Clinical trial NCT02570334: A Cross Sectional Evaluation of the Development in Children Age 4 to 7 Infected or Exposed to HIV From the ANRS 12140 Cohort (Pediacam)
Official title: 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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HIV
HIV-uninfected Children
Children Exposed to HIV
Keywords: early ART
neurocognitive evaluation
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
Collaborators: name: Centre Pasteur du Cameroun
name: Hopital Universitaire Robert-Debre
name: Institut de Recherche pour le Developpement
name: Centre Mère et Enfant de la Fondation Chantal Biya
name: Hospital General De Douala
name: Centre Hospitalier D'essos
name: Inserm U1018, Equipe 4 VIH & IST
First posted: 2015-10-07
Enrollment: 400
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

-

Primary outcomes:
measure: 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
timeFrame: 4-7 years of age
Secondary outcomes:
measure: Compared frequency of motor, cognitive and sensorial impairments between infected and uninfected children
timeFrame: 4-7 years of age
measure: Effect of early ARV (<3 months) versus differed ARV (between 3 and 7 months) on neurocognitive impairments
timeFrame: 4-7 years of age
measure: Prognostic factors and consequences of HIV-associated neuro-cognitive impairments
timeFrame: 4-7 years of age
Other outcomes:
Locations:
city: Douala
country: Cameroon
facility: Hôpital de Laquintinie
city: Yaounde
country: Cameroon
facility: Centre Hospitalier d'Essos
city: Yaounde
country: Cameroon
facility: Hôpital de la Fondation Mère-enfant Chantal Biya
Study officials:
References: