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National Cohort of Children Born to HIV-positive Mothers

ANRS CO11 : National Cohort of Children Born to HIV-positive Mothers

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03306251
Acronym
EPF
Enrollment
5200
Registered
2017-10-11
Start date
2005-06-30
Completion date
2023-03-31
Last updated
2021-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mother to Child Transmission of HIV

Keywords

HIV, Pregnancy, Prevention of mother-to-child transmission

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.

Interventions

None listed

Sponsors

ANRS, Emerging Infectious Diseases
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* guardianship or judicial or administrative detention

Design outcomes

Primary

MeasureTime frameDescription
Efficacy of PMTCT strategies by measuring rate of mother to child transmission of HIVAt birth up to 24 monthsNumber of infected children (HIV RNA \>50c/mL or Positive serology) reported on the total number of children

Secondary

MeasureTime frameDescription
Immuno-virological response during pregnancyAt inclusion up to childbirthHIV ARN \<50c/mL, CD4 cells count\>500 cells/mL
Tolerance and toxicity of different kind of MTCT prophylaxis during pregnancyAt inclusion up to childbirthincidence of pathologies during pregnancy
Impact of different kind of MTCT prophylaxis on childbirthAt deliveryChildbirth mode (Number of emergency Caesarean section, Number of planned caesarean section)
Impact of different kind of MTCT prophylaxis during pregnancy on uninfected childrenAt childbirth, 1 month, 3 months, 6 months, 12 months and 18-24 monthsClinical abnormalities (occurrence of adverse events)

Countries

France, French Guiana, Guadeloupe, Martinique

Contacts

Primary ContactJosiane WARSZAWSKI
josiane.warszawski@inserm.fr
Backup ContactMaud BROSSARD
maud.brossard@inserm.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026