Prevalence and Determinants of Chronic Obstructive Pulmonary Disease (COPD) in HIV+ Patients (HIV&COPD)
Prevalencia, Factores de Riesgo y características patogénicas Diferenciales de EPOC y Enfisema en Pacientes Con infección VIH.
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
研究概览
详细说明
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:
Cross-sectional, descriptive, study of up to 350 patients with HIV infection.
All the patients will be be assessed with:
- an standardized clinical questionnaire
- full lung function tests
- high resolution CT scan
- induced sputum for bacterial culture, P. jiroveci, proinflamatory citokines (cytokines array)
- blood analysis: hemogram; basic biochemistry; HIV predictors; autoantibodies; proinflammatory citokines (ultrasensitive ELISA); C reactive protein (ultrasensitive nephelometry)
- exhaled gases (NO and CO)
Statistical analysis:
Description of the univariate distribution of the categorical or ordinal variables will be realized with a table of frequencies, and in quantitative variables by means of measures of central tendency (mean or median) and dispersion (standard deviation or 95 % confidence intervals). Depending on the normality of the distribution of variables, any comparisons will be assessed by means of parametric tests (T test; Chi2) or non parametric tests (Mann Whitney). To explore relationships between the variables of study, Kolgomorov-Smirnov for the comparison of groups and analysis of regression bivariate, and multivariate (logistic regression), will be conducted.
研究类型
注册 (预期的)
联系人和位置
学习地点
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Illes Balears
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Palma de Mallorca、Illes Balears、西班牙、07014
- Hospital Universitario Son Dureta
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- HIV infection in stable phase (minimum of three months)
- Being followed-up in external HUSD consultations (on a regular basis)
- Age 40-69 years
Exclusion Criteria:
- 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
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
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HIV+
Patients with HIV infection living in the Autonomous Community of the Balearic Islands (CAIB), Spain
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Reference group
Same determinations as in HIV+ cases will be obtained in the control group of COPD patients without HIV infection as part of the study PAC-EPOC (FIS 05/2082)
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Prevalence of airflow obstruction compatible with COPD in patients with HIV infection
大体时间:cross-sectional
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cross-sectional
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次要结果测量
结果测量 |
大体时间 |
---|---|
To determine the prevalence (and severity) of emphysema (HRCT)
大体时间:Cross-sectional
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Cross-sectional
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To Identify risk factors associated with the development of COPD and / or emphysema
大体时间:Cross-sectional
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Cross-sectional
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To analyze the predictive value of measuring DLCO as a marker of emphysema by HRCT
大体时间:Cross-sectional
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Cross-sectional
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To determine the prevalence of lung function abnormalities deeming specific drug treatment (bronchodilators, inhaled corticosteroids) in the absence of clinical symptoms
大体时间:Cross-sectional
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Cross-sectional
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To compare the pattern of inflammatory response in patients with COPD and / or emphysema, with and without HIV infection
大体时间:Cross-sectional
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Cross-sectional
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合作者和调查者
赞助
调查人员
- 首席研究员:Melchor Riera, MD、Hospital Universitario Son Dureta
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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