Breastfeeding moms needed for HIV drug study

NCT ID NCT06580587

Completed Knowledge-focused Sponsor: Merck Sharp & Dohme LLC Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This completed Phase 1 study tested how the experimental HIV prevention drug MK-8527 moves into breast milk. Thirteen healthy lactating women took a single oral dose, then provided milk and blood samples over five days. The goal was to measure how much drug reaches the baby through breastfeeding, which is important for future safe use in HIV prevention.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: MK-8527
What this could lead to: If successful, this study could help determine safe dosing of MK-8527 for HIV prevention in breastfeeding women.
What could go wrong: This is a very early Phase 1 study with only 13 participants. It measures drug levels, not effectiveness or safety for the baby.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

HIV infectious disease prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HEALTHY HIV PRE-EXPOSURE PROPHYLAXIS

Contacts and locations

Locations

Bio-Kinetic Clinical Applications, LLC dba QPS-MO ( Site 0002)

Springfield, Missouri, 65802, United States
University of Pittsburgh Medical Center Magee-Womens Hospital ( Site 0001)

Pittsburgh, Pennsylvania, 15213, United States

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