Central Nervous System Disease in HIV-infected Children on HAART
| Status: | Completed |
|---|---|
| Conditions: | HIV / AIDS, Neurology |
| Therapuetic Areas: | Immunology / Infectious Diseases, Neurology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 3/31/2019 |
| Start Date: | May 3, 2005 |
| End Date: | September 9, 2014 |
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:
- MRI and MRS scan of the head: These tests use a magnetic field and radio waves to obtain
images of the brain and detect changes in certain brain chemicals that may be affected
by HIV infection. Both procedures are done at the same time. The patient lies on a table
that is moved into the scanner (a narrow cylinder), wearing earplugs to muffle loud
knocking and thumping sounds that occur during the scanning process. The procedure lasts
about 50 to 60 minutes, during which time the patient can communicate with the staff.
- Neuropsychological testing: Patients' thinking and behavior are evaluated with tests to
measure their memory, attention, language, problem-solving, academic, and motor skills
and questionnaires to assess behavioral and emotional functioning, quality of life, and
adherence to HIV medication. Parents are also asked to complete questionnaires assessing
their child's behavioral and emotional functioning, quality of life, important life
events, and adherence to HIV medication.
- Lumbar puncture (spinal tap): Cerebrospinal fluid (CSF) is collected for analysis. For
this procedure, a local anesthetic is given and a needle is inserted in the space
between the bones in the lower back where the CSF circulates below the spinal cord. Some
fluid is collected through the needle. Blood tests and a physical examination are done
before the procedure to make sure it can be done as safely as possible. Patients may
also be sedated to prevent any discomfort.
- Follow-up: The blood tests, MRI and MRS scans and spinal tap are repeated 1 and 2 years
after the initial evaluation.
Some blood and spinal fluid samples from participants are stored for possible future studies
related to HIV research
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:
- MRI and MRS scan of the head: These tests use a magnetic field and radio waves to obtain
images of the brain and detect changes in certain brain chemicals that may be affected
by HIV infection. Both procedures are done at the same time. The patient lies on a table
that is moved into the scanner (a narrow cylinder), wearing earplugs to muffle loud
knocking and thumping sounds that occur during the scanning process. The procedure lasts
about 50 to 60 minutes, during which time the patient can communicate with the staff.
- Neuropsychological testing: Patients' thinking and behavior are evaluated with tests to
measure their memory, attention, language, problem-solving, academic, and motor skills
and questionnaires to assess behavioral and emotional functioning, quality of life, and
adherence to HIV medication. Parents are also asked to complete questionnaires assessing
their child's behavioral and emotional functioning, quality of life, important life
events, and adherence to HIV medication.
- Lumbar puncture (spinal tap): Cerebrospinal fluid (CSF) is collected for analysis. For
this procedure, a local anesthetic is given and a needle is inserted in the space
between the bones in the lower back where the CSF circulates below the spinal cord. Some
fluid is collected through the needle. Blood tests and a physical examination are done
before the procedure to make sure it can be done as safely as possible. Patients may
also be sedated to prevent any discomfort.
- Follow-up: The blood tests, MRI and MRS scans and spinal tap are repeated 1 and 2 years
after the initial evaluation.
Some blood and spinal fluid samples from participants are stored for possible future studies
related to HIV research
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.
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:
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
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
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