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Prevalence and Determinants of Chronic Obstructive Pulmonary Disease (COPD) in HIV+ Patients

This study is currenly Recruiting patients.
Sponsored by: Cimera

Purpose
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
Study Type: Treatment
Condition Treatment Phase
HIV Infections
COPD
None N/A
Study Design:Observational Model: Case-Only, Time Perspective: Cross-Sectional
Official Title: Prevalencia, Factores de Riesgo y características patogénicas Diferenciales de EPOC y Enfisema en Pacientes Con infección VIH.
Further Study Details:
Expected Total Enrollment:
Study Dates:July 2008 -
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.

Eligibility
Ages Eligible for Study- Min: 40 Years Max: 69 Years
Gender: Both
Criteria

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

  • Location and Contact Information
    Please refer to this study by ClinicalTrials.gov identifier: NCT00904384
    Illes Balears
    Hospital Universitario Son Dureta - Palma de Mallorca, Illes Balears 07014
    Gloria Samperiz, MD +34 971175000 gsamperiz@hsd.es

    More Information
    Record Last Reviewed:May 2009
    Last Updated:May 18, 2009
    Record First Recieved:May 15, 2009
    ClinicalTrials.gov Identifier:NCT00904384
    Health Authority: United States Food and Drug Administration
    Information obtained from ClinicalTrials.gov on September 02, 2010

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