Human Immunodeficiency Virus (HIV)and Chronic Obstructive Pulmonary Disease (COPD) (HIV and COPD)
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
COPD prevalence
Sponsored by
About this trial
This is an interventional diagnostic trial for Chronic Obstructive Pulmonary Disease
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
Sites / Locations
- Service d'Infectiologie - Hôpital de l'Archet
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
COPD
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Epidemiological characteristics of COPD in HIV population
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.
Full Information
NCT ID
NCT01639274
First Posted
July 10, 2012
Last Updated
November 7, 2013
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT01639274
Brief Title
Human Immunodeficiency Virus (HIV)and Chronic Obstructive Pulmonary Disease (COPD)
Acronym
HIV and COPD
Official Title
Prevalence of Chronic Obstructive Pulmonary Disease in HIV-patient Population
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
639 (Actual)
8. Arms, Groups, and Interventions
Arm Title
COPD
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
COPD prevalence
Intervention Description
Determine prevalence of COPD
Primary Outcome Measure Information:
Title
Evaluation of Chronic obstructive pulmonary disease prevalence in a large population of HIV patients
Description
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.
Time Frame
one time each patient (one hour)
Secondary Outcome Measure Information:
Title
Epidemiological characteristics of COPD in HIV population
Description
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.
Time Frame
one time each patient (1 hour)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karine RISSO, MD
Organizational Affiliation
CHU Nice
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service d'Infectiologie - Hôpital de l'Archet
City
Nice
ZIP/Postal Code
06000
Country
France
12. IPD Sharing Statement
Learn more about this trial
Human Immunodeficiency Virus (HIV)and Chronic Obstructive Pulmonary Disease (COPD)
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