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

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ClinicalTrials.gov Identifier: NCT00904384
Recruitment Status : Completed
First Posted : May 19, 2009
Last Update Posted : June 10, 2011
Sponsor:
Collaborator:
Hospital Universitari Son Dureta
Information provided by:
Cimera

Tracking Information
First Submitted Date May 15, 2009
First Posted Date May 19, 2009
Last Update Posted Date June 10, 2011
Study Start Date July 2008
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 18, 2009)
Prevalence of airflow obstruction compatible with COPD in patients with HIV infection [ Time Frame: cross-sectional ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT00904384 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: May 18, 2009)
  • To determine the prevalence (and severity) of emphysema (HRCT) [ Time Frame: Cross-sectional ]
  • To Identify risk factors associated with the development of COPD and / or emphysema [ Time Frame: Cross-sectional ]
  • To analyze the predictive value of measuring DLCO as a marker of emphysema by HRCT [ Time Frame: Cross-sectional ]
  • 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 ]
  • To compare the pattern of inflammatory response in patients with COPD and / or emphysema, with and without HIV infection [ Time Frame: Cross-sectional ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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.
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.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • HIV Infections
  • COPD
Intervention Not Provided
Study Groups/Cohorts
  • 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)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Estimated Enrollment
 (submitted: May 18, 2009)
350
Original Estimated Enrollment Same as current
Actual Study Completion Date January 2011
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 40 Years to 69 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT00904384
Other Study ID Numbers IB956/08 IP
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dr Melchor RIERA JAUME, Hospital Universitario Son Dureta
Study Sponsor Cimera
Collaborators Hospital Universitari Son Dureta
Investigators
Principal Investigator: Melchor Riera, MD Hospital Universitario Son Dureta
PRS Account Cimera
Verification Date June 2011