- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Lieux d'étude
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Illes Balears
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Palma de Mallorca, Illes Balears, Espagne, 07014
- Hospital Universitario Son Dureta
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Prevalence of airflow obstruction compatible with COPD in patients with HIV infection
Délai: cross-sectional
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cross-sectional
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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To determine the prevalence (and severity) of emphysema (HRCT)
Délai: 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
Délai: Cross-sectional
|
Cross-sectional
|
|
To analyze the predictive value of measuring DLCO as a marker of emphysema by HRCT
Délai: 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
Délai: Cross-sectional
|
Cross-sectional
|
|
To compare the pattern of inflammatory response in patients with COPD and / or emphysema, with and without HIV infection
Délai: Cross-sectional
|
Cross-sectional
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Melchor Riera, MD, Hospital Universitario Son Dureta
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Infections par virus à ARN
- Maladies virales
- Infections
- Infections transmissibles par le sang
- Maladies transmissibles
- Maladies sexuellement transmissibles, virales
- Maladies sexuellement transmissibles
- Infections à lentivirus
- Infections à rétroviridae
- Syndromes d'immunodéficience
- Maladies du système immunitaire
- Infections à VIH
Autres numéros d'identification d'étude
- IB956/08 IP
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