A Sub-study of PREDICT Neurodevelopment Protocol

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-08-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Neurocognitive Development

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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HIV negative unexposed

HIV negative controls

No interventions assigned to this group

HIV negative exposed

HIV-negative children born to HIV-infected mothers

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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

* 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

Minimum Eligible Age

1 Year

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes