Abstract
(Englisch)
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Despite recent improvement in prognosis of HIV-infected patients from across Europe due to use of powerful combination antiretroviral therapies, challenges persist-in relation to durability of responses and new co-morbidities. The primary objective of the EuroSIDA study is to collect demographic, clinical, therapeutic and laboratory data on patients with HIV infection to determine the long-term virological and clinical outcome for patients from Europe. 10.900 patients from63clinics in 20 European countries will be followed on a long-term basis (since1994), providing 40.500 person-years of follow-up. A plasma repository of 27.000samples will allow laboratory analyses related to HIV resistance and HIV, subtyping. The EuroSIDA main database will serve as a tool to study the course and evolution of chronic HIV infection in patients from across Europe in future. The partners have a proven record of highly productive collaboration.
A total of 40.500 prospective person-years of follow-up, 142.000 viral load measurements and 27.000 plasma samples will have been collected on the patients participating in EuroSIDA (follow-up up to 10 years). On the plasma samples, a total of 6.480 tests for resistance, 9.000 for HIV subtypes and 5.000 quality controls of viral load measurements will be done. A total of 32 manuscripts will be published in peer-reviewed journals detailing the findings related to the objectives listed above.
A total of 10.900 unselected patients from 63 clinical centres in 20 European countries will be followed-up prospectively on a long-term basis. In 1999, Poland, Czech Republic and Hungary entered EuroSIDA. Recruitment from Eastern Europe will continue in 2001 and 2003. A total of 8.541 patients have already been enrolled as part of the EuroSIDA 1994-1997 and 1997-2000 studies (6.557 remains under active follow-up). New patients will be recruited in 2001 and 2003. A standardised data collection is completed every 6 months on all actively followed patients, and an updated version of the main database is available for analysis shortly thereafter. The information collected includes: demography, all therapeutic interventions and all major clinical events. The study will collect extensive information on risk factors for and the occurrence of cardiovascular disease events. A central repository of plasma from patients under follow-up will be expanded (10.158samples already collected as of November 1999). These samples will be used to initiate extensive virological analysis of this unselected cohort of patients from across Europe. Presence of resistance in samples from untreated patients and from patients at various levels of response to antiretroviral therapies.
To continue a long-term, prospective collection of clinical, laboratory and therapeutic data as well as plasma on a large cohort of consecutive HIV infected patients from across Europe in order to:
(1) assess the factors associated with the clinical, immunological and virological course of HIV infection, including effect and toxicity of antiretroviral agents and other therapeutic interventions and resistance testing
(2) continue to provide and develop a surveillance system to describe temporal changes and regional differences in the clinical course of HIV, including:
i) the overall pattern of HIV-related diseases and death and the emergence of new diseases, including drug-related disease;
ii) the prevalence of patients with severe immunosuppression and high viral replication;
iii) the virological response to initial antiretroviral therapy;
iv) the prevalence of non-BHIV subtype infection;
v) trends over time in the development of antiretroviral resistance in untreated and treated patients.
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