Pregnancy, Anti-integrase and Lymphocyte Repertoire of the Newborn

Anti-integrases Clinical Trial

— RAGIIF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04024150
• Other study ID #: APHP190394
• Secondary ID: 2019-A00926-51
• Status: Completed
• Start date: December 4, 2019
• Est. completion date: January 14, 2021

Study information

• Verified date: March 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: January 14, 2021
• Est. primary completion date: January 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Anti-integrases

Intervention

Biological:
• Blood test
Single blood sample of 2 ml at birth on the occasion of blood sampling routine checkup

Locations

Country	Name	City	State
France	AP-HP, Hôpital Louis Mourier	Colombes
France	AP-HP, Hôpital Bichat-Claude Bernard	Paris
France	AP-HP, Hôpital Cochin	Paris
France	AP-HP, Hôpital de la Pitié Salpêtrière	Paris
France	AP-HP, Hôpital Necker	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Newborn immunity	T cells immune repertoire integrity	18 months