Pregnancy, Anti-integrase and Lymphocyte Repertoire of the Newborn

Completed

• Conditions: Anti-integrases
• Interventions: Biological: Blood test

• Registration Number: NCT04024150
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2019-07-02
• Study First Submitted QC: 2019-07-16
• Study First Posted: 2019-07-18
• Study Start: 2019-12-04
• Primary Completion: 2021-01-14
• Study Completion: 2021-01-14
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-20
• Last Update Posted: 2023-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Newborns exposed	Blood test	Newborns exposed in-utero to raltegravir
Newborns controls	Blood test	Newborns exposed to antiretroviral therapy without anti-integrase

Primary Outcome Measures

Name	Time	Method
Newborn immunity	18 months	T cells immune repertoire integrity

Trial Locations

Locations (5)

AP-HP, Hôpital Cochin; 🇫🇷 Paris, France

AP-HP, Hôpital Bichat-Claude Bernard; 🇫🇷 Paris, France

AP-HP, Hôpital Necker; 🇫🇷 Paris, France

AP-HP, Hôpital de la Pitié Salpêtrière; 🇫🇷 Paris, France

AP-HP, Hôpital Louis Mourier; 🇫🇷 Colombes, France