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N/A
N/A
N/A
Not Enrolling
Both
HIV Infections, Central Nervous System Diseases

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Trial Information


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 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.

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 and psychiatric examinations, neuropsychologic test, neuroimaging, and CSF
sampling will be performed once a year for a total of 3 evaluations.

Inclusion Criteria


-INCLUSION CRITERIA:

1. HIV disease acquired in the first decade of life.

2. 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

3. For children greater than 7 years, ability to give assent if developmentally
appropriate.

EXCLUSION CRITERIA:

1. 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.

2. 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:

1. Increased intracranial pressure (head imaging and neurologic examination to be
performed prior to LP)

2. Spinal cord lesion (to be screened by neurologic examination; spine imaging if
clinically indicated)

3. Platelet count less than 75,000/mm(3)

4. Abnormal PT/PTT

5. Focal suppuration at puncture site

Type of Study:

Observational

Study Design:

N/A

Principal Investigator

Rohan Hazra, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

050150

NCT ID:

NCT00110331

Start Date:

May 2005

Completion Date:

Related Keywords:

  • HIV Infections
  • Central Nervous System Diseases
  • Encephalopathy
  • Neuroimaging
  • Cognition
  • Neuroinflammation
  • Opportunistic Infections
  • HIV
  • Central Nervous System Disease
  • Bipolar Disorder
  • Attention Deficit Hyperactivity Disorder
  • ADHD
  • Major Depression
  • Psychosis
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Central Nervous System Diseases
  • Nervous System Diseases

Name

Location

National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland  20892