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临床试验/NCT04810858
NCT04810858招募中不适用

Modeling the Effects of Chronic Marijuana Use on Neuroinflammation and HIV-related Neuronal Injury

Wake Forest University Health Sciences2 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2021年8月18日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
220
试验地点
2
主要终点
Change in overall white matter integrity as measured by fractional anisotropy (FA)

研究概览

简要总结

This study applies a hypothesis-driven approach to examine the effects of chronic marijuana use on HIV-associated inflammation and its subsequent impacts on central nervous system function, with the goal of identifying the mechanisms through which cannabinoids modulate neurological disorders and other comorbidities in persons with HIV.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
25 Years 至 59 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • verified HIV status
  • Current marijuana use (MJ+ groups only)
  • No current marijuana use (MJ- groups only)
  • current engagement in HIV care (HIV+ participants only)
  • receipt of cART as first-line of treatment (HIV+ participants only)
  • stable cART regimen (HIV+ participants only)
  • undetectable HIV RNA viral load for >1 year (HIV+ participants only)

排除标准

  • Lifetime abuse for any illicit drug other than marijuana
  • <9th grade education; illiteracy or lack of fluency in English
  • history of moderate or severe head trauma
  • unstable or serious neurological disorders
  • severe mental illness
  • systemic autoimmune diseases
  • immunotherapy
  • MRI contraindications

结局指标

主要结局

Change in overall white matter integrity as measured by fractional anisotropy (FA)

时间窗: baseline, 1-year follow-up, and 2-year follow-up

FA will be measured using diffusion-weighted imaging. Higher FA is associated with higher overall white matter integrity. FA is a scalar value between 0 and 1.

Change in axonal damage was measured by neurofilament light (NfL) protein

时间窗: baseline, 1-year follow-up, and 2-year follow-up

NfL will be measured using blood serum and processed using an ultrasensitive immunoassay. Higher NfL is associated with more axonal damage. NfL protein units of measure are in picogram/milliliter\^-1.

Change in demyelination or dysmyelination as measured by radial diffusivity (RD)

时间窗: baseline, 1-year follow-up, and 2-year follow-up

RD will be measured using diffusion-weighted imaging. Higher radial diffusivity is associated with more demyelination and dysmyelination. The unit of measure for RD is micrometer\^2/millisecond.

Change in extracellular tissue edema as measured by non-restricted fraction (NF)

时间窗: baseline, 1-year follow-up, and 2-year follow-up

NF will be measured using diffusion-weighted imaging. Lower non-restricted fraction is associated with increased extracellular tissue edema. The unit of measure for NF is micrometer\^2/millisecond.

Change in white matter integrity as measured by white matter tract streamline count

时间窗: baseline, 1-year follow-up, and 2-year follow-up

White matter tract streamline count will be measured using diffusion-weighted imaging. Lower white matter tract streamline count is associated with lower white matter integrity. The unit of measure for white matter tract streamline count is the total number of streamlines within a white matter tract.

Change in neurocognitive function as measured by neuropsychological battery

时间窗: baseline, 1-year follow-up, and 2-year follow-up

The neuropsychological testing battery assesses 7 cognitive domains with 3-4 tests per domain. Raw scores from each test will be converted to demographically adjusted standard scores, called T-scores using up-to-date US normative data. A T-score of 50 is considered the normative mean, and each 10-point deviation is equivalent to 1 standard deviation. The minimum possible T-score is 0 and the maximum is 100, with higher scores meaning better neurocognitive function. The average T-score for all tests in a domain will be the domain T-score, and the average of all domain T-scores will be the global T-score. T-scores will serve as the primary continuous measure because they capture the full range of cognitive function.

Change in axonal loss and injury as measured by axonal diffusivity (AD)

时间窗: baseline, 1-year follow-up, and 2-year follow-up

AD will be measured using diffusion-weighted imaging. Lower axonal diffusivity is associated with more axonal loss and injury. The unit of measure for AD is micrometer\^2/millisecond.

Change in inflammation-related cellularity as measured by restricted fraction (RF)

时间窗: baseline, 1-year follow-up, and 2-year follow-up

RF will be measured using diffusion-weighted imaging. Higher restricted fraction is associated with higher inflammation-related cellularity. The unit of measure for RF is micrometer\^2/millisecond.

Change in gray matter as measured by cortical area and thickness and cortical and subcortical volume

时间窗: baseline, 1-year follow-up, and 2-year follow-up

Cortical areas and thickness and cortical and subcortical volume will be measured using T1-weighted imaging. Lower gray matter is associated with decreased cognitive function and is a marker of neurodegenerative disease. Cortical area, thickness, and volume units of measure are in millimeter\^2. Subcortical volume units of measure are in millimeter\^3.

Change in neuronal integrity as measured by N-acetyl aspartate (NAA)

时间窗: baseline, 1-year follow-up, and 2-year follow-up

NAA will be measured using Echo-planar spectroscopic imaging. Lower NAA is associated with less neuronal integrity. NAA units of measure is parts per million.

Change in neuronal-glial interaction as measured by Glutamate + glutamine (GLX)

时间窗: baseline, 1-year follow-up, and 2-year follow-up

GLX will be measured using Echo-planar spectroscopic imaging. Lower GLX is indicative of less neuronal-glial interactions. GLX units of measure is parts per million.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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