Clinical trial NCT00904384: Prevalence and Determinants of Chronic Obstructive Pulmonary Disease (COPD) in HIV+ Patients
Official title: Prevalencia, Factores de Riesgo y características patogénicas Diferenciales de EPOC y Enfisema en Pacientes Con infección VIH.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
COPD
Keywords: HIV+
COPD
emphysema
Lead sponsor: Cimera
Sponsor class: NETWORK
Collaborators: name: Hospital Universitari Son Dureta
First posted: 2009-05-19
Enrollment: 350
Sex: ALL
Minimum age (years): 40
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients will be recruited from the HIV outpatient consultation of the Internal Medicine Department of Hospital Universitario Son Dureta (HUSD), in Mallorca, Spain. The HUSD is the tertiary, reference hospital in the CAIB.

Brief summary: 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

Detailed description: 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 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

Primary outcomes:
measure: Prevalence of airflow obstruction compatible with COPD in patients with HIV infection
timeFrame: cross-sectional
Secondary outcomes:
measure: To determine the prevalence (and severity) of emphysema (HRCT)
timeFrame: Cross-sectional
measure: To Identify risk factors associated with the development of COPD and / or emphysema
timeFrame: Cross-sectional
measure: To analyze the predictive value of measuring DLCO as a marker of emphysema by HRCT
timeFrame: Cross-sectional
measure: To determine the prevalence of lung function abnormalities deeming specific drug treatment (bronchodilators, inhaled corticosteroids) in the absence of clinical symptoms
timeFrame: Cross-sectional
measure: To compare the pattern of inflammatory response in patients with COPD and / or emphysema, with and without HIV infection
timeFrame: Cross-sectional
Other outcomes:
Locations:
city: Palma de Mallorca
country: Spain
facility: Hospital Universitario Son Dureta
state: Illes Balears
Study officials:
affiliation: Hospital Universitario Son Dureta
name: Melchor Riera, MD
role: PRINCIPAL_INVESTIGATOR
References: