Trial record 19 of 34 for:    " May 13, 2009":" June 12, 2009"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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

This study has been completed.
Sponsor:
Collaborator:
Hospital Universitari Son Dureta
Information provided by:
Cimera
ClinicalTrials.gov Identifier:
NCT00904384
First received: May 15, 2009
Last updated: June 9, 2011
Last verified: June 2011
  Purpose

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

Condition
HIV Infections
COPD

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Prevalencia, Factores de Riesgo y características patogénicas Diferenciales de EPOC y Enfisema en Pacientes Con infección VIH.

Resource links provided by NLM:


Further study details as provided by Cimera:

Primary Outcome Measures:
  • Prevalence of airflow obstruction compatible with COPD in patients with HIV infection [ Time Frame: cross-sectional ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the prevalence (and severity) of emphysema (HRCT) [ Time Frame: Cross-sectional ] [ Designated as safety issue: No ]
  • To Identify risk factors associated with the development of COPD and / or emphysema [ Time Frame: Cross-sectional ] [ Designated as safety issue: No ]
  • To analyze the predictive value of measuring DLCO as a marker of emphysema by HRCT [ Time Frame: Cross-sectional ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To compare the pattern of inflammatory response in patients with COPD and / or emphysema, with and without HIV infection [ Time Frame: Cross-sectional ] [ Designated as safety issue: No ]

Estimated Enrollment: 350
Study Start Date: July 2008
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
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)

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

Ages Eligible for Study:   40 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00904384

Locations
Spain
Hospital Universitario Son Dureta
Palma de Mallorca, Illes Balears, Spain, 07014
Sponsors and Collaborators
Cimera
Hospital Universitari Son Dureta
Investigators
Principal Investigator: Melchor Riera, MD Hospital Universitario Son Dureta
  More Information

Additional Information:
CIMERA  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Dr Melchor RIERA JAUME, Hospital Universitario Son Dureta
ClinicalTrials.gov Identifier: NCT00904384     History of Changes
Other Study ID Numbers: IB956/08 IP
Study First Received: May 15, 2009
Last Updated: June 9, 2011
Health Authority: Spain: Conselleria de Salut i Consum

Keywords provided by Cimera:
HIV+
COPD
emphysema

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on September 16, 2014