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Small study checks HIV drug levels in breastmilk for safer infant feeding

NCT ID NCT05642481

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 16 mothers with HIV who chose to breastfeed while taking antiretroviral medication. Researchers measured drug levels in the mothers' blood and breastmilk, and in the babies' blood, to see how much medicine the infants received. The goal was to gather information to help guide safe breastfeeding practices for women with HIV.

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.

Participants

16 people

The number who actually took part.

Started

Mar 2023

Finished

Dec 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.

Who is studied

women living with HIV using antiretroviral medication who chose to breastfeed their child

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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 * Patients of at least 18 years of age at the moment of screening * Patients with HIV-1 as documented with positive HIV antibody test, HIV RNA of antigen test * Patients breastfeeding their infant * Patients using antiretrovirals for the treatment of HIV-1 with a marketing authorisation in Europe (table 1 in Appendix) * Patients using current antiretrovirals for a minimum of 2 weeks to assure drug concentrations are in steady state * Patients who are able and willing to sign an informed consent Exclusion Criteria: No exclusion criteria will be used at the screening for the trial.

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Conditions

The condition(s) this trial relates to.

Breast Feeding HIV infectious disease

As listed by the trial registrant

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

HIV-1-infection

Contacts and locations

Locations

  • Amsterdamumc

    Amsterdam, North Holland, Netherlands

  • Erasmusmc

    Rotterdam, South Holland, Netherlands

  • Radboudumc

    Nijmegen, Gelderland, 6525GA, Netherlands

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