HIVEuroSIDANCT02699736
EuroSIDA - Clinical and Virological Outcome of European Patients Infected With HIV
An observational study of HIV and Hepatitis B, run by Copenhagen University Hospital, Rigshospitalet at 110 sites in 36 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- HIV, Hepatitis B, Hepatitis C
- How many people
- 23,000 participants
- Where
- 110 sitesin 36 countries
- Study dates
- Jan 1994to Dec 2030
- How long will I take part?
- 30 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The EuroSIDA study recruits HIV-1 positive patients above the age of 16 years in the proportions in which they are represented in the participating clinics, which ensures that women are proportionally represented in the study. Approximately 26% of the patients are women. The study does not intervene with the clinical management of the patients followed, but only collects information based on provider-patient interviews, from patient records and from plasma samples collected. Pregnant women may participate in the study, as no interference with their treatment or pregnancy in any way will take place. Data on frequency and outcome of pregnancy are collected in the study once a year.
Who may be able to join
- 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
Who cannot join
- Patients under 16 years of age
- Already enrolled in EuroSIDA through earlier cohort
- Predefined number of patients has been reached
Trial locations and contacts
110 sites in 36 countries. Contact the study team or a site near you to ask about taking part.
110 sites in 36 countries
France8 sites
INSERM, Université Bordeaux Segalen
Bordeaux
Hopital Edouard Herriot
Lyon
Hospital de la Croix Rousse
Lyon
CHU Nice Hopital de l' Archet 1
Nice
Hospital Saint Antoine
Paris
Hôpital de la Pitié-Salpétière
Paris
Hôpital Necker-Enfants Malades
Paris
Hôtel-Dieu Hospital
Paris
Germany8 sites
University Hospital Bonn
Bonn
University Hospital Cologne
Cologne
University Clinic Hamburg Eppendorf
Eppendorf
J.W.Goethe University Hospital
Frankfurt am Main
Bernhard Nocht Institut für Tropenmedizin
Hamburg
ICH Study Center
Hamburg
Mediziniche Hochschule Hannover
Hanover
Ludwig-Maximilians-Universität, Medizinische Poliklinik
München
Italy8 sites
Ospedale Riuniti, Divisione Malattie Infettive
Bergamo
Ospedale L. Sacco
Milan
Ospedale San Paulo
Milan
Ospedale San Raffaele
Milan
Università degli Studi di Modena
Modena
Ospedale Cotugno, III Divisione Malattie Infettive
Naples
National Institute for Infectious Diseases
Rome
Poloclinico Umberto 1
Rome
Poland8 sites
Uniwersytecki Szpital Kliniczny
Bialystok
Szpital Specjalistyczny, Osrodek Diagnostyki i Terapii AIDS
Chorzów
Medical University Gdansk
Gdansk
Wojewodzki Szpital Specjalistyczny im. WI. Bieganskiego
Lodz
Poznan University of Medical Sciences
Poznan
Pomeramian Academy of Medicine (PAM)
Szczecin
Wojewodzki Szpital Zakazny
Warsaw
EMC Instytut Medyczny SA
Wroclaw
Spain8 sites
Hospital Universitari Germans Trias i Pujol
Badalona
Hospital Clínic, University of Barcelona
Barcelona
Hospital de la Santa Creu i Sant Pau
Barcelona
Hospital Carlos III, Departamento de Enfermedades Infecciosas
Madrid
Hospital La Paz
Madrid
Hospital Ramon y Cajal
Madrid
Consorcio Hospital General Universitario Valencia
Valencia
Hospital Universitario de Alava
Vitoria-Gasteiz
Denmark6 sites
Rigshospitalet
Copenhagen
Hilleroed Sygehus
Hillerød
Hvidovre Universitets Hospital
Hvidovre
Odense Universitetshospital
Odense
Roskilde Sygehus
Roskilde
Aarhus Universitetshospital Skejby
Skejby
Switzerland6 sites
University Hospital Basel
Basel
University Hospital Bern
Bern
Hopital Cantonal Universitaire Geneve
Geneva
Centre hospitalier Universitaire Vaudois
Lausanne
Kantonsspital St. Gallen
Sankt Gallen
University Hospital Zürich
Zurich
United Kingdom6 sites
Royal Sussex County Hospital
Brighton
Western General Hospital
Edinburgh
Royal London Hospital
London
St. Mary's Hospital
London
University College London, Mortimer Market Centre
London
University College London
London
Ukraine5 sites
Kharkiv State Medical University
Kharkiv
Luhansk AIDS Center
Luhansk
Lviv Regional HIV/AIDS Prevention and Control CTR
Lviv
Odessa Region AIDS Center
Odesa
Crimean Republican AIDS centre
Simferopol
Israel4 sites
Rambam Health Care Campus
Haifa
Hadassah Hospital
Jerusalem
Kaplan Medical Center, AIDS Center Neve Or
