A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010)
Recruiting
Phase 3
Interventional Study
Human Immunodeficiency Virus (HIV)
HIV Pre-Exposure Prophylaxis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 16 – 30
- Sex
- Female
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 4,580 (estimated)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
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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
Trial Locations
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Eligibility Criteria
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) withi…
Contacts