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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)

Not Applicable
Conditions
HIV-uninfected Children
HIV
Children Exposed to HIV
Interventions
Other: HIV-infected children initiated antiretroviral treatment within the first 7 months of life
Registration Number
NCT02570334
Lead Sponsor
ANRS, Emerging Infectious Diseases
Brief Summary

This study aims to perform a comprehensive neuro-cognitive evaluation of the 4-7 year old children from the Pediacam cohort (ANRS 12140 /12225, NCT02043418). It is expected thereby to provide complementary information to the trials CHER and PREDICT on the long term development of (1) HIV-infected children according to age at ARV initiation and (2) HIV exposed but not infected children, all compared with the control group of children uninfected, unexposed to HIV.

Detailed Description

Cognitive, motor and sensorial impairments associated to HIV infection have been and remain important concerns in children. The advent of ARV has reduced the frequency and the extent of HIV-related encephalopathys, but literature suggests that more limited impairments remain (CHER and PREDICT trials). These neuro-cognitive disorders might constitute an important public health problem in sub-Saharan Africa where a high percentage of children born to HIV+ women live. Nevertheless,the knowledge on their long-term consequences on children development in this context remains limited. Data on the burden of cognitive, motor and sensorial impairment in resource-limited settings as well as on the interaction with other factors that could also impair children development are scarse.

The Pediacam cohort gives the opportunity to better understand the development of children born to HIV-infected mothers - infected by HIV or not - followed up from birth and living in sub-Saharan Africa.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
400
Inclusion Criteria
  • Children included in the Pediacam cohort and age 4 to 7
  • Parent or guardian written informed consent obtained
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Exclusion Criteria
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
HIV-unexposed uninfected childrenHIV-infected children initiated antiretroviral treatment within the first 7 months of lifeChildren born to HIV-uninfected mothers
HIV-infected children diagnosed before 7 months of lifeHIV-infected children initiated antiretroviral treatment within the first 7 months of lifeHIV-infected children diagnosed before 7 months of life
HIV-exposed uninfected childrenHIV-infected children initiated antiretroviral treatment within the first 7 months of lifeHIV-uninfected children born to HIV-infected mothers
Primary Outcome Measures
NameTimeMethod
Global motor development (Touwen test), global cognitive development (K-ABC II test), visual (Log Mar Char) and hearing (full ear nose and throat examination) impediments4-7 years of age

Frequency of cognitive, motor and sensorial impairments in 4-7 year old children born to HIV+ mothers who received early treatment in the first 7 months of life

Secondary Outcome Measures
NameTimeMethod
Effect of early ARV (<3 months) versus differed ARV (between 3 and 7 months) on neurocognitive impairments4-7 years of age

long term effect of early ARV (\<3 months) versus differed ARV (between 3 and 7 months) on cognitive, motor and sensorial impairments in HIV+ children

Prognostic factors and consequences of HIV-associated neuro-cognitive impairments4-7 years of age

prognostic factors and describe consequences of HIV-associated neuro-cognitive impairments on children social life

Compared frequency of motor, cognitive and sensorial impairments between infected and uninfected children4-7 years of age

long term effect of HIV and/or PMTCT exposure on children exposed but not infected with HIV. Results of cognitive, motor and sensorial (hearing and visual) evaluations will be compared among cohorts.

Trial Locations

Locations (3)

Centre Hospitalier d'Essos

🇨🇲

Yaounde, Cameroon

Hôpital de Laquintinie

🇨🇲

Douala, Cameroon

Hôpital de la Fondation Mère-enfant Chantal Biya

🇨🇲

Yaounde, Cameroon

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