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

HIV Infections Clinical Trial

— HIV&COPD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00904384
• Other study ID #: IB956/08 IP
• Status: Completed
• Phase: N/A
• First received: May 15, 2009
• Last updated: June 9, 2011
• Start date: July 2008
• Est. completion date: January 2011

Study information

• Verified date: June 2011
• Source: Cimera
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Conselleria de Salut i Consum
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 69 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• COPD
• HIV Infections
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
Spain	Hospital Universitario Son Dureta	Palma de Mallorca	Illes Balears

Sponsors (2)

Lead Sponsor	Collaborator
Cimera	Hospital Universitari Son Dureta

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of airflow obstruction compatible with COPD in patients with HIV infection		cross-sectional	No
Secondary	To determine the prevalence (and severity) of emphysema (HRCT)		Cross-sectional	No
Secondary	To Identify risk factors associated with the development of COPD and / or emphysema		Cross-sectional	No
Secondary	To analyze the predictive value of measuring DLCO as a marker of emphysema by HRCT		Cross-sectional	No
Secondary	To determine the prevalence of lung function abnormalities deeming specific drug treatment (bronchodilators, inhaled corticosteroids) in the absence of clinical symptoms		Cross-sectional	No
Secondary	To compare the pattern of inflammatory response in patients with COPD and / or emphysema, with and without HIV infection		Cross-sectional	No

External Links

•   CIMERA