Pregnancy, Anti-integrase and Lymphocyte Repertoire of the Newborn

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04024150

Acronym

RAGIIF

Enrollment

Registered

2019-07-18

Start date

2019-12-04

Completion date

2021-01-14

Last updated

2026-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anti-integrases

Keywords

Anti-integrases treatment, Antiretroviral treatment, Pregnancy

Brief summary

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.

Detailed description

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.

Interventions

BIOLOGICALBlood test

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

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Newborn immunity	18 months	T cells immune repertoire integrity

Countries

France

Contacts

PRINCIPAL_INVESTIGATORStéphane Blanche, MD-PhD

Assistance Publique - Hôpitaux de Paris

STUDY_DIRECTORJean-Pierre de Villartay

Institut National de la Santé Et de la Recherche Médicale, France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026