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Tiny study checks if HIV meds in pregnancy alter Baby's immune system

NCT ID NCT04024150

Knowledge-focused Sponsor: Assistance Publique - Hôpitaux de Paris 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at 29 newborns to see if exposure to a class of HIV drugs called anti-integrases (like raltegravir) in the womb affects their immune system at birth. Researchers compared these babies to those exposed to other HIV medications. The goal was to check the diversity of T cells, a key part of the immune system, using a single blood sample taken at birth.

What this could mean

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

Active substance
anti-integrase antiretroviral drugs (raltegravir, elvitegravir, dolutegravir, bictegravir)
What this could lead to
If successful, this could help doctors understand whether certain HIV medications are safer for the baby's developing immune system during pregnancy.
What could go wrong
This is a very small, completed observational study with only 29 newborns, so results may not apply broadly. It measures immune markers at birth, not long-term health outcomes.

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

29 people

The number who actually took part.

Started

Dec 2019

Finished

Jan 2021

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

Newborns exposed in utero to an antiretroviral therapy and born in the maternities of Paris AP-HP hospitals: Necker, Pitié-Salpétrière, Bichat, Louis Mourier and Cochin (Port-Royal).

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

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: * No parental opposition after information. "Exposed" group : * Newborn at term exposed to raltegravir (RTG) before 8 weeks of gestation and until the end of pregnancy. Children exposed to elvitegravir (ETG), dolutegravir (DTG) or bictegravir (BTG) may be included but will be analyzed separately. "Control" group : \- Term neonate exposed to antiretroviral therapy without anti-integrase. Exclusion Criteria: * Prematurity less than 36 weeks of gestation. * Organ dysfunction. * Acute or chronic fetal distress, need for hospitalization in neonatology, malformation syndrome.

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As listed by the trial registrant

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

Anti-integrases

Contacts and locations

Locations

  • AP-HP, Hôpital Bichat-Claude Bernard

    Paris, 75018, France

  • AP-HP, Hôpital Cochin

    Paris, 75014, France

  • AP-HP, Hôpital Louis Mourier

    Colombes, 92700, France

  • AP-HP, Hôpital Necker

    Paris, 75015, France

  • AP-HP, Hôpital de la Pitié Salpêtrière

    Paris, 75013, France