Human Immunodeficiency Virus (HIV)and Chronic Obstructive Pulmonary Disease (COPD) (HIV and COPD)
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| First Received Date ICMJE | July 10, 2012 | ||||||||
| Last Updated Date | July 10, 2012 | ||||||||
| Start Date ICMJE | January 2012 | ||||||||
| Estimated Primary Completion Date | January 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE |
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. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Human Immunodeficiency Virus (HIV)and Chronic Obstructive Pulmonary Disease (COPD) | ||||||||
| Official Title ICMJE | Prevalence of Chronic Obstructive Pulmonary Disease in HIV-patient Population | ||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
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| Condition ICMJE | Chronic Obstructive Pulmonary Disease | ||||||||
| Intervention ICMJE | Other: COPD prevalence
Determine prevalence of COPD |
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| Study Arm (s) | COPD
Intervention: Other: COPD prevalence |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 667 | ||||||||
| Estimated Completion Date | November 2013 | ||||||||
| Estimated Primary Completion Date | January 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion criteria:
Non inclusion criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | France | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01639274 | ||||||||
| Other Study ID Numbers ICMJE | 11-PP-09 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Centre Hospitalier Universitaire de Nice | ||||||||
| Study Sponsor ICMJE | Centre Hospitalier Universitaire de Nice | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Centre Hospitalier Universitaire de Nice | ||||||||
| Verification Date | July 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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