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EuroSIDA 2005-2009
HIV/AIDS
Framework programme: 6
Call: 3
Project number:
LSHP-CT-2006-018632
EC contribution: € 3 000 000
Duration: 48 months
Type: CA
Starting date: March 2006
Graphic element The EuroSIDA Network 2005-2009 – Clinical and Virological Outcome of Patients with HIV under Care in Europe
Keywords: HIV; AIDS; anti-HIV treatment; cohort; Europe

Summary:

The primary objective of EuroSIDA is to study demographic, clinical, therapeutic, virological and laboratory data from persons infected with HIV across Europe in order to determine the long-term virological, immunological and clinical outcome.

A total of 16,100 consecutive patients from 90 clinical centres in 33 European countries and Argentina – one quarter from Eastern Europe – will be followed-up on a long-term basis. New patients will be recruited periodically in 2005 and 2007, to ensure all the regions of Europe where the epidemic is prevalent are represented. This will allow the study to give timely information on the clinical presentation and outcome of European patients infected with HIV, as well as long-term follow-up. By November 2009, it is projected that a total of 83,000 prospective person-years of follow-up will have been collected within EuroSIDA (with a prospective follow-up of up to 15 years).

Most of the data collected from the clinics are derived from assessments done as part of routine care. Intense control programmes are implemented to ensure optimal quality of all aspects of the conduct of the study.

Over the years, EuroSIDA has led and/or contributed to a series of collaborations with other studies on clinical questions that the study was not sufficiently well powered to address by itself. Related to this, a series of activities within EuroSIDA has focused on standardising the methods used in observational studies and controlled clinical trials.

Background:

There are currently more than 1.5 million people across Europe infected with HIV. In recent years, the epidemic has intensified in the eastern region. The prevalence of HIV will continue to increase in the next five years. There are significant problems with the management of this public health crisis. Available antiretroviral therapy (ART), although extremely effective, does not eradicate HIV and thus has to be continued for life. Other limitations are the development of resistance, adverse effects of treatment and the requirement for strict adherence. ART is expensive and access to care varies tremendously across the European continent. As the course of the chronic infection continues, and if access to care is not dramatically improved, tuberculosis will become a major issue. The greatest concern is with multi-drug resistant tuberculosis which is most prevalent in the eastern part of Europe. In addition, most clinical research has studied people infected with the B subtype of HIV, but the non-B subtype is increasing in prevalence.

As of 2004, the EuroSIDA study was the largest, multinational (30 countries), prospective, cohort study of HIV patients in the world. This diversity allows EuroSIDA to compare epidemiological trends in progression of HIV infection and its complications between these countries and regions, in addition to studying long-term outcome. This assessment of long-term clinical outcome from treatment of HIV infection is of major importance to the patient community, healthcare provider and public health officials, among others. The median time from primary infection with HIV to the development of clinical disease (i.e. AIDS) – without drug intervention – is ten years, and drug intervention in the asymptomatic phase will extend this period by several years.

Aim:

  1. The aims of this study are:
  2. to examine the efficacy of ART and the factors that limit this
  3. to detect current or emerging late onset adverse events among patients on ART
  4. to continue surveillance of HIV in clinics around Europe to describe temporal changes and regional differences in the following:

Expected results:

Over the last four years, the extensive European collaborative work effort, plasma repository, virological laboratories, and databases have resulted in 40 articles being published in peer-reviewed scientific journals and, in addition, a total of 38 presentations at international HIV conferences during EuroSIDA 2000-2004. Several of these articles have had a substantial impact. This in itself has placed the EuroSIDA study in a highly respected position within the international field of HIV medicine and epidemiological science, which in combination with the large number of patients and the long-term follow-up gives the study a unique opportunity to continue the main objectives.

The EuroSIDA study has made it possible to document huge beneficial short and long-term clinical effects of providing HIV infected people with antiretroviral therapy, thus preventing AIDS disease and death.

We would like to highlight a few of the areas where the EuroSIDA study, through its scientific achievements, has had European added value by identifying that:

  1. Antiretroviral therapy (ART) results in virological, immunological and clinical long-term responses
  2. Interruption of OI prophylaxis in patients with ART immune reconstitution is safe
  3. Excess risk of cardiovascular disease correlated to the duration of cART
  4. Predictors of immune status and mortality among HIV-patients on ART with virological failure
  5. Prognostic and Surrogate Markers for Clinical Disease Progression
  6. Prognosis for AIDS/death in treatment-naive patients starting HAART primarily associated with baseline CD4 cell count
  7. Ability to predict virological response by different HIV-1 drug-resistance interpretation systems.

Potential applications:

The EuroSIDA study group has now been working on this study for more than ten years and has several notable accomplishments to date, including the publication of in excess of 50 papers in peer-reviewed journals.

Well-designed prospective cohort studies such as EuroSIDA are the primary supplement to randomised control trials, and will continue to provide insight in efficacy and safety of drug interventions. EuroSIDA can provide long-term follow-up on a large representative sample of patients followed in clinics, thereby providing information for immediate use by decision-makers as well as generating hypotheses on topics where considerable uncertainties exist.

