EuroSIDA - Clinical and Virological Outcome of European Patients Infected With HIV (EuroSIDA)

October 17, 2019 updated by: Jens D Lundgren, MD, Rigshospitalet, Denmark

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.

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.

Study Overview

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.

Study Type

Observational

Enrollment (Actual)

23000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Buenos Aires, Argentina
        • Hospital JM Ramos Mejia
      • Innsbruck, Austria
        • Medical University Insbruck
      • Vienna, Austria
        • Otto Wagner Spital
      • Gomel, Belarus
        • GOCGEIOZ - Gomel Regional Centre for Hygiene
      • Gomel, Belarus
        • Gomel State Medical University
      • Minsk, Belarus
        • Belarus State Medical University
      • Antwerp, Belgium
        • Institute of Tropical Medicine
      • Brussels, Belgium
        • CHU Saint-Pierre
      • Gent, Belgium
        • University Ziekenhuis Gent
      • Sarajevo, Bosnia and Herzegovina
        • Klinicki centar Univerziteta Sarajevo (KCUS)
      • Zagreb, Croatia
        • University Hospital of Infectious Diseases
      • Plzeň, Czechia
        • Charles University Hospital Plzen
      • Prague, Czechia
        • Faculty Hospital Bulovka
      • Copenhagen, Denmark
        • Rigshospitalet
      • Hillerød, Denmark
        • Hilleroed Sygehus
      • Hvidovre, Denmark
        • Hvidovre Universitets Hospital
      • Odense, Denmark
        • Odense Universitetshospital
      • Roskilde, Denmark
        • Roskilde Sygehus
      • Skejby, Denmark
        • Aarhus Universitetshospital Skejby
      • Kohtla-Järve, Estonia
        • Narva AIDS Centre
      • Tallinn, Estonia
        • West-Tallinn Central Hospital
      • Helsinki, Finland
        • Helsinki University Central Hospital
      • Bordeaux, France
        • INSERM, Université Bordeaux Segalen
      • Lyon, France
        • Hopital Edouard Herriot
      • Lyon, France
        • Hospital de la Croix Rousse
      • Nice, France
        • CHU Nice Hopital de l' Archet 1
      • Paris, France
        • Hopital Necker-Enfants Malades
      • Paris, France
        • Hospital Saint Antoine
      • Paris, France
        • Hôpital de la Pitié-Salpétière
      • Paris, France
        • Hôtel-Dieu Hospital
      • Tbilisi, Georgia
        • Georgian AIDS and Clinical Immunology Research Center
      • Bonn, Germany
        • University Hospital Bonn
      • Cologne, Germany
        • University Hospital Cologne
      • Eppendorf, Germany
        • University Clinic Hamburg Eppendorf
      • Frankfurt am Main, Germany
        • J.W.Goethe University Hospital
      • Hamburg, Germany
        • ICH Study Center
      • Hamburg, Germany
        • Bernhard Nocht Institut für Tropenmedizin
      • Hannover, Germany
        • Mediziniche Hochschule Hannover
      • München, Germany
        • Ludwig-Maximilians-Universität, Medizinische Poliklinik
      • Athens, Greece
        • Ippokration General Hospital
      • Athens, Greece
        • 1st I.K.A Hospital of Athens
      • Athens, Greece
        • The General Hospital of Athens "G. Gennimatas"
      • Budapest, Hungary
        • Szent László Hospital
      • Reykjavik, Iceland
        • Landspitali University Hospital
      • Dublin, Ireland
        • St. James' Hospital
      • Haifa, Israel
        • Rambam Health Care Campus
      • Jerusalem, Israel
        • Hadassah Hospital
      • Rehovot, Israel
        • Kaplan Medical Center, AIDS Center Neve Or
      • Tel Aviv, Israel
        • Ichilov Hospital
      • Bergamo, Italy
        • Ospedale Riuniti, Divisione Malattie Infettive
      • Milano, Italy
        • Ospedale L. Sacco
      • Milano, Italy
        • Ospedale San Raffaele
      • Milano, Italy
        • Ospedale San Paulo
      • Modena, Italy
        • Università degli Studi di Modena
      • Napoli, Italy
        • Ospedale Cotugno, III Divisione Malattie Infettive
      • Rome, Italy
        • National Institute for Infectious Diseases
      • Rome, Italy
        • Poloclinico Umberto 1
      • Riga, Latvia
        • Infectology Center of Latvia
      • Vilnius, Lithuania
        • Vilnius University Hospital Santariskiu Klinikos
      • Vilnius, Lithuania
        • Infectious Diseases and Tuberculosis Hospital, Vilnius University Hospital branch
      • Luxembourg, Luxembourg
        • Centre Hospitalier de Luxembourg
      • Amsterdam, Netherlands
        • Academisch Ziekenhuis bij de Universiteit van Amsterdam
      • Oslo, Norway
        • Oslo Universitetssykehus
      • Bialystok, Poland
        • Uniwersytecki Szpital Kliniczny
      • Chorzow, Poland
        • Szpital Specjalistyczny, Osrodek Diagnostyki i Terapii AIDS
      • Gdansk, Poland
        • Medical University Gdansk
      • Lodz, Poland
        • Wojewodzki Szpital Specjalistyczny im. WI. Bieganskiego
      • Poznan, Poland
        • Poznan University of Medical Sciences
      • Szczecin, Poland
        • Pomeramian Academy of Medicine (PAM)
      • Warszawa, Poland
        • Wojewodzki Szpital Zakazny
      • Wroclaw, Poland
        • EMC Instytut Medyczny SA
      • Lisbon, Portugal
        • Hospital Santa Maria
      • Lisbon, Portugal
        • Hospital Curry Cabral
      • Lisbon, Portugal
        • Hospital de Egas Moniz
      • Bucuresti, Romania
        • Dr. Victor Babes Hospital
      • Kaliningrad, Russian Federation
        • Centre for HIV/AIDS & and infectious diseases
      • Nizhny Novgorod, Russian Federation
        • Nizhny Novgorod Scientific and Research Institute
      • St Petersburg, Russian Federation
        • St Petersburgs AIDS Centre
      • Veliky Novgorod, Russian Federation
        • Novgorod Centre for AIDS prevention and control
      • Belgrade, Serbia
        • The Institute for Infectious and Tropical Diseases
      • Bratislava, Slovakia
        • Slovak Medical University
      • Ljubljana, Slovenia
        • University Clinical Centre Ljubljana
      • Badalona, Spain
        • Hospital Universitari Germans Trias i Pujol
      • Barcelona, Spain
        • Hospital de la Santa Creu i Sant Pau
      • Barcelona, Spain
        • Hospital Clinic, University of Barcelona
      • Madrid, Spain
        • Hospital Ramón y Cajal
      • Madrid, Spain
        • Hospital La Paz
      • Madrid, Spain
        • Hospital Carlos III, Departamento de Enfermedades Infecciosas
      • Valencia, Spain
        • Consorcio Hospital General Universitario Valencia
      • Vitoria-Gasteiz, Spain
        • Hospital Universitario de Alava
      • Malmö, Sweden
        • Skåne University Hospital
      • Stockholm, Sweden
        • Södersjukhuset
      • Stockholm, Sweden
        • Karolinska University Hospital Huddinge
      • Basel, Switzerland
        • University Hospital Basel
      • Bern, Switzerland
        • University Hospital Bern
      • Genève, Switzerland
        • Hopital Cantonal Universitaire Geneve
      • Lausanne, Switzerland
        • Centre Hospitalier Universitaire Vaudois
      • St.Gallen, Switzerland
        • Kantonsspital St. Gallen
      • Zürich, Switzerland
        • University Hospital Zürich
      • Kharkiv, Ukraine
        • Kharkiv State Medical University
      • Luhansk, Ukraine
        • Luhansk AIDS Center
      • Lviv, Ukraine
        • Lviv Regional HIV/AIDS Prevention and Control CTR
      • Odessa, Ukraine
        • Odessa Region AIDS Center
      • Simferopol, Ukraine
        • Crimean Republican AIDS centre
      • Brighton, United Kingdom
        • Royal Sussex County Hospital
      • Edinburgh, United Kingdom
        • Western General Hospital
      • London, United Kingdom
        • University College London
      • London, United Kingdom
        • St. Mary's Hospital
      • London, United Kingdom
        • Royal London Hospital
      • London, United Kingdom
        • University College London, Mortimer Market Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patients under 16 years of age
  • Already enrolled in EuroSIDA through earlier cohort
  • Predefined number of patients has been reached