Rehovot
Ichilov Hospital
Tel Aviv
Russia4 sites
Centre for HIV/AIDS & and infectious diseases
Kaliningrad
Nizhny Novgorod Scientific and Research Institute
Nizhny Novgorod
St Petersburgs AIDS Centre
Saint Petersburg
Novgorod Centre for AIDS prevention and control
Velikiy Novgorod
Belarus3 sites
GOCGEIOZ - Gomel Regional Centre for Hygiene
Homyel
Gomel State Medical University
Homyel
Belarus State Medical University
Minsk
Belgium3 sites
Institute of Tropical Medicine
Antwerp
CHU Saint-Pierre
Brussels
University Ziekenhuis Gent
Ghent
Greece3 sites
1st I.K.A Hospital of Athens
Athens
Ippokration General Hospital
Athens
The General Hospital of Athens "G. Gennimatas"
Athens
Portugal3 sites
Hospital Curry Cabral
Lisbon
Hospital de Egas Moniz
Lisbon
Hospital Santa Maria
Lisbon
Sweden3 sites
Skåne University Hospital
Malmö
Karolinska University Hospital Huddinge
Stockholm
Södersjukhuset
Stockholm
Czechia2 sites
Charles University Hospital Plzeň
Pilsen
Faculty Hospital Bulovka
Prague
Estonia2 sites
Narva AIDS Centre
Kohtla-Järve
West-Tallinn Central Hospital
Tallinn
Lithuania2 sites
Infectious Diseases and Tuberculosis Hospital, Vilnius University Hospital branch
Vilnius
Vilnius University Hospital Santariskiu Klinikos
Vilnius
Bosnia and Herzegovina1 site
Klinicki centar Univerziteta Sarajevo (KCUS)
Sarajevo
Netherlands1 site
Academisch Ziekenhuis bij de Universiteit van Amsterdam
Amsterdam
About this study
Official title: EuroSIDA Prospective Observational Cohort Study on Clinical and Virological Outcome of European Patients Infected With HIV
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.
Read more
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.
Read the 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:
- To examine the efficacy of ART and factors that limits this
- To detect current or emerging late onset adverse events among patients on ART
- To continue surveillance of HIV in clinics around Europe to describe temporal changes and regional difference
- 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.
- Conditions
- HIV, Hepatitis B, Hepatitis C, AIDS, Coinfection, Cardiovascular Diseases
- Keywords
- HIV, HIV-1, Hepatitis C, HCV, prospective, cohort, coinfection
- Medical subject headings
- Hepatitis B, Hepatitis C, Acquired Immunodeficiency Syndrome, Coinfection, Cardiovascular Diseases, Diabetes Mellitus, Acidosis, Lactic, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort I | Enrolled from August 1994. Patients to be included were those attending the out-patient clinic for a scheduled visit (i.e. appointment made more than 2 weeks before time of visit). For patients included in the study from 1994-1997, it was requested that the patients had a cluster of differentiation 4 (CD4) count < 500 cells/µL within the last 5 months before inclusion. For all HIV patients enrolled and under follow up, laboratory, therapeutic and clinical data are collected twice annually. Demographic data, date on pregnancy and serological evidence for infection with hepatitis B virus (HBV) and hepatitis C virus (HCV) are collected once annually. | |
| Cohort II | Enrolled from January 1996. Patients to be included were those attending the out-patient clinic for a scheduled visit (i.e. appointment made more than 2 weeks before time of visit). For patients included in the study from 1994-1997, it was requested that the patients had a cluster of differentiation 4 (CD4) count < 500 cells/µL within the last 5 months before inclusion. For all HIV patients enrolled and under follow up, laboratory, therapeutic and clinical data are collected twice annually. Demographic data, date on pregnancy and serological evidence for infection with hepatitis B virus (HBV) and hepatitis C virus (HCV) are collected once annually. | |
| Cohort III | Enrolled from February 1997. Patients to be included were those attending the out-patient clinic for a scheduled visit (i.e. appointment made more than 2 weeks before time of visit). For patients included in the study from 1994-1997, it was requested that the patients had a cluster of differentiation 4 (CD4) count < 500 cells/µL within the last 5 months before inclusion. For all HIV patients enrolled and under follow up, laboratory, therapeutic and clinical data are collected twice annually. Demographic data, date on pregnancy and serological evidence for infection with hepatitis B virus (HBV) and hepatitis C virus (HCV) are collected once annually. | |
