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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 is a clinical trial that was terminated before completion, run by National Institute of Mental Health (NIMH). The registered enrollment target is 8 participants.

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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

FieldValue
Enrollment Target 8 participants
Start Date 2012-01-09
Est. Completion 2014-08-25

What the Registry Record Tells You About NCT01547754

The ClinicalTrials.gov registry entry for NCT01547754 describes a study currently listed as terminated, categorized as an unspecified phase. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Mental Health (NIMH), which has 343 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 0 interventions.

NCT01547754 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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