Prevalence of Cerebral Small Vessels Disease (CSVD) Among Patients Infected With HIV-1
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 655
- 试验地点
- 1
- 主要终点
- Cerebral small vessel disease
研究概览
简要总结
Cerebral small vessel disease (CSVD) is a major cause of cognitive impairment and disability in the general population, secondary to the accumulation of asymptomatic elementary lesions. CSVD is directly correlated with age and cardiovascular risk factors and therefore would be challenging in term of public health care in the future. While HIV patients share the same cardiovascular risk factors and they are often diagnosed with cognitive impairment and frailty, CSVD has not been yet described in this population.
The global aim is to compare the prevalence of CSVD in a well controlled HIV+ population compared to HIV- controls matched with age and sex.
500 HIV+ patients and 250 age- and sex- matched controls will undergo a screening of the CSVD with a 10 minutes MRI (FLAIR and T2*).
Prevalence of the CSVD will be compared between HIV+ patients and controls. General and HIV-specific parameters from their electronic medical records will be compared between HIV+/CSVD+ and HIV+/CSVD- patients.
We are expecting to prove that CSVD is more frequent in HIV+ population.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age over 50
- •chronic HIV seropositive patient infected for at least 5 years
- •treated with any antiretroviral (ARV) therapy
- •plasmatic HIV viral load <40 copies/ml for at least one year with one authorized blip < 1000 copies/ml per year
排除标准
- •co-infection with hepatitis C virus (HCV)
- •uncontrolled high blood pressure (WHO criteria)
- •Personal history of cerebral infarction or cerebral ischemia
- •Personal history of neurological complication of the HIV-infection
- •Use of illegal drugs (except cannabis or poppers)
- •Glomerular filtration rate < 15 mL/mn
- •Complicated diabetes mellitus (glomerular filtration rate < 60ml/mn and/or proteinuria> 300 mg and/or retinopathy)
结局指标
主要结局
Cerebral small vessel disease
时间窗: baseline
Cerebral small vessel disease detected with MRI
次要结局
未报告次要终点