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| Sponsored by: |
National Cancer Institute (NCI) |
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00110331 |
Purpose
This study will examine how HIV affects the brain and nervous system, learning, and behavior in children on highly active antiretroviral therapy (HAART). Although HAART has resulted in fewer HIV-infected children getting sick and even fewer dying from AIDS, many children on this treatment regimen develop significant brain or nervous system problems, such as learning difficulties, attention problems, hyperactivity, and depression.
People who acquired HIV disease in the first decade of life and who have evidence of central nervous system (CNS) disease (e.g., encephalopathy, CNS compromise, ADHD, bipolar disease, major depression or psychosis) may be eligible for this study. Candidates are screened with a medical history, physical examination, neuropsychological testing and a CT scan of the head, if one has not been done within 12 months of entering the study.
Participants undergo the following tests and procedures:
Some blood and spinal fluid samples from participants are stored for possible future studies related to HIV research
| Condition |
|
HIV Infections Central Nervous System Diseases |
| MedlinePlus related topics: | AIDS Depression Neurologic Diseases Nuclear Scans |
| Study Type: | Observational |
| Official Title: | A Study of Central Nervous System Disease in Pediatric HIV in the HAART Era |
| Estimated Enrollment: | 40 |
| Study Start Date: | May 2005 |
| Estimated Study Completion Date: | March 2006 |
Background:
Highly active antiretroviral therapy (HAART) has altered the natural history of HIV disease in children.
A significant minority of HIV-infected children has evidence of ongoing CNS disease.
Specific markers for CNS disease, factors predictive of risk for neurological decline, and pathophysiologic mechanisms have not yet been identified in HIV-infected children.
Objective:
To explore the clinical features (neurological exam, neuropsychological evaluation, and neuroimaging), viral and neuroinflammatory factors, anatomic changes (brain MRI) and patterns of brain metabolites (1H-MRS) associated with HIV-related CNS disease in HIV-infected children in the HAART era.
Eligibility:
HIV disease acquired in the first decade of life.
Evidence of CNS disease (classification of encephalopathy or CNS compromise or diagnosis of ADHD, bipolar disease, major depression, or psychosis).
Design:
Serial neurologic examinations, neuropsychologic test, neuroimaging, and CSF sampling will be performed once a year for a total of 3 evaluations.
Eligibility
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
-INCLUSION CRITERIA:
Evidence of CNS disease (at least one of the following):
EXCLUSION CRITERIA:
Lumbar Puncture Exclusion Criteria:
Contacts and Locations| Contact: NCI Referral Office | ncissc@mail.nih.gov |
| United States, Maryland | |||||
| National Cancer Institute (NCI) | Recruiting | ||||
| Bethesda, Maryland, United States, 20892 | |||||
More Information
NIH Clinical Center Detailed Web Page 
  |
| Study ID Numbers: | 050150, 05-C-0150 |
| First Received: | May 5, 2005 |
| Last Updated: | March 3, 2008 |
| ClinicalTrials.gov Identifier: | NCT00110331 |
| Health Authority: | United States: Federal Government |
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