- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Voraussichtlich)
Kontakte und Standorte
Studienorte
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Illes Balears
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Palma de Mallorca, Illes Balears, Spanien, 07014
- Hospital Universitario Son Dureta
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
|---|
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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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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Prevalence of airflow obstruction compatible with COPD in patients with HIV infection
Zeitfenster: cross-sectional
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cross-sectional
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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To determine the prevalence (and severity) of emphysema (HRCT)
Zeitfenster: 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
Zeitfenster: Cross-sectional
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Cross-sectional
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To analyze the predictive value of measuring DLCO as a marker of emphysema by HRCT
Zeitfenster: Cross-sectional
|
Cross-sectional
|
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To determine the prevalence of lung function abnormalities deeming specific drug treatment (bronchodilators, inhaled corticosteroids) in the absence of clinical symptoms
Zeitfenster: Cross-sectional
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Cross-sectional
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To compare the pattern of inflammatory response in patients with COPD and / or emphysema, with and without HIV infection
Zeitfenster: Cross-sectional
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Cross-sectional
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Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Melchor Riera, MD, Hospital Universitario Son Dureta
Publikationen und hilfreiche Links
Nützliche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- RNA-Virusinfektionen
- Viruserkrankungen
- Infektionen
- Durch Blut übertragene Infektionen
- Übertragbare Krankheiten
- Sexuell übertragbare Krankheiten, viral
- Sexuell übertragbare Krankheiten
- Lentivirus-Infektionen
- Retroviridae-Infektionen
- Immunologische Mangelsyndrome
- Erkrankungen des Immunsystems
- HIV-Infektionen
Andere Studien-ID-Nummern
- IB956/08 IP
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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