Effects of Probiotics on Microbial Translocation and Immune Activation Markers in HIV-positive Patients on Combined Antiretroviral Therapy and Non-virological Study of the Effects of Therapy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Delta of Cluster of Differentiation 4 (CD4)+/Cluster of Differentiation 38 (CD38)-/Human Leukocyte Antigen-D related (HLA-DR+)
研究概览
简要总结
Combined antiretroviral therapy (cART)-treated patients have increased mortality and morbidity compared to age-matched seronegative individuals. This increased mortality and morbidity has been associated to immune activation that persists also in patients under cART even with undetectable levels of HIV-RNA in blood. Indeed, HIV-infected patients, irrespective of cART treatment, show higher levels of activated T cells, inflammatory monocytes and proinflammatory cytokines than seronegative individuals. Several putative causes of this residual inflammation have been proposed and include ongoing HIV replication at low levels, the presence of coinfections such as cytomegalovirus, and microbial translocation.
None of these causes are mutually exclusive and understanding the degree to which of these three cause residual inflammation in cART-treated individuals will require novel therapeutic interventions aimed at alleviated each putative cause.
In this longitudinal study we aim:
- to reduce microbial translocation induced inflammation in cART-treated individuals with supplementation of cART with the probiotics.
- to investigate the potential benefits of 24 weeks of probiotics supplementation on immune function and on immune activation status
Indeed, the early stage of HIV infection is associated with dysbiosis of the GI tract microbiome with reducted levels of bifidobacteria and lactobacillus species with increased levels of potentially pathogenic proteobacteria species.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •HIV positive patients
- •HIV viral load < 50 copies/ml
- •antiretroviral therapy from at least 2 years
排除标准
- •intestinal diseases
- •opportunistic diseases
- •pregnancy
结局指标
主要结局
Delta of Cluster of Differentiation 4 (CD4)+/Cluster of Differentiation 38 (CD38)-/Human Leukocyte Antigen-D related (HLA-DR+)
时间窗: 3 months
Delta of CD4+/CD38-/HLA-DR+ in blood (T0-T1)
次要结局
- Delta of Cluster of Differentiation 8 (CD8)+/CD38+/HLA-DR+(3 months)
- CD4 recovery (ΔCD4)(3 months)
研究者
Giancarlo Ceccarelli
MD, PhD, MSc
University of Roma La Sapienza
