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Breast milk drug check: HIV med levels measured in nursing moms

NCT ID NCT07086079

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 enrolled 12 healthy lactating women to measure how much of the HIV drug MK-8591A (doravirine and islatravir) gets into breast milk. Participants took one oral tablet and provided breast milk and blood samples over 24 hours. The goal was to estimate the dose a nursing infant might receive, helping guide future safety recommendations.

What this could mean

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

Active substance
MK-8591A (doravirine and islatravir combination tablet)
What this could lead to
If successful, this study could help doctors understand whether MK-8591A is safe for breastfeeding mothers and their infants.
What could go wrong
This is a very small, early-stage study in healthy women, not people with HIV. Results may not apply to real-world patients, and the drug could still be unsafe for infants.

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

12 people

The number who actually took part.

Started

Sep 2025

Finished

Feb 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 main inclusion criteria include but are not limited to the following: * Is at least 6-weeks postpartum at the time of administration of study drug, following the delivery of a healthy singleton neonate * Is willing and able to express breast milk using an electric pump prior to study drug administration and is expected to be able to express at least 4 times over a 24-hour period after study drug administration Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, psychiatric, or major neurological (including stroke and chronic seizures) abnormalities or diseases * Has had mastitis within 30 days prior to administration of study drug

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As listed by the trial registrant

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

Healthy

Contacts and locations

Locations

  • QPS Missouri ( Site 0001)

    Springfield, Missouri, 65802, United States

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