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From date of enrollment until the date of progression, lost to follow-up or death, whichever came first, assessed up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
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
Share of patients with undetectable viral load 12 weeks after cessation of therapy targeting HCV infection
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
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
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
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
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
From date of enrollment until the date of progression, lost to follow-up or death, whichever came first, assessed up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Gilles Wandeler, Dr. med., University of Bern, Switzerland.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1994

Primary Completion (Anticipated)

December 1, 2030

Study Completion (Anticipated)

December 1, 2030

Study Registration Dates

First Submitted

January 19, 2016

First Submitted That Met QC Criteria

February 29, 2016

First Posted (Estimate)

March 4, 2016

Study Record Updates

Last Update Posted (Actual)

October 21, 2019

Last Update Submitted That Met QC Criteria

October 17, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • The EuroSIDA Study
  • QLK2-2000-00773 (Other Grant/Funding Number: EC FP5 1998-2002)
  • LSHC-CT-2006-018632 (Other Grant/Funding Number: EC FP6 2002-2006)
  • Gilead EuroSIDA (Other Grant/Funding Number: Gilead)
  • GSK EuroSIDA (Other Grant/Funding Number: GlaxoSmithKline)
  • Janssen EuroSIDA (Other Grant/Funding Number: Janssen)
  • CT94-1637 (Other Grant/Funding Number: EC BIOMED 1)
  • CT97-2713 (Other Grant/Funding Number: EC BIOMED 2)
  • Pfizer EuroSIDA (Other Grant/Funding Number: Pfizer)
  • Merck EuroSIDA (Other Grant/Funding Number: Merck and Co)
  • BMS EuroSIDA (Other Grant/Funding Number: Bristol-Myers Squibb)
  • SNSF 108787 (Other Grant/Funding Number: The Swiss National Science Foundation)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Study Data/Documents

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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