EuroSIDA - Clinical and Virological Outcome of European Patients Infected With HIV
- Conditions
- Hepatitis CDiabetes MellitusKidney Failure, ChronicHepatitis BCoinfectionCardiovascular DiseasesHIVAIDSRenal InsufficiencyFractures, Bone
- Registration Number
- NCT02699736
- Lead Sponsor
- Rigshospitalet, Denmark
- Brief Summary
The EuroSIDA study is a prospective observational cohort study of 23,000+ patients followed in 100+ clinics in 35 European countries, Israel and Argentina. The study is the largest pan-European cohort study and few studies of a comparable design are available on a global scale. The EuroSIDA study is an ongoing collaboration and patients have been enrolled into the study through 11 cohorts since 1994.
The main objective of the study remains the same as in 1994: to prospectively study, clinical, therapeutic, demographic, virological and laboratory data from HIV-1 positive persons across Europe in order to determine their long-term virological, immunological and clinical outcomes.
Historically, EuroSIDA has been crucial in reporting key changes in the HIV epidemic, such as the dramatic changes in morbidity and mortality when combination anti-retroviral therapy (cART) was first introduced. As new anti-HCV treatment is introduced to HIV/HCV co-infected patients, it is important for EuroSIDA to remain in the forefront of investigating the treatment benefits and adverse effects.
All study documents, study status, newsletters, scientific publications and presentations are available online and are updated continuously at project website.
In general terms, the objective of the EuroSIDA study is 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 and HIV-related co-infections and co-morbidities, and (2) continue to provide and develop a surveillance system to describe temporal changes and regional differences in the clinical course of HIV and HIV-related co-infections and co-morbidities in Europe.
- Detailed Description
Abstract: There are currently over 1½ million people across Europe infected with HIV. The epidemic continues to intensify in the Eastern European region where prevalence of HIV will continue to increase in the years to come. There are significant problems with the management of this public health crisis. Available antiretroviral therapy (ART) - although extremely effective - does not eradicate HIV and hence has to be continued for life. Other limitations are the development of resistance, adverse effects of treatment, and the requirement for strict adherence. Despite these limitations, the widespread use of potent ART has resulted in a dramatic decrease in HIV-related mortality across Europe. As the incidence of AIDS has declined, the relative importance of co-morbidities and co-infections, such as chronic viral hepatitis and tuberculosis (TB), has increased. Around a third of all EuroSIDA patients are co-infected with hepatitis C virus (HCV), and liver-related death is now the second most common cause of death after AIDS. With the introduction of new more potent and better tolerated oral direct acting antivirals (DAAs) against HCV, major changes in the management and outcome HCV co-infection is anticipated in the coming years. However due to the high cost of DAAs, access to new treatment could vary substantially across Europe.
Over 23,000 consecutively enrolled HIV-1 positive patients from over 100 clinical centres in 35 European countries, Israel and Argentina - one quarter from the eastern region - are currently enrolled in EuroSIDA. New cohorts of patients are normally enrolled every 2-3 years to ensure all regions of Europe where the epidemic is prevalent are represented so the study will give timely information on the clinical presentation and outcome of European HIV-1 positive patients. In 2012, 2500 additional patients were enrolled into EuroSIDA cohort IX. To be at the forefront of investigating the benefits and adverse effects of new HCV treatment in co-infected patients, the EuroSIDA cohort X enrolled in 2014, consisted of 4000 HIV-1 patients positive for antibodies against HCV. The next cohort to be enrolled (cohort XI) in 2019 will consist of 1500 HIV-1 positive patients.
The EuroSIDA study group has now been working on the EuroSIDA study since 1994 and has several notable accomplishments to date, including publication of more than 200 papers in peer-reviewed journals (including the New England Journal of Medicine and the Lancet among others). The focus of EuroSIDA has naturally changed over this period, which demonstrates an eagerness to be flexible, dynamic, and focus on contemporary issues, and the study group is committed to continue working with such principles.
In recent years, EuroSIDA has, in addition to the scientific publications, prioritized capacity building in Eastern Europe with HIV seminars, hosting clinicians from Eastern Europe as European AIDS Clinical Society (EACS) students in the office of Copenhagen HIV Programme and sponsoring 2-3 young physicians from Eastern Europe to participate in a statistical course in London every year.
