Prevalence of Liver Fibrosis and Progression of Liver Fibrosis

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2010 by University of Zurich
Sponsor:
Collaborator:
Swiss HIV Cohort Study
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
NCT01208376
First received: September 22, 2010
Last updated: September 27, 2010
Last verified: September 2010

September 22, 2010
September 27, 2010
October 2010
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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.
 
Not yet recruiting
200
October 2014
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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
Kovari Kramer Helen, MD, University Hospital Zurich, Division of Infectious Diseases
University of Zurich
Swiss HIV Cohort Study
Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich
University of Zurich
September 2010

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