A Sub-study of PREDICT Neurodevelopment Protocol

The HIV Netherlands Australia Thailand Research Collaboration300 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Neurocognitive Development

Eligibility

Sex: ALLMin age: 1 YearMax age: 15 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (10)

National Center for HIV/AIDS, Dermatology and STDs (NCHADS)

Phnom Penh, Cambodia

National Pediatric Hospital

Phnom Penh, Cambodia

Pediatric Infectious Diseases Unit Department of Pediatrics Faculty of Medicine Chulalongkorn University

Bangkok, Bangkok, Thailand

Outcomes

Primary Outcomes

neurodevelopment changes (composite of cognitive, fine motor and behavioral)

measured by cognitive test, fine motor test and behavioral assessment test

Time frame: up to 96 weeks

Data from ClinicalTrials.gov

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