National Cohort of Children Born to HIV-positive Mothers (EPF)
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|ClinicalTrials.gov Identifier: NCT03306251|
Recruitment Status : Recruiting
First Posted : October 11, 2017
Last Update Posted : April 30, 2021
|Condition or disease|
|Mother to Child Transmission of HIV|
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 Type :||Observational|
|Estimated Enrollment :||5200 participants|
|Official Title:||ANRS CO11 : National Cohort of Children Born to HIV-positive Mothers|
|Study Start Date :||June 2005|
|Estimated Primary Completion Date :||March 2023|
|Estimated Study Completion Date :||March 2023|
- Efficacy of PMTCT strategies by measuring rate of mother to child transmission of HIV [ Time Frame: At birth up to 24 months ]Number of infected children (HIV RNA >50c/mL or Positive serology) reported on the total number of children
- Immuno-virological response during pregnancy [ Time Frame: At inclusion up to childbirth ]HIV ARN <50c/mL, CD4 cells count>500 cells/mL
- Tolerance and toxicity of different kind of MTCT prophylaxis during pregnancy [ Time Frame: At inclusion up to childbirth ]incidence of pathologies during pregnancy
- Impact of different kind of MTCT prophylaxis on childbirth [ Time Frame: At delivery ]Childbirth mode (Number of emergency Caesarean section, Number of planned caesarean section)
- Impact of different kind of MTCT prophylaxis during pregnancy on uninfected children [ Time Frame: At childbirth, 1 month, 3 months, 6 months, 12 months and 18-24 months ]Clinical abnormalities (occurrence of adverse events)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03306251
|Contact: Josiane WARSZAWSKIfirstname.lastname@example.org|
|Contact: Maud BROSSARDemail@example.com|
|Principal Investigator:||Josiane WARSZAWSKI||CESP INSERM U1018|