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Prevalence of Liver Fibrosis and Progression of Liver Fibrosis

This study is ongoing, but not recruiting participants.
Swiss HIV Cohort Study
Information provided by (Responsible Party):
Helen Kovari-Kramer, University of Zurich Identifier:
First received: September 22, 2010
Last updated: December 19, 2016
Last verified: May 2016
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.

Condition Intervention
HIV Infection and Chronic Alanine Aminotransferase Elevation
Other: Fibroscan

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: 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

Resource links provided by NLM:

Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Liverfibrosis [ Time Frame: 3 years ]

Enrollment: 195
Study Start Date: October 2010
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
unexplained chronic ALT elevation
Case patients: HIV-infected, unexplained chronic alanine aminotransferase (ALT) elevation
Other: Fibroscan
Fibroscan and Serum Fibrose-marker
Other Name: Fibroscan and Serum Fibrose-marker
always normal ALT
Control patients: HIV-infected, always normal ALT values
Other: Fibroscan
Fibroscan and Serum Fibrose-marker
Other Name: Fibroscan and Serum Fibrose-marker


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
HIV-infected, hepatitis B and C seronegative Patients With Chronic alanine aminotransferase (ALT) Elevation

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

  Contacts and Locations
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Please refer to this study by its identifier: NCT01208376

University Hospital Zurich
Zurich, Switzerland
Sponsors and Collaborators
Helen Kovari-Kramer
Swiss HIV Cohort Study
Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich
  More Information

Responsible Party: Helen Kovari-Kramer, MD, University of Zurich Identifier: NCT01208376     History of Changes
Other Study ID Numbers: SHCS 625
Study First Received: September 22, 2010
Last Updated: December 19, 2016

Additional relevant MeSH terms:
HIV Infections
Liver Cirrhosis
Pathologic Processes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Liver Diseases
Digestive System Diseases processed this record on May 23, 2017