| Cohort IV | Enrolled from March 1999. Patients to be included were those attending the out-patient clinic for a scheduled visit (i.e. appointment made more than 2 weeks before time of visit). The eligibility criteria of a cluster of differentiation 4 (CD4) count < 500 cells/µL within the last 5 months before inclusion has been removed for patients joining the study in 1999 and beyond, since the intention of the study is to include most patients eligible for antiretroviral therapy. For all HIV patients enrolled and under follow up, laboratory, therapeutic and clinical data are collected twice annually. Demographic data, date on pregnancy and serological evidence for infection with hepatitis B virus (HBV) and hepatitis C virus (HCV) are collected once annually. | |
| Cohort V | Patients to be included were those aged 16 years or older attending the out-patient clinic for a scheduled visit (i.e. appointment made more than 2 weeks before time of visit), regardless of cluster of differentiation 4 (CD4) cell count. For all HIV patients enrolled and under follow up, laboratory, therapeutic and clinical data are collected twice annually. Demographic data, date on pregnancy and serological evidence for infection with hepatitis B virus (HBV) and hepatitis C virus (HCV) are collected once annually. | |
| Cohort VI | Patients to be included were those aged 16 years or older attending the out-patient clinic for a scheduled visit (i.e. appointment made more than 2 weeks before time of visit), regardless of cluster of differentiation 4 (CD4) cell count. For all HIV patients enrolled and under follow up, laboratory, therapeutic and clinical data are collected twice annually. Demographic data, date on pregnancy and serological evidence for infection with hepatitis B virus (HBV) and hepatitis C virus (HCV) are collected once annually. | |
| Cohort VII | Patients to be included were those aged 16 years or older attending the out-patient clinic for a scheduled visit (i.e. appointment made more than 2 weeks before time of visit), regardless of cluster of differentiation 4 (CD4) cell count. For all HIV patients enrolled and under follow up, laboratory, therapeutic and clinical data are collected twice annually. Demographic data, date on pregnancy and serological evidence for infection with hepatitis B virus (HBV) and hepatitis C virus (HCV) are collected once annually. | |
| Cohort VIII | Patients to be included were those aged 16 years or older attending the out-patient clinic for a scheduled visit (i.e. appointment made more than 2 weeks before time of visit), regardless of cluster of differentiation 4 (CD4) cell count. For all HIV patients enrolled and under follow up, laboratory, therapeutic and clinical data are collected twice annually. Demographic data, date on pregnancy and serological evidence for infection with hepatitis B virus (HBV) and hepatitis C virus (HCV) are collected once annually. | |
| Cohort IX | Enrolled from December 2011. Patients to be included were those aged 16 years or older attending the out-patient clinic for a scheduled visit (i.e. appointment made more than 2 weeks before time of visit), regardless of cluster of differentiation 4 (CD4) cell count. For all HIV patients enrolled and under follow up, laboratory, therapeutic and clinical data are collected twice annually. Demographic data, date on pregnancy and serological evidence for infection with hepatitis B virus (HBV) and hepatitis C virus (HCV) are collected once annually. | |
| Cohort X | All patients should be consecutive patients (except those already enrolled in EuroSIDA), or patients who had a scheduled visit (i.e. those who made an appointment >2 weeks prior to their visit) in the outpatient clinic regardless of cluster of differentiation 4 (CD4) cell count and ART status). Enroll patients of 16 years or older and positive for antibodies against hepatitis C virus (regardless of HCV-RNA status, fibrosis stage and prior treatment against hepatitis C). For all HIV patients enrolled and under follow up, laboratory, therapeutic and clinical data are collected twice annually. Demographic data, date on pregnancy and serological evidence for infection with hepatitis B virus (HBV) and hepatitis C virus (HCV) are collected once annually. | |
| Cohort XI | HIV-1 positive persons ≥18 years of age, not already enrolled in EuroSIDA, are eligible for inclusion. Participants should be enrolled consecutively in one of the following two groups: 1. Participants who have started integrase inhibitor (INSTI) based antiretroviral therapy (ART) after 1/1/2012 and have a CD4 cell count and HIV-RNA available in the 12 months prior to starting INSTI or within 3 months after starting INSTI 2. If participants have not started INSTI, they should be included providing they have a CD4/HIV-RNA in the 12 months prior to baseline or within 3 months after baseline. For all patients enrolled and under follow up, laboratory, therapeutic, clinical and demographic data, date on pregnancy and data on hepatitis B virus (HBV) and hepatitis C virus (HCV) are collected once annually. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
Measured: From date of enrollment until the date of progression, lost to follow-up or death, whichever came first, assessed up to 5 years
Secondary outcomes (9)
Number of patients experiencing HIV-related events over time
Measured: 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
Measured: 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
Measured: 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
Share of patients with undetectable viral load 12 weeks after cessation of therapy targeting HCV infection
Measured: 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 receiving HCV therapy
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From date of enrollment until the date of progression, lost to follow-up or death, whichever came first, assessed up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2016 (estimated)
- Study startJan 1994
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (245)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23,000 participants (estimated)
- Target duration
- 30 Years
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- University College, London
- Responsible party
- Principal investigator, Jens D Lundgren, MD, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Gilles Wandeler, Dr. med., Study chair, University of Bern, Switzerland.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02699736
- Sponsor's protocol ID
- The EuroSIDA Study
- Other IDs
- QLK2-2000-00773, LSHC-CT-2006-018632, Gilead EuroSIDA, GSK EuroSIDA, Janssen EuroSIDA, CT94-1637, CT97-2713, Pfizer EuroSIDA
- Acronym
- EuroSIDA
- Status last verified
- Apr 2024
- First submitted
- 19 Jan 2016
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Hill A, Grossman H, Cohen C, Nadler J, Peeters M. Modelling-based prediction of clinical benefits from etravirine in the TMC125-C223 trial. HIV Clin Trials. 2007 Mar-Apr;8(2):68-76. doi: 10.1310/hct0802-68.
PubMed 17507322Carter M. EuroSIDA cohort: 9% coinfected with HIV/HBV. IAPAC Mon. 2005 Apr;11(4):110. No abstract available.
PubMed 16110550Podlekareva D, Grint D, Karpov I, Rakmanova A, Mansinho K, Chentsova N, Zeltina I, Losso M, Parczewski M, Lundgren JD, Mocroft A, Kirk O; EuroSIDA in EuroCoord. Changing utilization of Stavudine (d4T) in HIV-positive people in 2006-2013 in the EuroSIDA study. HIV Med. 2015 Oct;16(9):533-43. doi: 10.1111/hiv.12254. Epub 2015 May 18.
PubMed 25988795Shepherd L, Borges AH, Ravn L, Harvey R, Jean-Paul V, Bower M, Grulich A, Silverberg M, De Wit S, Kirk O, Lundgren J, Mocroft A; EuroSIDA in Eurocoord. Predictive value of prostate-specific antigen for prostate cancer: a nested case-control study in EuroSIDA. J Int AIDS Soc. 2014 Nov 2;17(4 Suppl 3):19510. doi: 10.7448/IAS.17.4.19510. eCollection 2014.
PubMed 25394019Laut KG, Mocroft A, Lazarus J, Reiss P, Rockstroh J, Karpov I, Rakhmanova A, Knysz B, Moreno S, Gargalianos P, Lundgren J, Kirk O; Eurosida in Eurocoord. Regional differences in self-reported HIV care and management in the EuroSIDA study. J Int AIDS Soc. 2014 Nov 2;17(4 Suppl 3):19504. doi: 10.7448/IAS.17.4.19504. eCollection 2014.
PubMed 25394013Peters L, Mocroft A, Lundgren J, Grint D, Kirk O, Rockstroh J. HIV and hepatitis C co-infection in Europe, Israel and Argentina: a EuroSIDA perspective. BMC Infect Dis. 2014;14 Suppl 6(Suppl 6):S13. doi: 10.1186/1471-2334-14-S6-S13. Epub 2014 Sep 19. No abstract available.
PubMed 25253564Grint D, Peters L, Schwarze-Zander C, Beniowski M, Pradier C, Battegay M, Jevtovic D, Soriano V, Lundgren JD, Rockstroh JK, Kirk O, Mocroft A; EuroSIDA in EuroCoord. Temporal changes and regional differences in treatment uptake of hepatitis C therapy in EuroSIDA. HIV Med. 2013 Nov;14(10):614-23. doi: 10.1111/hiv.12068. Epub 2013 Jul 19.
PubMed 23869664Podlekareva DN, Reekie J, Mocroft A, Losso M, Rakhmanova AG, Bakowska E, Karpov IA, Lazarus JV, Gatell J, Lundgren JD, Kirk O; EuroSIDA study in EuroCoord. Benchmarking HIV health care: from individual patient care to health care evaluation. An example from the EuroSIDA study. BMC Infect Dis. 2012 Sep 25;12:229. doi: 10.1186/1471-2334-12-229.
PubMed 23009317Reekie J, Kowalska JD, Karpov I, Rockstroh J, Karlsson A, Rakhmanova A, Horban A, Kirk O, Lundgren JD, Mocroft A; EuroSIDA in EuroCoord. Regional differences in AIDS and non-AIDS related mortality in HIV-positive individuals across Europe and Argentina: the EuroSIDA study. PLoS One. 2012;7(7):e41673. doi: 10.1371/journal.pone.0041673. Epub 2012 Jul 23.
PubMed 22911841Fox ZV, Cozzi-Lepri A, D'Arminio Monforte A, Karlsson A, Phillips AN, Kronborg G, Kjaer J, Clotet B, Lundgren JD; EuroSIDA. Predictors of having a resistance test following confirmed virological failure of combination antiretroviral therapy: data from EuroSIDA. Antivir Ther. 2011;16(5):781-5. doi: 10.3851/IMP1801.
PubMed 21817201Viard JP, Souberbielle JC, Kirk O, Reekie J, Knysz B, Losso M, Gatell J, Pedersen C, Bogner JR, Lundgren JD, Mocroft A; EuroSIDA Study Group. Vitamin D and clinical disease progression in HIV infection: results from the EuroSIDA study. AIDS. 2011 Jun 19;25(10):1305-15. doi: 10.1097/QAD.0b013e328347f6f7.
PubMed 21522006Kowalska JD, Mocroft A, Ledergerber B, Florence E, Ristola M, Begovac J, Sambatakou H, Pedersen C, Lundgren JD, Kirk O; Eurosida Study Group. A standardized algorithm for determining the underlying cause of death in HIV infection as AIDS or non-AIDS related: results from the EuroSIDA study. HIV Clin Trials. 2011 Mar-Apr;12(2):109-17. doi: 10.1310/hct1202-109.
PubMed 21498154Reekie J, Reiss P, Ledergerber B, Sedlacek D, Parczewski M, Gatell J, Katlama C, Fatkenheuer G, Lundgren JD, Mocroft A; EuroSIDA study group. A comparison of the long-term durability of nevirapine, efavirenz and lopinavir in routine clinical practice in Europe: a EuroSIDA study. HIV Med. 2011 May;12(5):259-68. doi: 10.1111/j.1468-1293.2010.00877.x. Epub 2010 Aug 31.
PubMed 20812948van Luin M, Bannister WP, Mocroft A, Reiss P, Di Perri G, Peytavin G, Molto J, Karlson A, Castagna A, Beniowski M, Lundgren JD, Burger DM; EuroSIDA Study Group. Absence of a relation between efavirenz plasma concentrations and toxicity-driven efavirenz discontinuations in the EuroSIDA study. Antivir Ther. 2009;14(1):75-83.
PubMed 19320239Podlekareva D, Bannister W, Mocroft A, Abrosimova L, Karpov I, Lundgren JD, Kirk O; EuroSIDA Study Group. The EuroSIDA study: Regional differences in the HIV-1 epidemic and treatment response to antiretroviral therapy among HIV-infected patients across Europe--a review of published results. Cent Eur J Public Health. 2008 Sep;16(3):99-105. doi: 10.21101/cejph.a3490.
PubMed 18935770
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EuroSIDA Prospective Observational Cohort Study on Clinical and Virological Outcome of European Patients Infected With HIV
- ClinicalTrials.gov ID
- NCT02699736
- Acronym / sponsor ID
- EuroSIDA / The EuroSIDA Study
- Conditions
- HIV, Hepatitis B, Hepatitis C, AIDS, Coinfection, Cardiovascular Diseases
- Keywords
- HIV, HIV-1, Hepatitis C, HCV, prospective, cohort, coinfection
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 23,000 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- University College, London
- Study start
- Jan 1994
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 4 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To examine the efficacy of ART and factors that limits this
- To detect current or emerging late onset adverse events among patients on ART
- To continue surveillance of HIV in clinics around Europe to describe temporal changes and regional difference
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Years
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Cohort I | – | –Enrolled from August 1994. Patients to be included were those attending the out-patient clinic for a scheduled visit (i.e. appointment made more than 2 weeks before time of visit). For patients included in the study from 1994-1997, it was requested that the patients had a cluster of differentiation 4 (CD4) count < 500 cells/µL within the last 5 months before inclusion. For all HIV patients enrolled and under follow up, laboratory, therapeutic and clinical data are collected twice annually. Demographic data, date on pregnancy and serological evidence for infection with hepatitis B virus (HBV) and hepatitis C virus (HCV) are collected once annually. |
| Cohort II | – | –Enrolled from January 1996. Patients to be included were those attending the out-patient clinic for a scheduled visit (i.e. appointment made more than 2 weeks before time of visit). For patients included in the study from 1994-1997, it was requested that the patients had a cluster of differentiation 4 (CD4) count < 500 cells/µL within the last 5 months before inclusion. For all HIV patients enrolled and under follow up, laboratory, therapeutic and clinical data are collected twice annually. Demographic data, date on pregnancy and serological evidence for infection with hepatitis B virus (HBV) and hepatitis C virus (HCV) are collected once annually. |
| Cohort III | – | –Enrolled from February 1997. Patients to be included were those attending the out-patient clinic for a scheduled visit (i.e. appointment made more than 2 weeks before time of visit). For patients included in the study from 1994-1997, it was requested that the patients had a cluster of differentiation 4 (CD4) count < 500 cells/µL within the last 5 months before inclusion. For all HIV patients enrolled and under follow up, laboratory, therapeutic and clinical data are collected twice annually. Demographic data, date on pregnancy and serological evidence for infection with hepatitis B virus (HBV) and hepatitis C virus (HCV) are collected once annually. |
| Cohort IV | – | –Enrolled from March 1999. Patients to be included were those attending the out-patient clinic for a scheduled visit (i.e. appointment made more than 2 weeks before time of visit). The eligibility criteria of a cluster of differentiation 4 (CD4) count < 500 cells/µL within the last 5 months before inclusion has been removed for patients joining the study in 1999 and beyond, since the intention of the study is to include most patients eligible for antiretroviral therapy. For all HIV patients enrolled and under follow up, laboratory, therapeutic and clinical data are collected twice annually. Demographic data, date on pregnancy and serological evidence for infection with hepatitis B virus (HBV) and hepatitis C virus (HCV) are collected once annually. |
| Cohort V | – | –Patients to be included were those aged 16 years or older attending the out-patient clinic for a scheduled visit (i.e. appointment made more than 2 weeks before time of visit), regardless of cluster of differentiation 4 (CD4) cell count. For all HIV patients enrolled and under follow up, laboratory, therapeutic and clinical data are collected twice annually. Demographic data, date on pregnancy and serological evidence for infection with hepatitis B virus (HBV) and hepatitis C virus (HCV) are collected once annually. |
| Cohort VI | – | –Patients to be included were those aged 16 years or older attending the out-patient clinic for a scheduled visit (i.e. appointment made more than 2 weeks before time of visit), regardless of cluster of differentiation 4 (CD4) cell count. For all HIV patients enrolled and under follow up, laboratory, therapeutic and clinical data are collected twice annually. Demographic data, date on pregnancy and serological evidence for infection with hepatitis B virus (HBV) and hepatitis C virus (HCV) are collected once annually. |
| Cohort VII | – | –Patients to be included were those aged 16 years or older attending the out-patient clinic for a scheduled visit (i.e. appointment made more than 2 weeks before time of visit), regardless of cluster of differentiation 4 (CD4) cell count. For all HIV patients enrolled and under follow up, laboratory, therapeutic and clinical data are collected twice annually. Demographic data, date on pregnancy and serological evidence for infection with hepatitis B virus (HBV) and hepatitis C virus (HCV) are collected once annually. |
| Cohort VIII | – | –Patients to be included were those aged 16 years or older attending the out-patient clinic for a scheduled visit (i.e. appointment made more than 2 weeks before time of visit), regardless of cluster of differentiation 4 (CD4) cell count. For all HIV patients enrolled and under follow up, laboratory, therapeutic and clinical data are collected twice annually. Demographic data, date on pregnancy and serological evidence for infection with hepatitis B virus (HBV) and hepatitis C virus (HCV) are collected once annually. |
| Cohort IX | – | –Enrolled from December 2011. Patients to be included were those aged 16 years or older attending the out-patient clinic for a scheduled visit (i.e. appointment made more than 2 weeks before time of visit), regardless of cluster of differentiation 4 (CD4) cell count. For all HIV patients enrolled and under follow up, laboratory, therapeutic and clinical data are collected twice annually. Demographic data, date on pregnancy and serological evidence for infection with hepatitis B virus (HBV) and hepatitis C virus (HCV) are collected once annually. |
| Cohort X | – | –All patients should be consecutive patients (except those already enrolled in EuroSIDA), or patients who had a scheduled visit (i.e. those who made an appointment >2 weeks prior to their visit) in the outpatient clinic regardless of cluster of differentiation 4 (CD4) cell count and ART status). Enroll patients of 16 years or older and positive for antibodies against hepatitis C virus (regardless of HCV-RNA status, fibrosis stage and prior treatment against hepatitis C). For all HIV patients enrolled and under follow up, laboratory, therapeutic and clinical data are collected twice annually. Demographic data, date on pregnancy and serological evidence for infection with hepatitis B virus (HBV) and hepatitis C virus (HCV) are collected once annually. |
| Cohort XI | – | –HIV-1 positive persons ≥18 years of age, not already enrolled in EuroSIDA, are eligible for inclusion. Participants should be enrolled consecutively in one of the following two groups: 1. Participants who have started integrase inhibitor (INSTI) based antiretroviral therapy (ART) after 1/1/2012 and have a CD4 cell count and HIV-RNA available in the 12 months prior to starting INSTI or within 3 months after starting INSTI 2. If participants have not started INSTI, they should be included providing they have a CD4/HIV-RNA in the 12 months prior to baseline or within 3 months after baseline. For all patients enrolled and under follow up, laboratory, therapeutic, clinical and demographic data, date on pregnancy and data on hepatitis B virus (HBV) and hepatitis C virus (HCV) are collected once annually. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The EuroSIDA study recruits HIV-1 positive patients above the age of 16 years in the proportions in which they are represented in the participating clinics, which ensures that women are proportionally represented in the study. Approximately 26% of the patients are women. The study does not intervene with the clinical management of the patients followed, but only collects information based on provider-patient interviews, from patient records and from plasma samples collected. Pregnant women may participate in the study, as no interference with their treatment or pregnancy in any way will take place. Data on frequency and outcome of pregnancy are collected in the study once a year.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Patients under 16 years of age
- Already enrolled in EuroSIDA through earlier cohort
- Predefined number of patients has been reached
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Time frame: 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.
9 secondary outcomes
Number of patients experiencing HIV-related events over time
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 receiving HCV therapy
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From date of enrollment until the date of progression, lost to follow-up or death, whichever came first, assessed up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Background: PubMed 17507322Hill A, Grossman H, Cohen C, Nadler J, Peeters M. Modelling-based prediction of clinical benefits from etravirine in the TMC125-C223 trial. HIV Clin Trials. 2007 Mar-Apr;8(2):68-76. doi: 10.1310/hct0802-68.
- Background: PubMed 16110550Carter M. EuroSIDA cohort: 9% coinfected with HIV/HBV. IAPAC Mon. 2005 Apr;11(4):110. No abstract available.
- Results publication: PubMed 25988795Podlekareva D, Grint D, Karpov I, Rakmanova A, Mansinho K, Chentsova N, Zeltina I, Losso M, Parczewski M, Lundgren JD, Mocroft A, Kirk O; EuroSIDA in EuroCoord. Changing utilization of Stavudine (d4T) in HIV-positive people in 2006-2013 in the EuroSIDA study. HIV Med. 2015 Oct;16(9):533-43. doi: 10.1111/hiv.12254. Epub 2015 May 18.
- Results publication: PubMed 25394019Shepherd L, Borges AH, Ravn L, Harvey R, Jean-Paul V, Bower M, Grulich A, Silverberg M, De Wit S, Kirk O, Lundgren J, Mocroft A; EuroSIDA in Eurocoord. Predictive value of prostate-specific antigen for prostate cancer: a nested case-control study in EuroSIDA. J Int AIDS Soc. 2014 Nov 2;17(4 Suppl 3):19510. doi: 10.7448/IAS.17.4.19510. eCollection 2014.
- Results publication: PubMed 25394013Laut KG, Mocroft A, Lazarus J, Reiss P, Rockstroh J, Karpov I, Rakhmanova A, Knysz B, Moreno S, Gargalianos P, Lundgren J, Kirk O; Eurosida in Eurocoord. Regional differences in self-reported HIV care and management in the EuroSIDA study. J Int AIDS Soc. 2014 Nov 2;17(4 Suppl 3):19504. doi: 10.7448/IAS.17.4.19504. eCollection 2014.
- Results publication: PubMed 25253564Peters L, Mocroft A, Lundgren J, Grint D, Kirk O, Rockstroh J. HIV and hepatitis C co-infection in Europe, Israel and Argentina: a EuroSIDA perspective. BMC Infect Dis. 2014;14 Suppl 6(Suppl 6):S13. doi: 10.1186/1471-2334-14-S6-S13. Epub 2014 Sep 19. No abstract available.
- Results publication: PubMed 23869664Grint D, Peters L, Schwarze-Zander C, Beniowski M, Pradier C, Battegay M, Jevtovic D, Soriano V, Lundgren JD, Rockstroh JK, Kirk O, Mocroft A; EuroSIDA in EuroCoord. Temporal changes and regional differences in treatment uptake of hepatitis C therapy in EuroSIDA. HIV Med. 2013 Nov;14(10):614-23. doi: 10.1111/hiv.12068. Epub 2013 Jul 19.
- Results publication: PubMed 23009317Podlekareva DN, Reekie J, Mocroft A, Losso M, Rakhmanova AG, Bakowska E, Karpov IA, Lazarus JV, Gatell J, Lundgren JD, Kirk O; EuroSIDA study in EuroCoord. Benchmarking HIV health care: from individual patient care to health care evaluation. An example from the EuroSIDA study. BMC Infect Dis. 2012 Sep 25;12:229. doi: 10.1186/1471-2334-12-229.
- Results publication: PubMed 22911841Reekie J, Kowalska JD, Karpov I, Rockstroh J, Karlsson A, Rakhmanova A, Horban A, Kirk O, Lundgren JD, Mocroft A; EuroSIDA in EuroCoord. Regional differences in AIDS and non-AIDS related mortality in HIV-positive individuals across Europe and Argentina: the EuroSIDA study. PLoS One. 2012;7(7):e41673. doi: 10.1371/journal.pone.0041673. Epub 2012 Jul 23.
- Results publication: PubMed 21817201Fox ZV, Cozzi-Lepri A, D'Arminio Monforte A, Karlsson A, Phillips AN, Kronborg G, Kjaer J, Clotet B, Lundgren JD; EuroSIDA. Predictors of having a resistance test following confirmed virological failure of combination antiretroviral therapy: data from EuroSIDA. Antivir Ther. 2011;16(5):781-5. doi: 10.3851/IMP1801.
- Results publication: PubMed 21522006Viard JP, Souberbielle JC, Kirk O, Reekie J, Knysz B, Losso M, Gatell J, Pedersen C, Bogner JR, Lundgren JD, Mocroft A; EuroSIDA Study Group. Vitamin D and clinical disease progression in HIV infection: results from the EuroSIDA study. AIDS. 2011 Jun 19;25(10):1305-15. doi: 10.1097/QAD.0b013e328347f6f7.
- Results publication: PubMed 21498154Kowalska JD, Mocroft A, Ledergerber B, Florence E, Ristola M, Begovac J, Sambatakou H, Pedersen C, Lundgren JD, Kirk O; Eurosida Study Group. A standardized algorithm for determining the underlying cause of death in HIV infection as AIDS or non-AIDS related: results from the EuroSIDA study. HIV Clin Trials. 2011 Mar-Apr;12(2):109-17. doi: 10.1310/hct1202-109.
- EuroSIDALink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gilles Wandeler, Dr. med. study chair
University of Bern, Switzerland.
110 sites in 36 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV and Hepatitis B, run by Copenhagen University Hospital, Rigshospitalet at 110 sites in 36 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 110 sites in France, Germany, Italy, Poland, Spain and 31 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: From date of enrollment until the date of progression, lost to follow-up or death, whichever came first, assessed up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02699736, which also lists 245 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2024.