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临床试验/NCT01547754
NCT01547754终止不适用

Inflammation and Function of P-gp in HIV Infection of Brain

National Institute of Mental Health (NIMH)1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2012年1月9日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
8
试验地点
1
主要终点
Brain uptake of [11C]dLop after pharmacological challenge with the P-gp inhibitor tariquidar.

研究概览

简要总结

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.

详细描述

Objective:

To determine the relationship among neuroinflammation, Permeability-glycoprotein (P-gp) function and mild neurocognitive disorder (MND), a cognitive disorder associated with HIV infection.

Study Population:

HIV seropositive subjects with MND, HIV seropositive subjects with normal cognitive function, and HIV seronegative control subjects.

Design:

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Brain uptake of [11C]dLop after pharmacological challenge with the P-gp inhibitor tariquidar.

次要结局

  • Cerebrospinal fluid concentrations of antiretroviral drugs and inflammatory markers.

研究者

研究点 (1)

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