Most of the data are collected from the clinics as part of routine care. Additionally, the central plasma repository will be used to extend earlier studies of the viral epidemiology of HIV (resistance and subtypes).
Primary study objective: To prospectively study, clinical, therapeutic, demographic, virological and laboratory data from HIV-1 positive persons across Europe in order to determine the long-term virological, immunological and clinical outcome. The specific objectives, falling into four main categories, are as follows:
1. To examine the efficacy of ART and factors that limits this
2. To detect current or emerging late onset adverse events among patients on ART
3. To continue surveillance of HIV in clinics around Europe to describe temporal changes and regional difference
4. To monitor the uptake and outcome of HCV therapy and development of direct acting antivirals and compare differences between EuroSIDA regions
Study visits: Enrolment + follow-up Data collection: For all HIV-1 positive patients enrolled and under follow up, laboratory, therapeutic and clinical data on HIV, viral hepatitis and serious non-AIDS clinical events are collected, as well as demographic data and possible data on pregnancy and the HIV status of the newborn baby. The patients are seen within their clinics as required and according to their local physician. EuroSIDA does not involve patient interviews or study visits, the information is collected from patient notes twice a year until 2017 hereafter once a year.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 23000
- HIV-1 infected patients regardless of CD4 cell count and ART status
- Must be positive for antibodies against HCV regardless of HCV-RNA status, fibrosis stage and prior HCV therapy
- Patients under 16 years of age
- Already enrolled in EuroSIDA through earlier cohort
- Predefined number of patients has been reached
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of long-term virological, immunological and morbidity and mortality outcomes across different regions in Europe; and demographic, clinical, therapeutic and viral factors associated with these outcomes From date of enrollment until the date of progression, lost to follow-up or death, whichever came first, assessed up to 5 years EuroSIDA is a non-interventional epidemiological cohort study that collects structured data. Data is not collected real time, but in 6-monthly intervals. The clinical data is centered on collecting laboratory variables and ascertaining predefined meaningful clinical events as well as reasons for changing and or stopping treatment regimens. The observational cohort study concept means that EuroSIDA does not collect Adverse Events, Adverse Reactions, Serious Adverse Reactions or Suspected Unexpected Serious Adverse Reactions as defined by pharmacovigilance requirements for marketing authorization holders. However, EuroSIDA often analyses and reports specific clinical events of interest, occasionally related to drug classes, but more regularly with a focus on regional differences in treatment and care.
- Secondary Outcome Measures
Name Time Method Number of patients experiencing HIV-related events over time From date of enrollment until the date of progression, lost to follow-up or death, whichever came first, assessed up to 5 years Number of participants experiencing HIV-related events by region From date of enrollment until the date of progression, lost to follow-up or death, whichever came first, assessed up to 5 years Proportion of HCV infected patients who start treatment with direct acting antiretrovirals From date of enrollment until the date of progression, lost to follow-up or death, whichever came first, assessed up to 5 years Rate of sustained virologic response 12 (SVR12) in HCV-infected patients From date of enrollment until the date of progression, lost to follow-up or death, whichever came first, assessed up to 5 years Share of patients with undetectable viral load 12 weeks after cessation of therapy targeting HCV infection
