Pregnancy, Anti-integrase and Lymphocyte Repertoire of the Newborn

NCT04024150 | Completed

• 2 other identifiers: APHP1903942019-A00926-51
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 5

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.

Conditions

Anti-integrases

Keywords

Anti-integrases treatment; Antiretroviral treatment; Pregnancy

Outcome Measures

Primary Outcomes (1)

• Newborn immunity

  T cells immune repertoire integrity

  18 months

Study Arms (2)

Newborns exposed

Newborns exposed in-utero to raltegravir

Biological: Blood test

Newborns controls

Newborns exposed to antiretroviral therapy without anti-integrase

Biological: Blood test

Interventions

Blood test BIOLOGICAL

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

Newborns controls; Newborns exposed

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• Prematurity less than 36 weeks of gestation.
• Organ dysfunction.
• Acute or chronic fetal distress, need for hospitalization in neonatology, malformation syndrome.

Sponsors & Collaborators

• URC-CIC Paris Descartes Necker Cochin: collaborator
• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (5)

AP-HP, Hôpital Louis Mourier

Colombes, 92700, France

Location

AP-HP, Hôpital de la Pitié Salpêtrière

Paris, 75013, France

Location

AP-HP, Hôpital Cochin

Paris, 75014, France

Location

AP-HP, Hôpital Necker

Paris, 75015, France

Location

AP-HP, Hôpital Bichat-Claude Bernard

Paris, 75018, France

Location

Related Publications (1)

• 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.

  PMID: 36343360 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Serum

MeSH Terms

Interventions

Hematologic Tests

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Stéphane Blanche, MD-PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

• Jean-Pierre de Villartay

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

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2019
• First Posted: July 18, 2019
• Study Start: December 4, 2019
• Primary Completion: January 14, 2021
• Study Completion: January 14, 2021
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)