Clinical trial NCT01639274: Human Immunodeficiency Virus (HIV)and Chronic Obstructive Pulmonary Disease (COPD)
Official title: Prevalence of Chronic Obstructive Pulmonary Disease in HIV-patient Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2012-07-12
Enrollment: 639
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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 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

Primary outcomes:
measure: Evaluation of Chronic obstructive pulmonary disease prevalence in a large population of HIV patients
timeFrame: one time each patient (one hour)
Secondary outcomes:
measure: Epidemiological characteristics of COPD in HIV population
timeFrame: one time each patient (1 hour)
Other outcomes:
Locations:
city: Nice
country: France
facility: Service d'Infectiologie - Hôpital de l'Archet
Study officials:
affiliation: CHU NICE
name: Karine RISSO, MD
role: PRINCIPAL_INVESTIGATOR
References: