HIV Infections Clinical Trial
Official title:
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):
1. The Prevalence of airflow obstruction in patients with HIV infection is higher than in
the general population.
2. In these patients, the prevalence of emphysema detected by HRCT is common (greater than
or equal to 15%)
3. DLCO measurement is a good marker for the presence of emphysema on CT
4. The inflammatory response is different from that seen in patients with COPD and / or
emphysema without HIV infection
Objectives
Main objective To determine the prevalence of COPD
Secondary objectives
1. To determine the prevalence (and severity) of emphysema (HRCT)
2. To Identify risk factors associated with the development of COPD and / or emphysema
3. To analyze the predictive value of measuring DLCO as a marker of emphysema by HRCT
4. To determine the prevalence of lung function abnormalities deeming specific drug
treatment (bronchodilators, inhaled corticosteroids) in the absence of clinical
symptoms
5. 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:
1. an standardized clinical questionnaire
2. full lung function tests
3. high resolution CT scan
4. induced sputum for bacterial culture, P. jiroveci, proinflamatory citokines (cytokines
array)
5. blood analysis: hemogram; basic biochemistry; HIV predictors; autoantibodies;
proinflammatory citokines (ultrasensitive ELISA); C reactive protein (ultrasensitive
nephelometry)
6. 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.
;
Observational Model: Case-Only, Time Perspective: Cross-Sectional
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