Status:
COMPLETED
Pregnancy, Anti-integrase and Lymphocyte Repertoire of the Newborn
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
URC-CIC Paris Descartes Necker Cochin
Conditions:
Anti-integrases
Eligibility:
All Genders
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 an...
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 preg...
Eligibility Criteria
Inclusion
- 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
- Prematurity less than 36 weeks of gestation.
- Organ dysfunction.
- Acute or chronic fetal distress, need for hospitalization in neonatology, malformation syndrome.
Key Trial Info
Start Date :
December 4 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 14 2021
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT04024150
Start Date
December 4 2019
End Date
January 14 2021
Last Update
September 12 2025
Active Locations (5)
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1
AP-HP, Hôpital Louis Mourier
Colombes, France, 92700
2
AP-HP, Hôpital de la Pitié Salpêtrière
Paris, France, 75013
3
AP-HP, Hôpital Cochin
Paris, France, 75014
4
AP-HP, Hôpital Necker
Paris, France, 75015