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)

ANRS, Emerging Infectious Diseases

Status: Unknown

Conditions: HIV-uninfected Children; HIV; Children Exposed to HIV

Treatments: Other: HIV-infected children initiated antiretroviral treatment within the first 7 months of life

Study type: Interventional

Funder types: Other

Identifiers

NCT02570334

ANRS 12322 PediacamDEV

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 4 to 7 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children included in the Pediacam cohort and age 4 to 7
• Parent or guardian written informed consent obtained

Exclusion criteria

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 3 patient groups

HIV-infected children diagnosed before 7 months of life

Experimental group

Description:

HIV-infected children diagnosed before 7 months of life

Treatment:

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

HIV-exposed uninfected children

Experimental group

Description:

HIV-uninfected children born to HIV-infected mothers

Treatment:

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

HIV-unexposed uninfected children

Experimental group

Description:

Children born to HIV-uninfected mothers

Treatment:

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