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Completed

NCT Number: NCT00904384

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

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Prevalence of airflow obstruction compatible with COPD in patients with HIV infection

    Time frame: cross-sectional

Secondary outcomes

  1. To determine the prevalence (and severity) of emphysema (HRCT)

    Time frame: Cross-sectional

  2. To Identify risk factors associated with the development of COPD and / or emphysema

    Time frame: Cross-sectional

  3. To analyze the predictive value of measuring DLCO as a marker of emphysema by HRCT

    Time frame: Cross-sectional

  4. To determine the prevalence of lung function abnormalities deeming specific drug treatment (bronchodilators, inhaled corticosteroids) in the absence of clinical symptoms

    Time frame: Cross-sectional

  5. To compare the pattern of inflammatory response in patients with COPD and / or emphysema, with and without HIV infection

    Time frame: Cross-sectional

Sponsors and collaborators

Lead sponsor

Cimera

Network

Collaborators

  • Hospital Universitari Son Dureta

Registry information

Official study title

Prevalencia, Factores de Riesgo y características patogénicas Diferenciales de EPOC y Enfisema en Pacientes Con infección VIH.

Acronym: HIV&COPD

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
May 19, 2009
Registry last updated
Jun 10, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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