Altered Homing of T Lymphocytes to the Gut and Poor Immune Reconstitution of the Intestinal Mucosa in Treated HIV-infected Individuals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Immune status: Measure of the frequencies of Th1 in peripheral blood and gut mucosa.
研究概览
简要总结
The gut immune barrier is not fully restored in HIV-1-infected subjects despite they were receiving antiretroviral treatment. This leaky gut leads to microbial translocation from the gut lumen into the bloodstream that fuels deleterious systemic inflammation. The chemotaxis axes that allow T lymphocytes to migrate from the blood to the gut mucosa in order to reconstitute the mucosal immune barrier seems altered in treated HIV-1-infected subjects.This study aims at better understanding the mechanisms involved in this lack of mucosal immune restoration.
详细描述
Pathophysiological study in human subjects, comparative, national, multicentric and prospective. Peripheral blood and intestinal biopsies will be collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 是
入选标准
- •For HIV-1-infected subjects group :
- •Age at least 18-year old
- •HIV-1 infection
- •Receiving continuous cART for ≥ 12 months, started during the chronic phase
- •Plasma viral load ≤50 copies/mL for ≥ 6 months (one blip ≤200 copies/mL authorized)
- •Blood CD4+ T cells count ≥ 350 cells/mm3
- •Indication for upper and/or lower digestive endoscopy
- •Patient enrolled in or a beneficiary of a Social Security programme (State Medical Aid or AME is not a Social Security programme)
- •Written informed consent.
- •For uninfected control group :
- •Age at least 18-year old
- •Indication for upper and/or lower digestive endoscopy
- •Patient enrolled in or a beneficiary of a Social Security programme (State Medical Aid or AME is not a Social Security programme)
- •Written informed consent
排除标准
- •For HIV-1-infected subject group :
- •HIV-2 infection
- •Inflammatory bowel diseases (Crohn's disease, ulcerative colitis) ; coeliac disease
- •Platelets count <50 G/L or abnormal hemostasis tests
- •Decompensated cirrhosis
- •Past or current lymphoma
- •Involvement in an HIV-1 immunotherapeutic vaccine study
- •Pregnant or breastfeeding women
- •Subjects participating in a study excluding participating in another study
- •Vulnerability, such as an age under 18, tutorship, trusteeship, or subjects deprived of liberty by a legal or administrative decision.
- •For uninfected control group :
- •HIV-1 and 2 infection
- •Inflammatory bowel diseases (Crohn's disease, ulcerative colitis) ; coeliac disease
- •Platelets count <50 G/L or abnormal hemostasis tests
- •Decompensated cirrhosis
- •Past or current lymphoma
- •Pregnant or breastfeeding women
- •Subjects participating in a study excluding participating in another study
- •Vulnerability, such as an age under 18, tutorship, trusteeship, or subjects deprived of liberty by a legal or administrative decision
研究组 & 干预措施
HIV-1 infected subjects
40 subjects will be recruited in the Department of Infectious Diseases of Toulouse University Hospital, France:
- 15 subjects will have an upper endoscopy (gastroscopy) with duodenal sampling
- 15 subjects will have a lower endoscopy (coloscopy) with colonic and ileal sampling
- 10 subjects will have both a gastroscopy and a coloscopy
干预措施: Peripheral blood and intestinal biopsies will be collected (Other)
Uninfected-controls
40 subjects will be recruited in the Department of Internal Medicine of Toulouse University Hospital, France:
- 10 subjects will have an upper endoscopy (gastroscopy) with duodenal sampling
- 10 subjects will have a lower endoscopy (coloscopy) with colonic and ileal sampling
- 20 subjects will have both a gastroscopy and a coloscopy
干预措施: Peripheral blood and intestinal biopsies will be collected (Other)
结局指标
主要结局
Immune status: Measure of the frequencies of Th1 in peripheral blood and gut mucosa.
时间窗: Baseline
The frequencies of Th1 will be measured by flow cytometry.
Immune status: Measure of the frequencies of Th17 in peripheral blood and gut mucosa.
时间窗: Baseline
The frequencies of Th17 will be measured by flow cytometry.
Immune status: Measure of the frequencies of Th22 in peripheral blood and gut mucosa.
时间窗: Baseline
The frequencies of Th22 will be measured by flow cytometry.
次要结局
- Microbial translocation : Quantification of soluble CD14 in plasma.(Baseline)
- Immune status: Quantification of cytokines in blood and gut mucosa.(Baseline)
- Immune status: Quantification of chemiokines in blood and gut mucosa.(Baseline)
- Microbial translocation : Quantification of soluble soluble CD163 in plasma.(Baseline)
- Microbial translocation : Quantification of 16S RNA.(Baseline)
- Microbial translocation : Quantification of Intestinal-type Fatty Acid-Binding Protein (I-FABP) in plasma.(Baseline)
- Microbial translocation : Quantification of Lipopolysaccharide Binding Protein (LBP).(Baseline)