prophylaxis (PrEP) taken once a day * About the safety of MK-8527 and if people tolerate it

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Is confirmed Human Immunodeficiency Virus (HIV)-uninfected based on negative HIV-1/HIV-2 test results * Has been sexually active (2 vaginal intercourse encounters with cisgender male individual(s) within the last 3 months) * Was assigned female sex at birth and is cisgender. * Weighs โ‰ฅ35 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 cervical cancer * 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
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What it tests

  • MK-8527
  • Emtricitabine/tenofovir disoproxil (FTC/TDF)
  • Placebo matched to MK-8527
  • Placebo matched to FTC/TDF
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Where

30 sites
UW - KNH; Rachuonyo County Hospital ( Site 0006)
Homabay County, Kenya
Partners in Health and Research Development (PHRD) ( Site 0002)
Thika, Kenya
KEMRI-CMR-RCTP ( Site 0003)
Nairobi, Kenya
Kargeno Research & Policy Hub ( Site 0007)
Kisumu, Kenya
Synergy Biomed Research Institute ( Site 0040)
East London, South Africa
Foundation For Professional Development ( Site 0031)
Ndevana, South Africa
Josha Research ( Site 0045)
Bloemfontein, South Africa
Wits RHI Ward 21 Clinical Research site ( Site 0022)
Johannesburg, South Africa

โ€ฆand 22 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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