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临床试验/NCT03478540
NCT03478540Unknown不适用

Impact of Gut Microbiota on the Immune Recovery in HIV-infection

Shanghai Public Health Clinical Center1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2017年12月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
入组人数
80
试验地点
1
主要终点
Immune recovery

研究概览

简要总结

To explore whether gut microbiota would impact CD4 T cells recovery in HIV-infected patients on antiretroviral therapy (ART). We prospectively enroll patients initiate ART and collect their fecal at followup for one year.

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 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Confirmed HIV infection
  • Antiretroviral therapy naive
  • CD4 T cell counts<350cells/mm3
  • Agree to participate

排除标准

  • Don't want to start antiretroviral therapy
  • Cocurrent cancer or opportunistic infection
  • Liver diseases
  • received antibiotics within four weeks of enrollment

结局指标

主要结局

Immune recovery

时间窗: 48 weeks

Cluster of differentiation 4 (CD4) T cells increased \>25% or to higher than 350 cells/mm3

次要结局

  • HIV viral load(48 weeks)
  • Microbiota composition(week 0 and 48)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Hongzhou Lu

Vice Director

Shanghai Public Health Clinical Center

研究点 (1)

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