A Sub-study of PREDICT Neurodevelopment Protocol

The Neurodevelopment in Normal Children in Cambodia and Thailand

To determine the neurodevelopment (ND) in normal children in Thailand and Cambodia and to use this group to compare the neurodevelopmental changes over time to the HIV-infected children with and without HAART (main study).

Normative data are mostly, if not exclusively, obtained from children in the Western world. Comparing data from Asian children to these norms may lead to the wrong interpretation of the results, as it does not account for cultural differences, translation issues and a possibly different education system. Therefore it is essential to include a matched control group to evaluate the participants of the study to the fullest extent in terms of cognition, memory, behavior and fine motor skills, in all age groups over the full course of the study.

Inclusion Criteria: for HIV negative exposed children

• Child from a HIV-positive mother
• Documented negative test for HIV-1 infection
• Between the age from 1-15 years
• Caregiver of the subject is willing and able to sign informed consent, prior to the study
• Thai or Cambodian origin

HIV negative and not HIV exposed:

Inclusion

• Child from a HIV-negative mother (by history)
• Documented negative test for HIV-1 infection
• Between the age from 1-15 years
• Caregiver of the subject is willing and able to sign informed consent, prior to the study
• Thai or Cambodian origin

Exclusion Criteria: for HIV negative exposed children

• The inability of the caregivers to understand the nature and extend of the trial and the procedure required
• Patients with psychiatric disorder
• Patients with a syndrome that affects cognitive performance

for HIV negative and not HIV exposed

• The inability of the caregivers to understand the nature and extent of the trial and the procedure required
• Patients with psychiatric disorder
• Patients with a syndrome that affects cognitive performance