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
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
- 否
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
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
Giancarlo Ceccarelli
MD, PhD, MSc
University of Roma La Sapienza
