Status:
COMPLETED
Central Nervous System Disease in HIV-infected Children on HAART
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
HIV Infections
Central Nervous System Diseases
Eligibility:
All Genders
Brief Summary
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-infec...
Detailed Description
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 disea...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- HIV disease acquired in the first decade of life.
- Evidence of CNS disease (at least one of the following):
- Classification of encephalopathy or CNS compromise.
- Diagnosis of ADHD, bipolar disease, major depression, or psychosis
- For children greater than 7 years, ability to give assent if developmentally appropriate.
- EXCLUSION CRITERIA:
- Inability or unwillingness to provide informed consent for subjects greater than 18 years, and inability or unwillingness of one parent / legal guardian to provide consent for subjects less than 18 years.
- Clinically significant, unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction) which in the judgment of the Principal Investigator or Chairpersons would compromise the patient's ability to tolerate this study or is likely to interfere with the study procedures or results
- Lumbar Puncture Exclusion Criteria:
- Increased intracranial pressure (head imaging and neurologic examination to be performed prior to LP)
- Spinal cord lesion (to be screened by neurologic examination; spine imaging if clinically indicated)
- Platelet count less than 75,000/mm(3)
- Abnormal PT/PTT
- Focal suppuration at puncture site
Exclusion
Key Trial Info
Start Date :
May 3 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 9 2014
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00110331
Start Date
May 3 2005
End Date
September 9 2014
Last Update
December 12 2019
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892