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

NCT ID: NCT01639274

Last Updated: 2013-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

639 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-11-30

Brief Summary

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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

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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.

Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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COPD

Group Type OTHER

COPD prevalence

Intervention Type OTHER

Determine prevalence of COPD

Interventions

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COPD prevalence

Determine prevalence of COPD

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karine RISSO, MD

Role: PRINCIPAL_INVESTIGATOR

CHU NICE

Locations

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Service d'Infectiologie - Hôpital de l'Archet

Nice, , France

Site Status

Countries

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France

Other Identifiers

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11-PP-09

Identifier Type: -

Identifier Source: org_study_id