A Sub-study of PREDICT Neurodevelopment Protocol

The HIV Netherlands Australia Thailand Research Collaboration

Status: Completed

Conditions: Neurocognitive Development

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT02406768

HIV-NAT 035.4

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 300 patients

Sex: All

Ages: 1 to 15 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

300 participants in 2 patient groups

HIV negative unexposed

Description:

HIV negative controls

HIV negative exposed

Description:

HIV-negative children born to HIV-infected mothers