A Cross Sectional Evaluation of the Development in Children Age 4 to 7 Infected or Exposed to HIV From the ANRS 12140 Cohort (Pediacam)

Study Overview
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Brief Summary
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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
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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.

Official 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)

Conditions
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HIV, HIV-uninfected Children, Children Exposed to HIV

Intervention / Treatment
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* Other: HIV-infected children initiated antiretroviral treatment within the first 7 months of life


Participation Criteria
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Eligibility 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: -

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HIV-infected children diagnosed before 7 months of life<br>HIV-infected children diagnosed before 7 months of life | Other: HIV-infected children initiated antiretroviral treatment within the first 7 months of life<br>* All arms will recieve a thourough clinical evaluation : 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 as well as a questionnaire concerning socioeconomic situation, medical history of the child and mother, and HIV treatment and follow up information.<br>|
| Experimental: HIV-exposed uninfected children<br>HIV-uninfected children born to HIV-infected mothers | Other: HIV-infected children initiated antiretroviral treatment within the first 7 months of life<br>* All arms will recieve a thourough clinical evaluation : 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 as well as a questionnaire concerning socioeconomic situation, medical history of the child and mother, and HIV treatment and follow up information.<br>|
| Experimental: HIV-unexposed uninfected children<br>Children born to HIV-uninfected mothers | Other: HIV-infected children initiated antiretroviral treatment within the first 7 months of life<br>* All arms will recieve a thourough clinical evaluation : 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 as well as a questionnaire concerning socioeconomic situation, medical history of the child and mother, and HIV treatment and follow up information.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 4-7 years of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compared frequency of motor, cognitive and sensorial impairments between infected and uninfected children | 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. | 4-7 years of age | 
| Effect of early ARV (<3 months) versus differed ARV (between 3 and 7 months) on neurocognitive impairments | 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 | 4-7 years of age | 
| Prognostic factors and consequences of HIV-associated neuro-cognitive impairments | prognostic factors and describe consequences of HIV-associated neuro-cognitive impairments on children social life | 4-7 years of age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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early ART, neurocognitive evaluation