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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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10 May 2021 |
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Main ID: |
NCT03306251 |
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Date of registration:
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20/09/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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National Cohort of Children Born to HIV-positive Mothers
EPF |
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Scientific title:
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ANRS CO11 : National Cohort of Children Born to HIV-positive Mothers |
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Date of first enrolment:
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June 2005 |
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Target sample size:
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5200 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03306251 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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France
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French Guiana
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Guadeloupe
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Martinique
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Contacts
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Name:
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Josiane WARSZAWSKI |
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Address:
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Telephone:
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Email:
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josiane.warszawski@inserm.fr |
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Affiliation:
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Name:
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Josiane WARSZAWSKI |
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Address:
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Telephone:
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Email:
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Affiliation:
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CESP INSERM U1018 |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- pregnant women >= 18 years
- infected with HIV1 and/or HIV2
Exclusion Criteria:
- guardianship or judicial or administrative detention
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Mother to Child Transmission of HIV
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Primary Outcome(s)
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Efficacy of PMTCT strategies by measuring rate of mother to child transmission of HIV
[Time Frame: At birth up to 24 months]
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Secondary Outcome(s)
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Tolerance and toxicity of different kind of MTCT prophylaxis during pregnancy
[Time Frame: At inclusion up to childbirth]
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Impact of different kind of MTCT prophylaxis on childbirth
[Time Frame: At delivery]
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Immuno-virological response during pregnancy
[Time Frame: At inclusion up to childbirth]
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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]
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Secondary ID(s)
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ANRS-CO11-EPF
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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