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
  Purpose

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.


Condition Intervention
Chronic Obstructive Pulmonary Disease
Other: COPD prevalence

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Prevalence of Chronic Obstructive Pulmonary Disease in HIV-patient Population

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 639
Study Start Date: January 2012
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
COPD Other: COPD prevalence
Determine prevalence of COPD

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01639274

Locations
France
Service d'Infectiologie - Hôpital de l'Archet
Nice, France, 06000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
Principal Investigator: Karine RISSO, MD CHU Nice
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT01639274     History of Changes
Other Study ID Numbers: 11-PP-09
Study First Received: July 10, 2012
Last Updated: November 7, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes
France: The Commission nationale de l’informatique et des libertés

Additional relevant MeSH terms:
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Acquired Immunodeficiency Syndrome
HIV Infections
Respiratory Tract Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

ClinicalTrials.gov processed this record on September 22, 2014