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

NCT01639274 | Completed

• 1 other identifier: 11-PP-09
• Study Type: interventional
• Target: 639
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• Evaluation of Chronic obstructive pulmonary disease prevalence in a large population of HIV patients

  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.

  one time each patient (one hour)

Secondary Outcomes (1)

• Epidemiological characteristics of COPD in HIV population

  one time each patient (1 hour)

Study Arms (1)

COPD

OTHER

Other: COPD prevalence

Interventions

COPD prevalence OTHER

Determine prevalence of COPD

COPD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

Service d'Infectiologie - Hôpital de l'Archet

Nice, 06000, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Karine RISSO, MD

  CHU NICE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2012
• First Posted: July 12, 2012
• Study Start: January 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: November 8, 2013

Record last verified: 2013-11

Locations

FR (1)