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

NCT ID: NCT00904384

Last Updated: 2011-06-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 350 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2011-01-31

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.

Conditions

HIV Infections; COPD

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

HIV+

Patients with HIV infection living in the Autonomous Community of the Balearic Islands (CAIB), Spain

No interventions assigned to this group

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)

No interventions assigned to this group

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitari Son Dureta

OTHER

Sponsor Role: collaborator

Cimera

NETWORK

Sponsor Role: lead

Responsible Party

Hospital Universitario Son Dureta

Principal Investigators

Melchor Riera, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Son Dureta

Locations

Hospital Universitario Son Dureta

Palma de Mallorca, Balearic Islands, Spain

Countries

Spain

Related Links

http://www.hsd.es

Hospital Universitario Son Dureta

Other Identifiers

IB956/08 IP

Identifier Type: -

Identifier Source: org_study_id