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临床试验/NCT02555930
NCT02555930已完成不适用

Clinical Phenotyping and Genotyping of HIV-Associated Sensory Neuropathy: The HIV-POGO Study

Imperial College London1 个研究点 分布在 1 个国家目标入组 148 人开始时间: 2014年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
148
试验地点
1
主要终点
Neuropathic Element of Pain Using the Doleur Neuropathique 4 Interview

研究概览

简要总结

This study aims to recruit a cohort of HIV patients with and without HIV-SN and to identify genetic risk factors for the development of HIV-SN and neuropathic pain. It also aims to more deeply phenotype the condition, using well validated questionnaires, and to identify any influence that early neurocognitive dysfunction may have on the reporting, diagnosis and treatment of neuropathic pain in the HIV population.

详细描述

HIV associated sensory neuropathy (HIV-SN) is a frequent complication of HIV infection, affecting between 20 and 57% of infected individuals. The advent of better antiretroviral treatment for HIV has meant that mortality from HIV has decreased dramatically in the UK. This means however, that chronic, age-related conditions associated with HIV, such as HIV-SN and cognitive impairment, are increasing in prevalence and becoming a significant disease burden.

The classification, diagnosis and treatment of HIV-SN remains poor. Currently, little is known about the genetic basis of the disorder and what risk factors mean that some patients with HIV develop neuropathy and pain, whilst others do not. It is hoped that by further characterising or 'phenotyping' the disorder, it will be easier to identify which patients are at risk of developing neuropathy and chronic pain. It may also mean that treatment can be more individualised as currently patients often undergo a frustrating 'trial and error' protocol of treatment, as clinicians can not yet predict who will respond to which treatment.

It has also been suggested that there is a link between HIV-SN and HIV associated neurocognitive disorder (HAND), which is another common, age-related complication of HIV infection. It may be that the existence of one pathology could predict the development of the other, or that the presence of HAND may impair the diagnosis or treatment of chronic pain associated with HIV-SN.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

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

  • Aged 18 years or over
  • HIV infection

排除标准

  • co-incident severe neurological disease
  • co-incident severe psychiatric illness
  • limited english language skills so as not able to conduct quantitative sensory testing
  • pregnancy
  • pain of greater than 3/10 on an NRS due to pathology other than HIV-SN

结局指标

主要结局

Neuropathic Element of Pain Using the Doleur Neuropathique 4 Interview

时间窗: Day 1

Doleur Neuropathique 4 Interview score greater than or equal to 4, indicating a high likelihood of neuropathic pain

次要结局

  • Conditioned Pain Modulation Efficiency(Day 1)
  • Cognitive Function: Global T-score for Cogstate Computerised Cognitive Function Test Set(Day 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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