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

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

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 Overview

• Status: Completed
• Conditions: HIV Infections; COPD

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.

• Study Type: Observational
• Enrollment (Anticipated): 350

Contacts and Locations

Study Locations

• Spain
  • Illes Balears
    • Palma de Mallorca, Illes Balears, Spain, 07014
      • Hospital Universitario Son Dureta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
HIV+; Patients with HIV infection living in the Autonomous Community of the Balearic Islands (CAIB), Spain
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Prevalence of airflow obstruction compatible with COPD in patients with HIV infection	cross-sectional

Secondary Outcome Measures

Outcome Measure	Time Frame
To determine the prevalence (and severity) of emphysema (HRCT)	Cross-sectional
To Identify risk factors associated with the development of COPD and / or emphysema	Cross-sectional
To analyze the predictive value of measuring DLCO as a marker of emphysema by HRCT	Cross-sectional
To determine the prevalence of lung function abnormalities deeming specific drug treatment (bronchodilators, inhaled corticosteroids) in the absence of clinical symptoms	Cross-sectional
To compare the pattern of inflammatory response in patients with COPD and / or emphysema, with and without HIV infection	Cross-sectional

Collaborators and Investigators

• Sponsor: Cimera
• Collaborators: Hospital Universitari Son Dureta
• Investigators: Principal Investigator: Melchor Riera, MD, Hospital Universitario Son Dureta

Publications and helpful links

Helpful Links

• Hospital Universitario Son Dureta

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: May 15, 2009
• First Submitted That Met QC Criteria: May 18, 2009
• First Posted (Estimate): May 19, 2009

Study Record Updates

• Last Update Posted (Estimate): June 10, 2011
• Last Update Submitted That Met QC Criteria: June 9, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: COPD; emphysema; HIV+
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: IB956/08 IP