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Breast milk drug levels measured to protect infants from HIV meds

NCT ID NCT05648201

Knowledge-focused Sponsor: Radboud University Medical Center 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study looked at how five common HIV drugs enter breast milk in 20 healthy women who were finishing breastfeeding. The goal was to find out if the drug levels could be too high (risking infant side effects) or too low (risking drug resistance if the baby gets HIV). Participants took a single dose of one of the drugs, and researchers measured drug concentrations in blood and milk.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

20 people

The number who actually took part.

Started

Mar 2023

Finished

Apr 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 50 years

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: * At least 18 years of age at the moment of screening * At least 10 days post partum * At the end of breastfeeding period; subject is able to produce breastmilk at least two times a day and is no longer feeding infant at start of study * Able and willing to sign an informed consent Exclusion Criteria: * Relevant co-medication or comorbidity that might interfere with drug absorption, distribution, metabolism or excretion * Inability to take drugs according to the instructions (i.e. with food) * Presence of positive HIV screening or HIV RNA * Presence of HBsAg or HBcAg without anti-HBs * Presence of grade III/IV anaemia (i.e. Hb \<4.6 mmol/L or \<7.4 g/dL). * Presence of hereditary forms of severe galactose intolerance, total lactase deficiency or glucose-galactose malabsorption

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Conditions

The condition(s) this trial relates to.

AIDS HIV infectious disease

As listed by the trial registrant

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

HIV

Contacts and locations

Locations

  • Radboudumc

    Nijmegen, Netherlands

More trials for these conditions

Other studies related to the condition(s) this trial covers.