Human Immunodeficiency Virus (HIV)and Chronic Obstructive Pulmonary Disease (COPD) (HIV and COPD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT01639274
First received: July 10, 2012
Last updated: November 7, 2013
Last verified: November 2013

July 10, 2012
November 7, 2013
January 2012
November 2013   (final data collection date for primary outcome measure)
Evaluation of Chronic obstructive pulmonary disease prevalence in a large population of HIV patients [ Time Frame: one time each patient (one hour) ] [ Designated as safety issue: No ]
An auto-questionnaire will be given to each patient included in the study (concern respiratory symptoms, tobacco consummation, illicit drug use, various respiratory exposition and lifestyle). Each patient will release a rapid evaluation of respiratory capacity with COPD-6. Patients screened with abnormal respiratory symptoms on auto-questionnaire, or with a risk of COPD ranked from high to moderate by COPD-6 test will benefit of a conventional spirometry.
Same as current
Complete list of historical versions of study NCT01639274 on ClinicalTrials.gov Archive Site
Epidemiological characteristics of COPD in HIV population [ Time Frame: one time each patient (1 hour) ] [ Designated as safety issue: No ]
Epidemiological characteristics of COPD in HIV population: age, severity of the disease compared to the GOLD classification, symptoms of chronic bronchitis, exacerbation frequency, immune statute, HAART exposure, lung opportunist infection, tobacco consumption, cannabis and others drugs consumption, professional exposition..Descriptive comparison of respiratory risk factors, immunity and HAART exposition between HIV patients with and without COPD.Define proportion of under-diagnose COPD in HIV population.
Same as current
Not Provided
Not Provided
 
Human Immunodeficiency Virus (HIV)and Chronic Obstructive Pulmonary Disease (COPD)
Prevalence of Chronic Obstructive Pulmonary Disease in HIV-patient Population

Highly active antiretroviral therapy (HAART) has considerably improved survival of HIV-infected patients. Opportunist diseases and cancers linked to immunodepression have largely regressed. Challenge is now the management of cardio-vascular diseases, nephrologic, neurologic, osteo-articular diseases, chronic hepatitis and cancer no linked to immunodepression. All this comorbidities are more reported in HIV-infected patients than in general non-HIV infected patients. Those are directly linked to the effect of chronic HIV-infection on ageing, metabolic effects of HAART, and way of life characterising this population.

Chronic obstructive pulmonary disease (COPD) results from tobacco consumption. Bronchial chronic infection, immunity, and ageing are also involved in the physiopathology of COPD. This disease has never been evaluated in a large prospective cohort of HIV-infected patients whereas there is a known increase of tobacco consumption and pulmonary infection in this population regardless to the general population.

Characterisation of COPD disease in HIV patients will allow us to make an hypothetic epidemiological link between HIV- HAART and COPD independently of tobacco consumption, and to study different physiopathologic hypothesis evocated in COPD genesis, like an accelerate pulmonary ageing.

The management of HIV is mainly represented by its commorbidities (cardio-vascular disease, nephrologic, neurologic, osteo-articular disease, chronic hepatitis and cancer no linked to immunodepression). COPD prevalence has never been studied in HIV population. In consequence, there is no guideline about the screening, treatment or follow-up of COPD in HIV patients. However this population seems particularly at risk to develop COPD because of high tobacco consumption and accelerate ageing. Thus, we need an epidemiologic study to understand the prevalence of COPD in HIV population in order to organize a specific screening and follow-up. This is supported by an improvement of COPD if early managed. On top of that, COPD screening will increase awareness of HIV patients on the problematic of tobacco consumption.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Chronic Obstructive Pulmonary Disease
Other: COPD prevalence
Determine prevalence of COPD
COPD
Intervention: Other: COPD prevalence
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
639
November 2013
November 2013   (final data collection date for primary outcome measure)

Inclusion criteria:

  • HIV seropositivity
  • Age > 18 years
  • Written aggreeing
  • Affiliated or profit of a social coverage

Non inclusion criteria:

  • Age < 18 years old
  • Actual infectious pneumonia
  • COPD exacerbation last 2 months *
  • Recent (less than 1 month) myocardial infarction
  • Thoracic or abdominal pain
  • Enable to answer question secondary to mental deficienty**
  • Physic or mental incapacity to realise COPD-6 or spirometery
  • Urinary incontinency with effort
  • Prisoner
  • Refuse of consent or incapacity to give his consent
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01639274
11-PP-09
No
Centre Hospitalier Universitaire de Nice
Centre Hospitalier Universitaire de Nice
Not Provided
Principal Investigator: Karine RISSO, MD CHU Nice
Centre Hospitalier Universitaire de Nice
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP