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Completed

NCT Number: NCT04024150

Pregnancy, Anti-integrase and Lymphocyte Repertoire of the Newborn

The objective of the study is to evaluate at birth, the diversity of the T repertoire of newborns exposed in utero to anti-integrases in comparison with a control group of children exposed to other antiretroviral drugs.

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Key information

Conditions

Sex eligibility

All sexes

Study type

Observational

Primary location

AP-HP, Hôpital Louis Mourier, Colombes, France

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About this study

Antiretroviral treatment during pregnancy is remarkably effective in preventing the transmission of mother-to-child viruses. Molecules of the class of anti-integrases are still little used during pregnancy, but their prescription is increasing given their intrinsic effectiveness and their overall tolerance profile.

The integrase of HIV-1, responsible for the integration of viral DNA in cellular DNA, has a functional similarity with human RAG1 / 2 proteins, responsible for V (D) J recombination. RAG1 / 2 proteins alteration is associated in human clinic with immune disturbances of varied severity.

The objective of the study is to evaluate at birth, the diversity of the T repertoire of newborns exposed in utero to anti-integrases in comparison with a control group of children exposed to other antiretroviral drugs.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

blood test

Biological

Single blood sample of 2 ml at birth on the occasion of blood sampling routine checkup

Primary outcomes

  1. Newborn immunity

    Time frame: 18 months

    T cells immune repertoire integrity

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

Impact of in Utero Exposure to Anti-integrase Antiretrovirals on the Newborn Immune System

Acronym: RAGIIF

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 18, 2019
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.