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临床试验/NCT02164344
NCT02164344Unknown不适用

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

University of Roma La Sapienza4 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2013年1月1日最近更新:
适应症

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:

  1. to reduce microbial translocation induced inflammation in cART-treated individuals with supplementation of cART with the probiotics.
  2. 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

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

发起方
University of Roma La Sapienza
申办方类型
Other
责任方
Principal Investigator
主要研究者

Giancarlo Ceccarelli

MD, PhD, MSc

University of Roma La Sapienza

研究点 (4)

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