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

Prevalencia, Factores de Riesgo y características patogénicas Diferenciales de EPOC y Enfisema en Pacientes Con infección VIH.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00904384
Acronym
HIV&COPD
Enrollment
350
Registered
2009-05-19
Start date
2008-07-31
Completion date
2011-01-31
Last updated
2011-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD, HIV Infections

Keywords

HIV+, COPD, emphysema

Brief summary

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

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.

Interventions

None listed

Sponsors

Hospital Universitari Son Dureta
CollaboratorOTHER
Cimera
Lead SponsorNETWORK

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
40 Years to 69 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Prevalence of airflow obstruction compatible with COPD in patients with HIV infectioncross-sectional

Secondary

MeasureTime frame
To determine the prevalence (and severity) of emphysema (HRCT)Cross-sectional
To Identify risk factors associated with the development of COPD and / or emphysemaCross-sectional
To analyze the predictive value of measuring DLCO as a marker of emphysema by HRCTCross-sectional
To determine the prevalence of lung function abnormalities deeming specific drug treatment (bronchodilators, inhaled corticosteroids) in the absence of clinical symptomsCross-sectional
To compare the pattern of inflammatory response in patients with COPD and / or emphysema, with and without HIV infectionCross-sectional

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026