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Wits RHI

MK8527-007 Study

Infectious Diseases
Short Title: Safety and Pharmacokinetic Study of Oral MK-8527 QM in Participants at Low-Risk for HIV-1 Infection. The MK8527-007 Study is a Phase 2a, randomized, double-blind, placebo-controlled, parallel-group, multicenter clinical trial. The study is evaluating the safety, tolerability, and pharmacokinetics of oral MK-8527, administered once monthly, in adults aged 18 to 65 who are at low risk for HIV-1 infection.

Rationale

With ongoing efforts to improve HIV prevention methods, there is a need for innovative, long-acting solutions that simplify adherence and offer greater flexibility compared to daily oral regimens. The MK8527-007 study evaluates the safety, tolerability, and pharmacokinetics of a once-monthly oral HIV prevention medication, MK-8527, in participants at low risk for HIV-1 infection. This study aims to provide critical insights into the potential of MK-8527 as a convenient and effective option for HIV prevention.

Primary Objectives

  1. Safety and Tolerability: To evaluate the safety and tolerability of MK-8527 at three different doses (3 mg, 6 mg, and 12 mg) administered once monthly (QM) during treatment and through the final follow-up visit.
  2. Adverse Events: To monitor adverse events and any events leading to the discontinuation of the study intervention.

Study Population

The study targets adults aged 18-65 years who are at low risk of HIV-1 infection.

Investigators

Principal Investigator: Dr Nicole Poovan

Latest Update

April 2024

For more details about MK8527-007 study please email rhicomms@wrhi.ac.za

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Research Brief

MK8527-007 Study