Immune Activation in HIV-1 Infected Patients Under AntiRetroviral Treatment: Etiologic Factors, Forms and Potential Association With Chronic Comorbidities Unrelated to Immune Deficiency.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Infection of novo persistent
研究概览
简要总结
Immune Activation persists in HIV-1 infected patients despite efficient antiretroviral treatment. This immune activation is responsible for immune deficiency as well as for non-AIDS related comorbidities, such as non-alcoholic Fatty liver disease, metabolic syndrome or osteoporosis. The goal of this observational transversal multicentric study is to establish the etiologic factors of persistent immune activation in treated HIV-1 infected patients (persistent de novo infection of T CD4+ cells, microbial translocation, active coinfections, immunosenescence, T CD4+ cells lymphopenia, Treg deficiency), its different forms ( activation of T CD4+ cells, T CD8+ cells, B cells, NK cells, monocytes, granulocytes, platelets, endothelial cells or general inflammation) and the potential correlation between causes, forms of immune activation and emergent comorbidities (kidney, bone or liver dysfunction, metabolic syndrome).
详细描述
Immune Activation persists in HIV-1 infected patients despite efficient antiretroviral treatment. This immune activation is responsible for immune deficiency as well as for non-AIDS related comorbidities, such as non-alcoholic Fatty liver disease, metabolic syndrome or osteoporosis. The goal of this observational transversal multicentric study is to establish the etiologic factors of persistent immune activation in treated HIV-1 infected patients (persistent de novo infection of T CD4+ cells, microbial translocation, active coinfections, immunosenescence, T CD4+ cells lymphopenia, Treg deficiency), its different forms ( activation of T CD4+ cells, T CD8+ cells, B cells, NK cells, monocytes, granulocytes, platelets, endothelial cells or general inflammation) and the potential correlation between causes, forms of immune activation and emergent comorbidities (kidney, bone or liver dysfunction, metabolic syndrome). These correlations could highlight physiopathologic mechanisms relating a specific cause of immune activation, activation of a specific subpopulation of immune cells and a comorbidity. Physiopathologic mechanisms could then be tested in vitro and lead into new therapeutic tracks of immune activation secondary to HIV-1 or to the natural ageing process.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age > or = 45 years
- •HIV-1 infection
- •Number of T CD4+ lymphocytes before antiretroviral treatment < 350 cells/mm3
- •Current number of T CD4+ lymphocytes > 200 cells / mm3 for 6 moths before inclusion
- •Efficient and well tolerated antiretroviral treatment for more than 24 months
- •HIV-1 viral load < 50 copies/ml for more than 24 months before inclusion
- •Patient able to understand the nature, the objective and the methods of the study
- •Patient having signed the informed consent
- •Affiliation to French Social Security System
排除标准
- •Patient having a current evidence of II to IV rank of the ANRS scale clinical condition
- •Patient having a current evidence of III to IV rank of the ANRS scale biological condition
- •Patient has a current evidence of an active coinfection
- •Patient has a current (active) diagnosis of acute hepatitis due to any cause. Patients with chronic hepatitis, including chronic hepatitis B and/or C, may enter the study as long as they have stable liver function tests and undetectable viral load of hepatitis B and/or C
- •Patient has a cirrhosis
- •Patient presents with a non infectious pathology that might give immune modifications
- •Patient using immuno-modulator therapy or chemotherapy
- •Patient is currently participating or has participated in a study (within the exclusion period defined by this study)
- •Patient is pregnant or breastfeeding
研究组 & 干预措施
Treated HIV-1 infected patients
Treated HIV-1 infected patients for Blood test
干预措施: Blood test (Biological)
No treated HIV-1 infected patients
No treated HIV-1 infected patients for Blood test
干预措施: Blood test (Biological)
Healthy witness
Healthy witness for Blood test
干预措施: Blood test (Biological)
结局指标
主要结局
Infection of novo persistent
时间窗: Infection of novo persistent the day of inclusion
Etiologic factors of persistent immune activation in treated HIV-1 infected patients (obstinacy of the infection of new cells T CD4 +, microbial translocation, active coinfection, immunosenescence, lymphopenia T CD4 +, deficit in lymphocytes Treg) on a day: the day of the inclusion
次要结局
- Microbial translocation(Microbial translocation the day of inclusion)
- Diagnosis immunizing activation(Diagnosis immunizing activation the day of inclusion)