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

9. juni 2011 opdateret af: Cimera

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):

  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

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

350

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Illes Balears
      • Palma de Mallorca, Illes Balears, Spanien, 07014
        • Hospital Universitario Son Dureta

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

40 år til 69 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Prevalence of airflow obstruction compatible with COPD in patients with HIV infection
Tidsramme: cross-sectional
cross-sectional

Sekundære resultatmål

Resultatmål
Tidsramme
To determine the prevalence (and severity) of emphysema (HRCT)
Tidsramme: Cross-sectional
Cross-sectional
To Identify risk factors associated with the development of COPD and / or emphysema
Tidsramme: Cross-sectional
Cross-sectional
To analyze the predictive value of measuring DLCO as a marker of emphysema by HRCT
Tidsramme: 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
Tidsramme: Cross-sectional
Cross-sectional
To compare the pattern of inflammatory response in patients with COPD and / or emphysema, with and without HIV infection
Tidsramme: Cross-sectional
Cross-sectional

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Efterforskere

  • Ledende efterforsker: Melchor Riera, MD, Hospital Universitario Son Dureta

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juli 2008

Primær færdiggørelse (Faktiske)

1. januar 2011

Studieafslutning (Faktiske)

1. januar 2011

Datoer for studieregistrering

Først indsendt

15. maj 2009

Først indsendt, der opfyldte QC-kriterier

18. maj 2009

Først opslået (Skøn)

19. maj 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

10. juni 2011

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. juni 2011

Sidst verificeret

1. juni 2011

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med HIV-infektioner

3
Abonner