National Cohort of Children Born to HIV-positive Mothers

• Conditions: Mother to Child Transmission of HIV

• Registration Number: NCT03306251
• Lead Sponsor: ANRS, Emerging Infectious Diseases

Brief Summary

The purpose of this study is to provide a surveillance system to monitor changes in the rate of mother to child HIV transmission and preventive practices in France and especially to identify the occurrence of toxicity in children exposed perinatally to antiretroviral drugs.

Detailed Description

The goal of the CO11 national cohort is to provide with CO1 a wider surveillance system to monitor changes in the rate of mother to child transmission and preventive practices in France and especially to identify the occurrence of toxicity in children exposed perinatally to antiretroviral drugs.

The CO11 EPF enrolle HIV infected women who delivery in maternity generally smaller than CO1 maternity (15 sites in Paris area, 35 in mainland France and 4 in the DOM).

Maternal clinical, biological and therapeutic data before and during pregnancy were collected at delivery, with simplified questionnaires.

The children are examined clinically and biologically at birth, 6, 12 and 24 months.

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2016-09-20
• Study First Submitted QC: 2017-10-04
• Study First Posted: 2017-10-11
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-29
• Last Update Posted: 2021-04-30
• Primary Completion: 2023-03
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 5200

Inclusion Criteria

• pregnant women >= 18 years
• infected with HIV1 and/or HIV2

Exclusion Criteria

• guardianship or judicial or administrative detention

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy of PMTCT strategies by measuring rate of mother to child transmission of HIV	At birth up to 24 months	Number of infected children (HIV RNA \>50c/mL or Positive serology) reported on the total number of children

Secondary Outcome Measures

Name	Time	Method
Immuno-virological response during pregnancy	At inclusion up to childbirth	HIV ARN \<50c/mL, CD4 cells count\>500 cells/mL
Impact of different kind of MTCT prophylaxis on childbirth	At delivery	Childbirth mode (Number of emergency Caesarean section, Number of planned caesarean section)
Tolerance and toxicity of different kind of MTCT prophylaxis during pregnancy	At inclusion up to childbirth	incidence of pathologies during pregnancy
Impact of different kind of MTCT prophylaxis during pregnancy on uninfected children	At childbirth, 1 month, 3 months, 6 months, 12 months and 18-24 months	Clinical abnormalities (occurrence of adverse events)

Trial Locations

Locations (45)

CHU Hôpital Nord; 🇫🇷 Amiens, France

Centre Hospitalier Universitaire; 🇫🇷 Limoges, France

Centre Hosipitalier; 🇫🇷 Annecy, France

Centre Hospitalier Robert Ballanger; 🇫🇷 Aulnay, France

Centre Hospitalier Général de Bastia; 🇫🇷 Bastia, France

Centre Hospitalier de la Côte Basque; 🇫🇷 Bayonne, France

CHRU Saint Jacques; 🇫🇷 Besançon, France

Groupe Hospitalier Pellegrin; 🇫🇷 Bordeaux, France

Centre Hospitalier Régional Universitaire de Brest; 🇫🇷 Brest, France

Centre hospitalier de Béziers; 🇫🇷 Béziers, France

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