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

Assistance Publique - Hôpitaux de Paris

Status

Completed

Conditions

Anti-integrases

Treatments

Biological: Blood test

Study type

Observational

Funder types

Other

Identifiers

NCT04024150

APHP190394

2019-A00926-51 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

29 patients

Sex

All

Volunteers

No 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.