Pregnancy, Anti-integrase and Lymphocyte Repertoire of the Newborn (RAGIIF)

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

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 Overview

• Status: Completed
• Conditions: Anti-integrases
• Intervention / Treatment: Biological: Blood test

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 Type: Observational
• Enrollment (Actual): 29

Contacts and Locations

Study Locations

• France
  • Colombes, France, 92700
    • AP-HP, Hôpital Louis Mourier
  • Paris, France, 75014
    • AP-HP, Hôpital Cochin
  • Paris, France, 75013
    • AP-HP, Hôpital de la Pitié Salpêtrière
  • Paris, France, 75015
    • AP-HP, Hôpital Necker
  • Paris, France, 75018
    • AP-HP, Hôpital Bichat-Claude Bernard

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Newborns exposed; Newborns exposed in-utero to raltegravir	Biological: Blood test; Single blood sample of 2 ml at birth on the occasion of blood sampling routine checkup
Newborns controls; Newborns exposed to antiretroviral therapy without anti-integrase	Biological: Blood test; Single blood sample of 2 ml at birth on the occasion of blood sampling routine checkup

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: URC-CIC Paris Descartes Necker Cochin
• Investigators: Principal Investigator: Stéphane Blanche, MD-PhD, Assistance Publique - Hôpitaux de Paris; Study Director: Jean-Pierre de Villartay, Institut National de la Santé Et de la Recherche Médicale, France

Publications and helpful links

General Publications

• de Villartay JP, Pannier E, Sibiude J, Frange P, Tubiana R, Blanche S. Brief Report: T-Cell Receptor alpha Repertoire Diversity at Birth After in utero Exposure to HIV Integrase Strand-Transfer Inhibitors. J Acquir Immune Defic Syndr. 2023 Mar 1;92(3):260-262. doi: 10.1097/QAI.0000000000003130.

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2019
• Primary Completion (Actual): January 14, 2021
• Study Completion (Actual): January 14, 2021

Study Registration Dates

• First Submitted: July 2, 2019
• First Submitted That Met QC Criteria: July 16, 2019
• First Posted (Actual): July 18, 2019

Study Record Updates

• Last Update Posted (Actual): March 9, 2026
• Last Update Submitted That Met QC Criteria: March 6, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Pregnancy; Antiretroviral treatment; Anti-integrases treatment
• Additional Relevant MeSH Terms: Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests
• Other Study ID Numbers: APHP190394; 2019-A00926-51 (Other Identifier: ID RCB number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No