Clinical trial NCT04024150: Pregnancy, Anti-integrase and Lymphocyte Repertoire of the Newborn
Official title: Impact of in Utero Exposure to Anti-integrase Antiretrovirals on the Newborn Immune System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anti-integrases
Keywords: Anti-integrases treatment
Antiretroviral treatment
Pregnancy
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2019-07-18
Enrollment: 29
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Newborn immunity
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Colombes
country: France
facility: AP-HP, Hôpital Louis Mourier
city: Paris
country: France
facility: AP-HP, Hôpital de la Pitié Salpêtrière
city: Paris
country: France
facility: AP-HP, Hôpital Cochin
city: Paris
country: France
facility: AP-HP, Hôpital Necker
city: Paris
country: France
facility: AP-HP, Hôpital Bichat-Claude Bernard
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Stéphane Blanche, MD-PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
name: Jean-Pierre de Villartay
role: STUDY_DIRECTOR
References:
citation: 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.