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临床试验/NCT00027040
NCT00027040已完成不适用

HIV-Associated Cognitive Impairment and Oxidative Stress: An In Vivo Proton Magnetic Resonance Spectroscopy Study of Cerebral Injury

National Institute of Allergy and Infectious Diseases (NIAID)22 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2001年11月19日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
22

研究概览

简要总结

The purpose of this study is to compare pictures of the brain of HIV-infected people with memory problems before and after treatment with selegiline. Selegiline is the study drug received through A5090.

HIV patients generally develop memory problems late in the disease. This will be examined using noninvasive proton magnetic resonance spectroscopy (1H-MRS). The effect of the drug selegiline on memory problems also will be examined.

详细描述

HIV-associated cognitive impairment generally develops during the later stages of the disease. This study proposes to non-invasively examine the pattern and extent of cerebral injury associated with HIV infection and its response to selegiline by using 1H-MRS. The following hypotheses will be tested: selegiline, a compound with antioxidant and anti-apoptotic properties, will reverse the metabolic abnormalities measured by 1H-MRS, and these changes will parallel the degree of improvement in cognitive and functional performance.

This is a substudy of ACTG A5090. The pattern and extent of cerebral injury associated with HIV infection and its response to selegiline are examined using a 1H-MRS. 1H-MRS evaluations are performed at screening and Week 24 (or at the time of premature discontinuation) of Step 1 of A5090. The screening MRS exams may only be performed once all A5090 screening evaluations (including the lumbar puncture) have been completed and it has been determined that the patient is eligible for A5090 study entry.

The screening MRS must be performed prior to A5090 study drug administration. The Week-24 MRS must be performed while the patient is still on blinded study drug.

研究设计

研究类型
Interventional
主要目的
Treatment

入排标准

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

入选标准

  • Patients may be eligible for this study if they:
  • Are enrolled in ACTG protocol A
  • Meet the inclusion/

排除标准

  • set forth for the Step 1 phase of AACTG protocol A
  • Exclusion Criteria
  • Patients will not be eligible for this study if they have:
  • Claustrophobia (unless sedation with lorazepam or zolpidem allows for safe performance of the MRS).
  • Metallic implants/medical devices (e.g., skull implants or cardiac devices).

研究者

申办方类型
Nih
责任方
Sponsor

研究点 (22)

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