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Trial record 2 of 2 for:    15802978 [PUBMED-IDS]

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

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ClinicalTrials.gov Identifier: NCT02699736
Recruitment Status : Enrolling by invitation
First Posted : March 4, 2016
Last Update Posted : April 27, 2018
Sponsor:
Collaborator:
University College, London
Information provided by (Responsible Party):
CHIP Team, Rigshospitalet, Denmark

Brief Summary:

The EuroSIDA study is a prospective observational cohort study of 20,000+ 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 10 cohorts since 1994.

The main objective of the study remains the same as in1994: 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.


Condition or disease
HIV Hepatitis B Hepatitis C AIDS Coinfection Cardiovascular Diseases Diabetes Mellitus Acidosis, Lactic Renal Insufficiency Fractures, Bone End Stage Liver Disease Kidney Failure, Chronic Proteinuria

  Show Detailed Description

Study Type : Observational [Patient Registry]
Actual Enrollment : 20852 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 30 Years
Official Title: EuroSIDA Prospective Observational Cohort Study on Clinical and Virological Outcome of European Patients Infected With HIV
Study Start Date : January 1994
Estimated Primary Completion Date : December 2030
Estimated Study Completion Date : December 2030

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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

  5. 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 ]
  6. 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 ]
  7. 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 ]
  8. 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 ]
  9. 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 ]

Biospecimen Retention:   Samples Without DNA
2 x 1 ml plasma;


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02699736


  Show 110 Study Locations
Sponsors and Collaborators
Rigshospitalet, Denmark
University College, London
Investigators
Study Chair: Jürgen Rockstroh, Dr. med. Medical Faculty, University of Bonn

Additional Information:
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site

Publications of Results:
Engsig FN, Zangerle R, Katsarou O, Dabis F, Reiss P, Gill J, Porter K, Sabin C, Riordan A, Fätkenheuer G, Gutiérrez F, Raffi F, Kirk O, Mary-Krause M, Stephan C, de Olalla PG, Guest J, Samji H, Castagna A, d'Arminio Monforte A, Skaletz-Rorowski A, Ramos J, Lapadula G, Mussini C, Force L, Meyer L, Lampe F, Boufassa F, Bucher HC, De Wit S, Burkholder GA, Teira R, Justice AC, Sterling TR, M Crane H, Gerstoft J, Grarup J, May M, Chêne G, Ingle SM, Sterne J, Obel N; Antiretroviral Therapy Cohort Collaboration (ART-CC) and the Collaboration of Observational HIV Epidemiological Research Europe (COHERE) in EuroCoord. Long-term mortality in HIV-positive individuals virally suppressed for >3 years with incomplete CD4 recovery. Clin Infect Dis. 2014 May;58(9):1312-21. doi: 10.1093/cid/ciu038. Epub 2014 Jan 22.

Other Publications:
Responsible Party: CHIP Team, CHIP Administrative Director, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02699736     History of Changes
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 )
First Posted: March 4, 2016    Key Record Dates
Last Update Posted: April 27, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by CHIP Team, Rigshospitalet, Denmark:
HIV
HIV-1
Hepatitis C
HCV
prospective
cohort
coinfection

Additional relevant MeSH terms:
Diabetes Mellitus
Hepatitis
Hepatitis A
Hepatitis C
Cardiovascular Diseases
Hepatitis B
Liver Diseases
Renal Insufficiency
Proteinuria
Kidney Failure, Chronic
Acidosis
Coinfection
End Stage Liver Disease
Fractures, Bone
Acidosis, Lactic
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepadnaviridae Infections
DNA Virus Infections
Kidney Diseases
Urologic Diseases
Urination Disorders