Prevalence of Liver Fibrosis and Progression of Liver Fibrosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by University of Zurich
Sponsor:
Collaborator:
Swiss HIV Cohort Study
Information provided by (Responsible Party):
Helen Kovari-Kramer, University of Zurich
ClinicalTrials.gov Identifier:
NCT01208376
First received: September 22, 2010
Last updated: December 9, 2014
Last verified: December 2014

September 22, 2010
December 9, 2014
October 2010
August 2016   (final data collection date for primary outcome measure)
Liverfibrosis [ Time Frame: 3 years ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT01208376 on ClinicalTrials.gov Archive Site
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Prevalence of Liver Fibrosis and Progression of Liver Fibrosis
Prevalence of Liver Fibrosis and Progression of Liver Fibrosis in HIV-infected, Hepatitis C (HCV) and Hepatitis B (HBV) Seronegative Patients With Chronic Alanine Aminotransferase (ALT) Elevation

Little is known about the clinical significance of chronic alanine aminotransferase (ALT) elevation in HIV-infected patients without hepatitis B and C coinfection. Study aim is first to evaluate the prevalence of liver fibrosis and cirrhosis in HIV-infected patients with chronic ALT elevation and no chronic viral hepatitis using non-invasive diagnostic tests and second to find associated factors with significant fibrosis and cirrhosis. In a second longitudinal part we intend to assess fibrosis progression within 1 and 3 years.

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Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
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Probability Sample

HIV-infected, hepatitis B and C seronegative Patients With Chronic alanine aminotransferase (ALT) Elevation

HIV Infection and Chronic Alanine Aminotransferase Elevation
Other: Fibroscan
Fibroscan and Serum Fibrose-marker
Other Name: Fibroscan and Serum Fibrose-marker
  • unexplained chronic ALT elevation
    Case patients: HIV-infected, unexplained chronic alanine aminotransferase (ALT) elevation
    Intervention: Other: Fibroscan
  • always normal ALT
    Control patients: HIV-infected, always normal ALT values
    Intervention: Other: Fibroscan
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
August 2016
August 2016   (final data collection date for primary outcome measure)

Inclusion criteria: Case patients:

  • HIV-1 infection
  • no hepatitis B and C coinfection
  • chronic alanine aminotransferase (ALT) elevation after 1.1.2007
  • signed informed consent
  • no other common cause of liver disease

Control patients:

  • HIV-infection
  • no hepatitis B and C coinfection
  • no ALT elevation after 1.1.2002, the date when ALT values were regularly collected in the Swiss HIV Cohort Study (SHCS)
  • no known chronic liver disease

Exclusion criteria: please see inclusion criteria

Both
18 Years and older
No
Contact: 01 Studienregister MasterAdmins +41 (0)44 255 11 11
Switzerland
 
NCT01208376
SHCS 625
No
Helen Kovari-Kramer, University of Zurich
Helen Kovari-Kramer
Swiss HIV Cohort Study
Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich
University of Zurich
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP