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NCT01547754 · ClinicalTrials.gov registry record
Mild Neurocognitive Disorder in HIV Infection of the Brain
A clinical trial, sponsored by National Institute of Mental Health (NIMH).
- Terminated
- Registry status
- 8
- Enrollment target
NCT01547754: Clinical Trial study, sponsored by National Institute of Mental Health (NIMH).
NCT01547754 is a clinical trial that was terminated before completion, run by National Institute of Mental Health (NIMH). The registered enrollment target is 8 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01547754 was terminated before completion, sponsored by National Institute of Mental Health (NIMH).
- TERMINATED
- Registry status
- 8 participants
- Enrollment target
Study Summary
Background: \- Some people with human immunodeficiency virus (HIV) develop problems with thinking and concentration when the virus affects the brain. This is known as mild neurocognitive disorder (MND). Research has shown that some HIV medications do not get through the blood brain barrier very well. P-glycoprotein (P-gp) is a brain protein that is part of the blood brain barrier. Differences in the activity of P-gp may help explain why some people with HIV develop MND. It is also possible that MND is partly due to inflammation in the brain. Researchers want to study P-gp and its effect on MND and HIV infection. Objectives: \- To study P-gp and brain inflammation related to HIV infection. Eligibility: * Individuals between 18 and 60 years of age who have HIV and either do or do not have MND. * Healthy volunteers between 18 and 60 years of age. Design: * Participants will be screened with a medical history and physical exam. Blood and urine samples will be collected. * Participants will have one outpatient visit and one 3-day inpatient stay. * At the outpatient visit, participants will provide blood samples and have a lumbar puncture (spinal tap). The spinal tap will collect cerebrospinal fluid for study. * At the inpatient visit, participants will have two positron emission tomography (PET) scans of the brain. These scans will study brain activity and possible inflammation. One scan will involve a study drug called tariquidar, which blocks the activity of P-gp. A second lumbar puncture will be done before the first PET scan. Blood and urine samples will be collected daily.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2012-01-09 |
| Est. Completion | 2014-08-25 |
Why NCT01547754 stopped before completion
NCT01547754 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 8 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01547754 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01547754 about?
NCT01547754 is a clinical study titled "Mild Neurocognitive Disorder in HIV Infection of the Brain". Background: \- Some people with human immunodeficiency virus (HIV) develop problems with thinking and concentration when the virus affects the brain. This is known as mild neurocognitive disorder (MND). Research has shown that some HIV medications do not get through the blood brain barrier very wel...
What is the current status of trial NCT01547754?
This trial is currently terminated. The enrollment target is 8 participants. The study started on 2012-01-09. Estimated completion is 2014-08-25.
Who is sponsoring clinical trial NCT01547754?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
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