ARTiBIOME: Effect of HIV and ART on Gut Microbiome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Beta diversity changes of fecal microbiota composition
研究概览
简要总结
Antiretroviral treatment for HIV has allowed patients to have undetectable viral load indefinitely. Despite that, HIV infection has become a chronic inflammatory disease, with increased mortality. This pro-inflammatory state is in part explained by the dysbiosis of intestinal bacterial populations. However, little is known on the impact of the antiretroviral treatment on this population and very few studies have evaluated these alterations.
The aim of this study is to study microbiome on healthy patients and HIV-infected patients exposed to antiretroviral treatment with integrase strand transfer inhibitors.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
MSM HIV-infected on ART with >500 CD4 Tcells
Men who have sex with men with HIV infection, on ART and with >500 CD4 T cells/uL
干预措施: Integrase strand transfer inhibitors (Drug)
MSM HIV-infected starting ART
Men who have sex with men with HIV infection, starting ART
干预措施: Integrase strand transfer inhibitors (Drug)
MSM HIV-infected on ART with <350 CD4 Tcells
Men who have sex with men with HIV infection, on ART and with <350 CD4 T cells/uL
干预措施: Integrase strand transfer inhibitors (Drug)
MSM HIV negative patients starting PEP with INST
Men who have sex with men without HIV infection, starting post-exposure prophylaxis with raltegravir
干预措施: Integrase strand transfer inhibitors (Drug)
结局指标
主要结局
Beta diversity changes of fecal microbiota composition
时间窗: Baseline and 1 month, 3 months, 12 months
Beta diversity changes of fecal microbiota composition between study groups
Alpha diversity changes of fecal microbiota composition
时间窗: Baseline and 1 month, 3 months, 12 months
Alpha diversity changes of fecal microbiota composition between study groups
次要结局
未报告次要终点