NCT00904384已完成不适用
Prevalencia, Factores de Riesgo y características patogénicas Diferenciales de EPOC y Enfisema en Pacientes Con infección VIH.
Cimera1 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2008年7月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Prevalence of airflow obstruction compatible with COPD in patients with HIV infection
研究概览
简要总结
The prevalence of COPD in HIV+ and AIDS patients is unknown. The pathophysiology of HIV infection and COPD might be of interest to both conditions. The research hypotheses of this study are:
In patients with HIV infection living in the Autonomous Community of the Balearic Islands (CAIB):
- The Prevalence of airflow obstruction in patients with HIV infection is higher than in the general population.
- In these patients, the prevalence of emphysema detected by HRCT is common (greater than or equal to 15%)
- DLCO measurement is a good marker for the presence of emphysema on CT
- The inflammatory response is different from that seen in patients with COPD and / or emphysema without HIV infection
详细描述
Objectives
Main objective To determine the prevalence of COPD
Secondary objectives
- To determine the prevalence (and severity) of emphysema (HRCT)
- To Identify risk factors associated with the development of COPD and / or emphysema
- To analyze the predictive value of measuring DLCO as a marker of emphysema by HRCT
- To determine the prevalence of lung function abnormalities deeming specific drug treatment (bronchodilators, inhaled corticosteroids) in the absence of clinical symptoms
- To compare the pattern of inflammatory response in patients with COPD and / or emphysema, with and without HIV infection
Methodology:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 40 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV infection in stable phase (minimum of three months)
- •Being followed-up in external HUSD consultations (on a regular basis)
- •Age 40-69 years
排除标准
- •Chronic non-respiratory disease in terminal stage (stage IV or V of chronic kidney failure, heart failure, advanced chronic liver disease (Child C))
- •Lack of cooperation
- •Estimated survival of less than 1 year or Karnofsky <70
- •Pregnancy
- •Opportunistic infection in the last month
- •Post lung resection
- •Systemic treatment with corticosteroids, immunosuppressive chemotherapy or interferon at the time of inclusion
结局指标
主要结局
Prevalence of airflow obstruction compatible with COPD in patients with HIV infection
时间窗: cross-sectional
次要结局
- To determine the prevalence (and severity) of emphysema (HRCT)(Cross-sectional)
- To Identify risk factors associated with the development of COPD and / or emphysema(Cross-sectional)
- To analyze the predictive value of measuring DLCO as a marker of emphysema by HRCT(Cross-sectional)
- To determine the prevalence of lung function abnormalities deeming specific drug treatment (bronchodilators, inhaled corticosteroids) in the absence of clinical symptoms(Cross-sectional)
- To compare the pattern of inflammatory response in patients with COPD and / or emphysema, with and without HIV infection(Cross-sectional)
研究者
研究点 (1)
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