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NCT00110331 · ClinicalTrials.gov registry record
Central Nervous System Disease in HIV-infected Children on HAART
A clinical trial of HIV Infections and Central Nervous System Diseases, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- 21
- Enrollment target
- 1
- Study location
NCT00110331: Completed study of HIV Infections and Central Nervous System Diseases, sponsored by National Cancer Institute (NCI).
NCT00110331 is a study of HIV Infections and Central Nervous System Diseases that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 21 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00110331, a study of HIV Infections and Central Nervous System Diseases, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- 21 participants
- Enrollment target
- 1
- Study location
Study 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-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 coll
Conditions Studied
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2005-05-03 |
| Est. Completion | 2014-09-09 |
What the finished NCT00110331 record still lists
NCT00110331 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (95% lower).
The record links to 2 conditions, with HIV Infections appearing as the primary indexed condition, and to 0 interventions.
NCT00110331 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00110331 about?
NCT00110331 is a clinical study titled "Central Nervous System Disease in HIV-infected Children on HAART". 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 de...
What is the current status of trial NCT00110331?
This trial is currently completed. The enrollment target is 21 participants. The study started on 2005-05-03. Estimated completion is 2014-09-09.
What conditions does trial NCT00110331 study?
This clinical trial studies the following conditions: HIV Infections, Central Nervous System Diseases.
Who is sponsoring clinical trial NCT00110331?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00110331 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00110331's enrollment target sits among peer trials
21 482nd of 542 higher than 57 of 542 other HIV Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infections trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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