Pregnancy, Anti-integrase and Lymphocyte Repertoire of the Newborn
NCT ID: NCT04024150
Last Updated: 2025-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
29 participants
OBSERVATIONAL
2019-12-04
2021-01-14
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Newborns exposed
Newborns exposed in-utero to raltegravir
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
Blood test
Single blood sample of 2 ml at birth on the occasion of blood sampling routine checkup
Interventions
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Blood test
Single blood sample of 2 ml at birth on the occasion of blood sampling routine checkup
Eligibility Criteria
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Inclusion Criteria
* 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
* Organ dysfunction.
* Acute or chronic fetal distress, need for hospitalization in neonatology, malformation syndrome.
ALL
No
Sponsors
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URC-CIC Paris Descartes Necker Cochin
OTHER
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Stéphane Blanche, MD-PhD
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Jean-Pierre de Villartay
Role: STUDY_DIRECTOR
Institut National de la Santé Et de la Recherche Médicale, France
Locations
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AP-HP, Hôpital Louis Mourier
Colombes, , France
AP-HP, Hôpital de la Pitié Salpêtrière
Paris, , France
AP-HP, Hôpital Cochin
Paris, , France
AP-HP, Hôpital Necker
Paris, , France
AP-HP, Hôpital Bichat-Claude Bernard
Paris, , France
Countries
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References
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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.
Other Identifiers
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2019-A00926-51
Identifier Type: OTHER
Identifier Source: secondary_id
APHP190394
Identifier Type: -
Identifier Source: org_study_id
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