A Double-Blind, Placebo-Controlled and Active-controlled Trial to Evaluate the Effect of a Supratherapeutic Dose of MK-8527 on the QTc Interval in Healthy Adult Participants
Abstract
Researchers are looking for new medicines to prevent Human Immunodeficiency Virus Type 1 (HIV-1) infection. HIV-1 is the most common type of HIV, which is a virus that attacks cells of the immune system. Medicines to prevent HIV-1 infection are called pre-exposure prophylaxis (PrEP). Some people may have trouble following a PrEP plan because it involves either taking medicine everyday by mouth or getting injections (shots) often.
MK-8527 is a study medicine designed to prevent HIV-1 infection. MK-8527 is different from standard (usual) PrEP because it is taken once a month, by mouth, as a tablet.
The goal of this study is to learn if taking a higher-than-normal dose of MK-8527 increases the QT interval (a measure of heart rhythm) by a certain amount.
Conditions: Healthy.
Primary outcome: Change from Baseline in QT interval corrected for heart rate (QTc) following MK-8527 administration.
Enrollment: 42 participants.
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 42 participants or records.
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