Micro RNA as Prediction and/or Prognostic Markers of IRIS in TB-HIV Co-infected Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- miRNA expression profile in a cohort of patients with a HIV infection and Tuberculosis and correlate it with their clinical evolution
研究概览
简要总结
The role of miRNAs in HIV disease is yet to be completely defined. Host miRNAs target certain HIV genes, thus can affect HIV replication and participate in viral control. miRNAs can also block HIV production through disruption of Gag assembly on cell membranes. miRNA expression can characterize HIV disease phenotype, as has been shown in HIV elite controllers who have a well-defined miRNA expression profile. However, the studies of miRNA in acute infection and co-infections like tuberculosis are lacking. The investigators showed that during immune reconstitution syndrome (IRIS) in HIV/TB coinfected patients, innate immune response play a role as through NK cell degranulation, therefore testing for this could be used as a predictive marker of IRIS.
One of the limitations of miRNA detection is the technique, which is time-consuming, and needs laboratories that are specialized and equipped for molecular biology techniques. In contrast, flow cytometry has been developed in routine labs and has well-standardized techniques. For the routine detection of miRNA, flow cytometry could be the best way to perform high throughput screening for clinical applications.
Flow cytometry is a simple and effective way to evaluate miRNAs expression. In this project the investigators propose to evaluate, using flow cytometry, whether circulating miRNA pattern might be applicable as potential biomarkers in prediction and prognosis of IRIS in HIV/TB co-infected patients. The investigators propose to study the miRNA expression profile in a cohort of patients with a HIV infection and Tuberculosis and correlate it with their clinical evolution. As controls, the investigators propose to analyze expression of miRNAs in healthy controls as well as TB and HIV mono-infected patients.
AIMS OF THE PROPOSAL
- Identify miRNA expression profile as potential novel predictive and prognostic biomarkers for IRIS.
- Identify the miRNA expression profile in HIV patients, in TB patients and in HIV/TB co-infected patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •cf the CAMELIA clinical trial (NCT00226434)
- •For HIV+/TB- participants:
- •Inclusion Criteria
- •Age ≥ 18 years
- •CD4 cell count ≤ 200 x 106 cells/l
- •No evidence of tuberculosis infection.
- •Exclusion Criteria:
- •Age <18 years
- •Pregnancy or breastfeeding
- •CD4 cell count > 200 x 106 cells/l
- •Evidence of tuberculosis infection
- •Non ART naive at inclusion
- •For HIV-/TB+ participants:
- •Inclusion Criteria
- •Age ≥ 18 years
- •Confirmed tuberculosis infection.
- •Exclusion Criteria:
- •Age <18 years
- •Pregnancy or breastfeeding
- •AFB negative or MTB/RIF negative for MTB,
- •History of TB infection
- •For HIV-/TB- participants:
- •Inclusion Criteria
- •Age ≥ 18 years
- •No evidence of tuberculosis infection.
- •Exclusion Criteria:
- •Age <18 years
- •Pregnancy or breastfeeding
- •Evidence of tuberculosis infection
结局指标
主要结局
miRNA expression profile in a cohort of patients with a HIV infection and Tuberculosis and correlate it with their clinical evolution
时间窗: March 1st 2018 - March 1st 2020
Evaluate, using flow cytometry, whether circulating miRNA (in plasma and/or exosomes) pattern might be applicable as potential biomarkers in prediction and prognosis of IRIS in HIV/TB co-infected patients. Description of miRNA expression profile in a cohort of patients with a HIV infection and Tuberculosis and correlate it with their clinical evolution.
次要结局
未报告次要终点