Data from EuroSIDA is now used as an integrated part of the design of guidelines on how to manage the care of HIV-infected persons. There are presently few long-term, clinical endpoint randomised control trials and it is this important advantage of the EuroSIDA study which demonstrates why observational studies should continue to expand in the years to come.

Coordinator:

Jens D. Lundgren
Hvidovre University Hospital
Kettegaard Alle 30
2650 Hvidovre

Denmark
Tel: +45 36 32 30 15
Fax: +45 36 47 33 40
E-mail: jdl@cphiv.dk
Website: http://www.cphiv.dk

Partners:

Principal
Scientific
Participants
Official Address Other Information
2
A. Mocroft and
A.N. Phillips
Department of Primary Care and Population Studies
Royal Free and University College Medical School London
Royal Free Campus
Rowland Hill Street
UK-NW3 2PF London
United Kingdom
Tel: +44 20 7830 2239
Fax: +44 20 7794 1224
E-mail: andrew@pcps.ucl.ac.uk
 
3
L Ruiz
Hosp. Universitari Germans Trias i Pujol
HIV Unit and Retrovirology Lab
Crta. De Canyet s/n 2 Planta Maternal
ES-08 916 Badalona, Barcelona
Spain
Fax: +34 93 465 7602
E-mail: LRuiz@irsicaixa.es
4
D M Burger
Department of Clinical Pharmacy
553 University Medical Center
Nijmegen
Netherlands
E-mail: D.Burger@akf.umcn.nl
5
J K Rockstroh
Immunologische Ambulanz
University Hospital Bonn
Bonn
Germany
Tel: +49 228 2987-6558
Fax: +49 228 287 5034
E-mail: rockstroh@ukb.uni-bonn.de
6
Dr. V Soriano, MD
Hospital Carlos III
Servicia de Enf. Infecciosas
c/Sinesio Delgado 10
ES-28029 Madrid
Spain
Fax: +34 91 733 7628
E-mail: vsoriano@dragonet.es
7
B. Ledergerber
Division of Infectious Diseases,
Department of Internal Medicine
University Hospital Zurich
Ramistrasse 100 U Pol 33
CH-8091 Zurich
Switzerland
Tel: +41 1255 3357
Fax: +41 1255 3291
E-mail: infled@usz.unizh.ch
8
A Blaxhult
Department of Infectious Diseases
Karolinska University Hospital Solna
Stockholm
Sweden
Tel: +46 8 517 718 43
Fax: +46 8 517 718 01
E-mail: anders.blaxhult@karolinska.se
9
A M Johnson
Academic Department of Genitourinary Medicine
University College of London Medical School
The Mortimer Market Centre
Mortimer Market off Capper Street
UK-WC1E 6AU London
United Kingdom
Tel: +44 20 7380 9878/9892
Fax: +44 20 7380 9669
E-mail: a.johnson@pcps.ucl.ac.uk
10
P. Reiss
Academic Medical Center
University Hospital Amsterdam, Building T
Meibergdreef 9
NL-1105 AZ Amsterdam
Netherlands
Tel: +31 2 0566 4479
Fax: +31 2 0691 8821
E-mail: p.reiss@amc.uva.nl
11
N. Clumeck
Department of Infectious Diseases
C.H.U. Saint-Pierre Hospital
322, rue Haute
BE-1000 Brussels
Belgium
Tel: +32 2 535 4131
Fax: +32 2 539 3614
E-mail: crmiclum@ulb.ac.be
12
C. Katlama
Département de Médecine Tropicale
Hôpital de la Pitié-Salpêtrière
Boulevard de l’Hôpital 83
FR-75013 Paris, Cedex 13
France
Tel: +33 1 42 16 01 30
Fax: +33 1 42 16 01 26
E-mail: christine.katlama@psl.p-hop-paris.fr
13
S. Vella
Laboratory of Virology
Istituto Superiore di Sanità
Viale Regina Elena 299
IT-00161 Rome
Italy
Tel: +39 06 4938 7214
Fax: +39 06 4990 2012
E-mail: stefanovella@interbusiness.it
14
J M Gatell
Servicio Infecciones
Hospital Clinic i Provincial
Villaroel 170
ES-08 036 Barcelona
Spain
Tel: +34 9 3227 5430
Fax: +34 93 451 4438
E-mail: gatell@medicina.ub.es
15
F Antunes
Department of Infectious Diseases
Hospital Santa Maria
Lisbon
Portugal
Tel: +351 21 780 52 74
Fax: +351 2 179 762 42
E-mail: ip231874@sapo.pt
16
A. Horban
Centrum Diagnostyki i Therapii AIDS
Wojewodzki Szpital Zakariny
Wolska st. 37
PL-01-201 Warsawa
Poland
Tel: +48 22 63 20 611 and
22 33 55 225
Fax: +48 22 33 55 360
E-mail: ahorban@cdit-aids.med.pl
17
A Rakhmanova
Medical Academy
Botkin Hospital
St. Petersburg
Russia
Tel: +7 812 277 7737
Fax: +7 812 274 8302
E-mail: rakhmanova@peterlink.ru

 
 
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