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临床试验/NCT01344642
NCT01344642已完成不适用

Qualitative and Quantitative HIV RNA Detection in Saliva Using the Oragene RNA Kit

Ottawa Hospital Research Institute1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2007年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1

研究概览

简要总结

The purpose of this study is to determine if the Oragene.RNA kit is able to detect HIV RNA in saliva.

详细描述

There is an important need for a rapid, non-invasive, sensitive and specific method for detection of HIV RNA, particularly in clinical settings in which patients at risk for HIV exposure are assessed and screened. A rapid and non-invasive method for quantitative testing of HIV RNA would be also valuable to monitor suppression of HIV RNA as a primary surrogate marker of combination antiretroviral therapy efficacy. An Ottawa-based biotech company (DNA Genotek Inc) has developed and sells to research and clinical labs world-wide a kit (Oragene� DNA Self-collection kit) that permits the collection, stabilization at room temperature, and purification of DNA present in saliva. They have recently developed a kit (Oragene��RNA) that is purported to stabilize RNA in saliva, a non-invasive source of a biological fluid.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Four groups of 10 patients each will be recruited:
  • Controls (HIV and HCV seronegative by previous testing)
  • HIV seropositive with HIV RNA >1000 copies/mL and not on combination antiretroviral therapy. No concurrent HCV infection.
  • HIV seropositive with HIV RNA <50 copies/mL as a consequence of combination antiretroviral therapy use. No concurrent HCV infection.
  • HIV seropositive with HIV RNA >1000 copies/mL and not on combination antiretroviral therapy. HCV RNA positive and not on antiviral therapy.

排除标准

  • Not fitting one of the 4 groups

研究者

申办方类型
Other

研究点 (1)

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