NCT03478540Unknown不适用
Impact of Gut Microbiota on the Immune Recovery in HIV-infection
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
- 否
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
Hongzhou Lu
Vice Director
Shanghai Public Health Clinical Center
研究点 (1)
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