5 Years Follow-up Evaluation of Deterioration Kidney Biomarkers of HIV Patients : HIVOL 2 Study.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 173
- 试验地点
- 2
- 主要终点
- Stage of chronic kidney disease (according to the Glomerular Filtration Rate)
研究概览
简要总结
The aim of this study is to compare the biomarkers levels as IL-18, KIM-1 and Cystatin C for patients infected by HIV with failure in renal function at year 5. The main criterion will be a degradation of the glomerular filtration throughput measured. It will be compared to clinical scores of degradation risks of renal function for patients infected with HIV.
详细描述
The aim of this study is to compare the biomarkers levels as IL-18, KIM-1 and Cystatin C for patients infected by HIV with failure in renal function at year 5. The main criterion will be a degradation of the glomerular filtration throughput measured. It will be compared to clinical scores of degradation risks of renal function for patients infected with HIV.
From 2011 to 2013, researchers realized a study called HIVOL, on the diagnostic performance of GFR (Glomerular Filtration Rate) estimators in patients infected with HIV. It lead to a publication in AIDS, retaken in the rational of recommendations of Infectious Diseases Society of America for the Chronic Renal Diseases support for patients infected with HIV.
235 patients were involved, for everyone researchers have a GFR measure (by Iohexol plasmatic clearance) and urinary and plasma samples.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Patient affiliated or entitled to a social security scheme
- •Patient HIV infected
- •Patient included in the HIVOL cohort with a GFR measure available
- •Patients who have given their consent in writing
排除标准
- •Pregnant or lactating women
- •Patients treated with metformin
- •Patients with a known allergy, regardless the type of allergy
- •Patients with a history of thyroid dysfunction
- •Any biological anomaly in the selection, which in the opinion of the investigator, may indicate a contraindication to the patient's participation in this study
- •Degradation recent (not older than three months) of renal function defined as the degradation of more than 25 % GFR.
- •Estimated GFR of less than 15 mL / min / 1.73m2
- •History of major immediate or delayed skin reaction known to the injection of iodinated contrast medium (OMNIPAQUE®)
- •Manifest thyrotoxicosis
- •Hypersensitivity to the active substance or to any of the excipients (OMNIPAQUE®)
- •Patient who expressed his refusal to participate in the study
- •Patient justice under protection
结局指标
主要结局
Stage of chronic kidney disease (according to the Glomerular Filtration Rate)
时间窗: Day 1
The aim of this study is to compare the level of biological biomarkers as microalbuminuria, proteinuria, KIM-1, IL-18, and Cystatin C with the level of this markers 5 years ago, for the HIVOL study performed between 2011 and 2013. These levels will allow the researchers to have an idea concerning the renal function of the patients followed.
次要结局
未报告次要终点