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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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8 August 2016 |
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Main ID: |
NCT02570334 |
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Date of registration:
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06/10/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Cross Sectional Evaluation of the Development in Children Age 4 to 7 Infected or Exposed to HIV From the ANRS 12140 Cohort (Pediacam)
PediacamDEV |
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Scientific title:
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A Cross Sectional Evaluation of the Development in Children Age 4 to 7 Infected or Exposed to HIV From the ANRS 12140 Cohort (Pediacam) |
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Date of first enrolment:
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December 2015 |
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Target sample size:
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400 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02570334 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening
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Phase:
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N/A
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Countries of recruitment
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Cameroon
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Contacts
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Name:
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Mathurin Cyrille TEJIOKEM, MD, PhD |
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Address:
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Telephone:
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222 22 23 10 15 |
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Email:
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tejiokem@pasteur-yaounde.org |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Children included in the Pediacam cohort and age 4 to 7
- Parent or guardian written informed consent obtained
Exclusion Criteria:
Age minimum:
4 Years
Age maximum:
7 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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HIV-uninfected Children
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Children Exposed to HIV
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HIV
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Intervention(s)
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Other: HIV-infected children initiated antiretroviral treatment within the first 7 months of life
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Primary Outcome(s)
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Global motor development (Touwen test), global cognitive development (K-ABC II test), visual (Log Mar Char) and hearing (full ear nose and throat examination) impediments
[Time Frame: 4-7 years of age]
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Secondary Outcome(s)
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Prognostic factors and consequences of HIV-associated neuro-cognitive impairments
[Time Frame: 4-7 years of age]
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Effect of early ARV (<3 months) versus differed ARV (between 3 and 7 months) on neurocognitive impairments
[Time Frame: 4-7 years of age]
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Compared frequency of motor, cognitive and sensorial impairments between infected and uninfected children
[Time Frame: 4-7 years of age]
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Secondary ID(s)
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ANRS 12322 PediacamDEV
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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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