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- Klinische proef NCT00904384
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):
- The Prevalence of airflow obstruction in patients with HIV infection is higher than in the general population.
- In these patients, the prevalence of emphysema detected by HRCT is common (greater than or equal to 15%)
- DLCO measurement is a good marker for the presence of emphysema on CT
- The inflammatory response is different from that seen in patients with COPD and / or emphysema without HIV infection
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
Objectives
Main objective To determine the prevalence of COPD
Secondary objectives
- To determine the prevalence (and severity) of emphysema (HRCT)
- To Identify risk factors associated with the development of COPD and / or emphysema
- To analyze the predictive value of measuring DLCO as a marker of emphysema by HRCT
- To determine the prevalence of lung function abnormalities deeming specific drug treatment (bronchodilators, inhaled corticosteroids) in the absence of clinical symptoms
- 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:
- an standardized clinical questionnaire
- full lung function tests
- high resolution CT scan
- induced sputum for bacterial culture, P. jiroveci, proinflamatory citokines (cytokines array)
- blood analysis: hemogram; basic biochemistry; HIV predictors; autoantibodies; proinflammatory citokines (ultrasensitive ELISA); C reactive protein (ultrasensitive nephelometry)
- 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.
Studietype
Inschrijving (Verwacht)
Contacten en locaties
Studie Locaties
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Illes Balears
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Palma de Mallorca, Illes Balears, Spanje, 07014
- Hospital Universitario Son Dureta
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
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HIV+
Patients with HIV infection living in the Autonomous Community of the Balearic Islands (CAIB), Spain
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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)
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Prevalence of airflow obstruction compatible with COPD in patients with HIV infection
Tijdsspanne: cross-sectional
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cross-sectional
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
To determine the prevalence (and severity) of emphysema (HRCT)
Tijdsspanne: Cross-sectional
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Cross-sectional
|
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To Identify risk factors associated with the development of COPD and / or emphysema
Tijdsspanne: Cross-sectional
|
Cross-sectional
|
|
To analyze the predictive value of measuring DLCO as a marker of emphysema by HRCT
Tijdsspanne: Cross-sectional
|
Cross-sectional
|
|
To determine the prevalence of lung function abnormalities deeming specific drug treatment (bronchodilators, inhaled corticosteroids) in the absence of clinical symptoms
Tijdsspanne: Cross-sectional
|
Cross-sectional
|
|
To compare the pattern of inflammatory response in patients with COPD and / or emphysema, with and without HIV infection
Tijdsspanne: Cross-sectional
|
Cross-sectional
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Melchor Riera, MD, Hospital Universitario Son Dureta
Publicaties en nuttige links
Nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- RNA-virusinfecties
- Virusziekten
- Infecties
- Door bloed overgedragen infecties
- Overdraagbare ziekten
- Seksueel overdraagbare aandoeningen, viraal
- Seksueel overdraagbare aandoeningen
- Lentivirus-infecties
- Retroviridae-infecties
- Immunologische deficiëntie syndromen
- Ziekten van het immuunsysteem
- HIV-infecties
Andere studie-ID-nummers
- IB956/08 IP
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