Incidence of liver-related clinical outcomes in HCV-infected patients receiving HCV therapy From date of enrollment until the date of progression, lost to follow-up or death, whichever came first, assessed up to 5 years Incidence of non-liver-related clinical outcomes in HCV-infected patients receiving HCV therapy From date of enrollment until the date of progression, lost to follow-up or death, whichever came first, assessed up to 5 years Incidence of liver-related clinical outcomes in HCV-infected patients not receiving HCV therapy From date of enrollment until the date of progression, lost to follow-up or death, whichever came first, assessed up to 5 years Incidence of non-liver-related clinical outcomes in HCV-infected patients not receiving HCV therapy From date of enrollment until the date of progression, lost to follow-up or death, whichever came first, assessed up to 5 years Incidence of toxicities related to direct acting antivirals by regions From date of enrollment until the date of progression, lost to follow-up or death, whichever came first, assessed up to 5 years
Trial Locations
- Locations (110)
Ospedale San Paulo
🇮🇹Milano, Italy
CHU Saint-Pierre
🇧🇪Brussels, Belgium
Otto Wagner Spital
🇦🇹Vienna, Austria
Belarus State Medical University
🇧🇾Minsk, Belarus
Hospital JM Ramos Mejia
🇦🇷Buenos Aires, Argentina
GOCGEIOZ - Gomel Regional Centre for Hygiene
🇧🇾Gomel, Belarus
Medical University Insbruck
🇦🇹Innsbruck, Austria
Institute of Tropical Medicine
🇧🇪Antwerp, Belgium
Klinicki centar Univerziteta Sarajevo (KCUS)
🇧🇦Sarajevo, Bosnia and Herzegovina
Gomel State Medical University
🇧🇾Gomel, Belarus
University Hospital of Infectious Diseases
🇭🇷Zagreb, Croatia
Faculty Hospital Bulovka
🇨🇿Prague, Czechia
Charles University Hospital Plzeň
🇨🇿Plzeň, Czechia
University Ziekenhuis Gent
🇧🇪Gent, Belgium
West-Tallinn Central Hospital
🇪🇪Tallinn, Estonia
Helsinki University Central Hospital
🇫🇮Helsinki, Finland
Hôtel-Dieu Hospital
🇫🇷Paris, France
Narva AIDS Centre
🇪🇪Kohtla-Järve, Estonia
Rigshospitalet
🇩🇰Copenhagen, Denmark
Hilleroed Sygehus
🇩🇰Hillerød, Denmark
Hvidovre Universitets Hospital
🇩🇰Hvidovre, Denmark
Odense Universitetshospital
🇩🇰Odense, Denmark
Aarhus Universitetshospital Skejby
🇩🇰Skejby, Denmark
Roskilde Sygehus
🇩🇰Roskilde, Denmark
INSERM, Université Bordeaux Segalen
🇫🇷Bordeaux, France
Hospital Saint Antoine
🇫🇷Paris, France
Hôpital de la Pitié-Salpétière
🇫🇷Paris, France
Hôpital Necker-Enfants Malades
🇫🇷Paris, France
Hopital Edouard Herriot
🇫🇷Lyon, France
CHU Nice Hopital de l' Archet 1
🇫🇷Nice, France
Hospital de la Croix Rousse
🇫🇷Lyon, France
Georgian AIDS and Clinical Immunology Research Center
🇬🇪Tbilisi, Georgia
University Hospital Bonn
🇩🇪Bonn, Germany
University Hospital Cologne
🇩🇪Cologne, Germany
University Clinic Hamburg Eppendorf
🇩🇪Eppendorf, Germany
Ludwig-Maximilians-Universität, Medizinische Poliklinik
🇩🇪München, Germany
J.W.Goethe University Hospital
🇩🇪Frankfurt am Main, Germany
Bernhard Nocht Institut für Tropenmedizin
🇩🇪Hamburg, Germany
Mediziniche Hochschule Hannover
🇩🇪Hannover, Germany
The General Hospital of Athens "G. Gennimatas"
🇬🇷Athens, Greece
ICH Study Center
🇩🇪Hamburg, Germany
1st I.K.A Hospital of Athens
🇬🇷Athens, Greece
Ippokration General Hospital
