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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
  Purpose

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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: October 2010
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01208376

Contacts
Contact: 01 Studienregister MasterAdmins +41 (0)44 255 11 11

Locations
Switzerland
University Hospital Zurich Recruiting
Zurich, Switzerland
Contact: Helen Kovari Kramer, MD    0041 44 255 11 11    helen.kovari@usz.ch   
Sponsors and Collaborators
Helen Kovari-Kramer
Swiss HIV Cohort Study
Investigators
Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich
  More Information

No publications provided

Responsible Party: Helen Kovari-Kramer, MD, University of Zurich
ClinicalTrials.gov Identifier: NCT01208376     History of Changes
Other Study ID Numbers: SHCS 625
Study First Received: September 22, 2010
Last Updated: December 9, 2014
Health Authority: Switzerland: Swissmedic

ClinicalTrials.gov processed this record on March 03, 2015