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Breastfeeding moms needed for HIV drug study

NCT ID NCT06580587

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

13 people

The number who actually took part.

Started

Apr 2025

Finished

Mar 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: The key inclusion criteria include but are not limited to the following: * Is at least 6 weeks postpartum at the time of administration of study intervention, following the delivery of a healthy singleton neonate * Is willing and able to express breast milk at least twice daily for at least 120 hours after enrollment * Is willing to discontinue breastfeeding from the time of administration of study intervention until at least 6 weeks following the administration of study intervention. This includes the avoidance of both directly breastfeeding and the administration of breast milk pumped during the above-specified time frame to the infant. Is willing to confirm with the site that the infant is able to bottle feed (breast milk) prior to Day 1 and that alternative nutrition (i.e., previously stored breast milk or infant formula) is available for feeding the infant through the 6-week post dose period Exclusion Criteria: The key exclusion criteria include but are not limited to the following * Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, psychiatric, or major neurological (including stroke and chronic seizures) abnormalities or diseases * Had mastitis within 30 days prior to administration of study drug * Has a positive pregnancy test at the time of screening or prior to treatment allocation

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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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