A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age16-30
SponsorMerck Sharp & Dohme LLC
About this trial
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
Eligibility criteria
Qualifiers
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 ≥35 kg
Disqualifiers
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
Trial design
Treatments tested in this trial
- MK-8527
- Emtricitabine/tenofovir disoproxil (FTC/TDF)
- Placebo matched to MK-8527
- Placebo matched to FTC/TDF
Treatment groups
4,580 Participants
are divided into 2 treatment groupsLocations
30Kenya
UW - KNH; Rachuonyo County Hospital ( Site 0006)40222, Homabay CountyHoma Bay County, Kenya
Partners in Health and Research Development (PHRD) ( Site 0002)00202, ThikaKiambu County, Kenya
KEMRI-CMR-RCTP ( Site 0003)00200, NairobiKisumu County, Kenya
Kargeno Research & Policy Hub ( Site 0007)40123, Kisumu Kenya
Sponsors and collaborators
Merck Sharp & Dohme LLC
Lead sponsor
Source ClinicalTrials.gov