Central Nervous System Disease in HIV-infected Children on HAART
|First Received Date ICMJE||May 5, 2005|
|Last Updated Date||June 30, 2017|
|Start Date ICMJE||May 3, 2005|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00110331 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Central Nervous System Disease in HIV-infected Children on HAART|
|Official Title ICMJE||Not Provided|
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
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.
To explore the clinical features (neurological and psychiatric exams, 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.
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).
Serial neurologic and psychiatric examinations, neuropsychologic test, neuroimaging, and CSF sampling will be performed once a year for a total of 3 evaluations.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Estimated Completion Date||September 9, 2014|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Lumbar Puncture Exclusion Criteria:
|Ages||Child, Adult, Senior|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00110331|
|Other Study ID Numbers ICMJE||050150
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Cancer Institute (NCI)|
|Collaborators ICMJE||Not Provided|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||September 9, 2014|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP