An observational study in HIV, Hepatitis B and Hepatitis C, sponsored by Rigshospitalet, Denmark. Enrolling by invitation at 110 sites in 36 countries. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2024-04-12.
Sponsored by Rigshospitalet, Denmark · Observational
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.
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:
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.
1,045 studies on the registry are indexed under Hepatitis B; 139 are open to participants now.
This study's planned enrollment of 23,000 is above the median of 365 across 251 observational studies indexed under Hepatitis B.
Browse Hepatitis B studies →Rigshospitalet, Denmark is the lead sponsor of 1,007 studies on the registry; 175 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CD4 count
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 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
Share of patients with undetectable viral load 12 weeks after cessation of therapy targeting HCV infection
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
Showing the first 100 of 110 sites across 36 countries. Choose a country and city above to see the rest.
Plan to share: No
The record gives a start of Jan 1994, a primary completion of Dec 2030 and a completion of Dec 2030. It does not say whether these dates are actual or estimated.
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