🇬🇷Athens, Greece
Ichilov Hospital
🇮🇱Tel Aviv, Israel
Szent László Hospital
🇭🇺Budapest, Hungary
Landspitali University Hospital
🇮🇸Reykjavik, Iceland
St. James' Hospital
🇮🇪Dublin, Ireland
Rambam Health Care Campus
🇮🇱Haifa, Israel
Hadassah Hospital
🇮🇱Jerusalem, Israel
Ospedale San Raffaele
🇮🇹Milano, Italy
Università degli Studi di Modena
🇮🇹Modena, Italy
Kaplan Medical Center, AIDS Center Neve Or
🇮🇱Rehovot, Israel
Ospedale Riuniti, Divisione Malattie Infettive
🇮🇹Bergamo, Italy
Ospedale L. Sacco
🇮🇹Milano, Italy
Ospedale Cotugno, III Divisione Malattie Infettive
🇮🇹Napoli, Italy
National Institute for Infectious Diseases
🇮🇹Rome, Italy
Poloclinico Umberto 1
🇮🇹Rome, Italy
Infectology Center of Latvia
🇱🇻Riga, Latvia
Infectious Diseases and Tuberculosis Hospital, Vilnius University Hospital branch
🇱🇹Vilnius, Lithuania
Vilnius University Hospital Santariskiu Klinikos
🇱🇹Vilnius, Lithuania
Centre Hospitalier de Luxembourg
🇱🇺Luxembourg, Luxembourg
Szpital Specjalistyczny, Osrodek Diagnostyki i Terapii AIDS
🇵🇱Chorzow, Poland
Academisch Ziekenhuis bij de Universiteit van Amsterdam
🇳🇱Amsterdam, Netherlands
Oslo Universitetssykehus
🇳🇴Oslo, Norway
Uniwersytecki Szpital Kliniczny
🇵🇱Bialystok, Poland
Poznan University of Medical Sciences
🇵🇱Poznan, Poland
Wojewodzki Szpital Zakazny
🇵🇱Warszawa, Poland
EMC Instytut Medyczny SA
🇵🇱Wroclaw, Poland
Hospital Curry Cabral
🇵🇹Lisbon, Portugal
Medical University Gdansk
🇵🇱Gdansk, Poland
Wojewodzki Szpital Specjalistyczny im. WI. Bieganskiego
🇵🇱Lodz, Poland
Pomeramian Academy of Medicine (PAM)
🇵🇱Szczecin, Poland
Hospital de Egas Moniz
🇵🇹Lisbon, Portugal
Hospital Santa Maria
🇵🇹Lisbon, Portugal
Dr. Victor Babes Hospital
🇷🇴Bucuresti, Romania
Centre for HIV/AIDS & and infectious diseases
🇷🇺Kaliningrad, Russian Federation
Nizhny Novgorod Scientific and Research Institute
🇷🇺Nizhny Novgorod, Russian Federation
St Petersburgs AIDS Centre
🇷🇺St Petersburg, Russian Federation
Novgorod Centre for AIDS prevention and control
🇷🇺Veliky Novgorod, Russian Federation
The Institute for Infectious and Tropical Diseases
🇷🇸Belgrade, Serbia
Slovak Medical University
🇸🇰Bratislava, Slovakia
University Clinical Centre Ljubljana
🇸🇮Ljubljana, Slovenia
Hospital Universitari Germans Trias i Pujol
🇪🇸Badalona, Spain
Hospital Clínic, University of Barcelona
🇪🇸Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Hospital Carlos III, Departamento de Enfermedades Infecciosas
🇪🇸Madrid, Spain
Hospital La Paz
🇪🇸Madrid, Spain
Consorcio Hospital General Universitario Valencia
🇪🇸Valencia, Spain
Hospital Ramon y Cajal
🇪🇸Madrid, Spain
Hospital Universitario de Alava
🇪🇸Vitoria-Gasteiz, Spain
Skåne University Hospital
🇸🇪Malmö, Sweden
Karolinska University Hospital Huddinge
🇸🇪Stockholm, Sweden
Södersjukhuset
🇸🇪Stockholm, Sweden
University Hospital Basel
🇨🇭Basel, Switzerland
University Hospital Bern
🇨🇭Bern, Switzerland
Hopital Cantonal Universitaire Geneve
🇨🇭Genève, Switzerland
Centre hospitalier Universitaire Vaudois
🇨🇭Lausanne, Switzerland
Kantonsspital St. Gallen
🇨🇭St.Gallen, Switzerland
University Hospital Zürich
🇨🇭Zürich, Switzerland
Kharkiv State Medical University
🇺🇦Kharkiv, Ukraine
Luhansk AIDS Center
🇺🇦Luhansk, Ukraine
Odessa Region AIDS Center
🇺🇦Odessa, Ukraine
Lviv Regional HIV/AIDS Prevention and Control CTR
🇺🇦Lviv, Ukraine
Crimean Republican AIDS centre
🇺🇦Simferopol, Ukraine
University College London, Mortimer Market Centre
🇬🇧London, United Kingdom
University College London
🇬🇧London, United Kingdom
Royal Sussex County Hospital
🇬🇧Brighton, United Kingdom
Royal London Hospital
🇬🇧London, United Kingdom
Western General Hospital
🇬🇧Edinburgh, United Kingdom
St. Mary's Hospital
🇬🇧London, United Kingdom