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临床试验/NCT02097381
NCT02097381Unknown不适用

HIV Infection and Gut Mucosal Immune Function: Longitudinal Analyses of Intestinal CD4+ and Th17 T Cells in HIV-infected Individuals on Short-term Antiretroviral Therapy

University of Roma La Sapienza1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2010年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
10
试验地点
1
主要终点
Difference of number of total Th1 and Th17 CD4+ T-cells (cell/mmc and %) in colon samples between T0 (before start of cARV) and T1 (after 6 months of cARV)

研究概览

简要总结

HIV infection is associated with a state of chronic, generalized immune activation that has been shown in many studies to be a key predictor of progression to AIDS. The molecular, cellular, and pathophysiological mechanisms underlying the HIV-associated immune activation are complex and still poorly studied. There is, however, growing consensus that both viral and host factors contribute to this phenotype, with emphasis on the role played by the mucosal immune dysfunction (and consequent microbial translocation). Moreover if it is known that in HIV-infected individuals, a severe depletion of intestinal cluster of differentiation 4 (CD4+) T-cells, is associated with loss of epithelium integrity, microbial translocation and systemic immune activation, the kinetics of intestinal CD4+ T-cell reconstitution under combined antiretroviral therapy (cART) remains poorly understood.

This study sought to evaluate the reconstitution of intestinal CD4+ T-cells, including Th1 and Th17, in blood and colon samples collected from HIV-infected individuals before and after a short term cART.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • naïve for antiretroviral treatment
  • met the criteria to start cART according to International Guidelines
  • written informed consent signed

排除标准

  • treatment with glucocorticosteroids and any immune modulating medication for more than seven days in the previous month
  • any past or current systemic malignancy, history of inflammatory diseases of the small or large intestine
  • pregnancy
  • anemia, use of anticoagulants, and any contraindications to phlebotomy or colonoscopy.

研究组 & 干预措施

naïve for cART that met the criteria to start treatment

Other

patients naïve for antiretroviral treatment that met the criteria to start cART according to International Guidelines.

These patients will be studied for primary and secondary outcomes after a short term antiretroviral therapy.

干预措施: Tenofovir-Emtricitabine plus Lopinavir/Ritonavir or Darunavir/Ritonavir (Drug)

结局指标

主要结局

Difference of number of total Th1 and Th17 CD4+ T-cells (cell/mmc and %) in colon samples between T0 (before start of cARV) and T1 (after 6 months of cARV)

时间窗: 6 months

recovery of total Th1 and Th17 CD4+ T-cells (cell/mmc and %) in gut mucosa after 6 months of cARV)

次要结局

  • Difference of number of total Th1 and Th17 CD4+ T-cells (cell/mmc and %) in blood samples between T0 (before start of cARV) and T1 (after 6 months of cARV)(6 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 (1)

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