We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

Prevalence of Liver Fibrosis and Progression of Liver Fibrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01208376
Recruitment Status : Active, not recruiting
First Posted : September 23, 2010
Last Update Posted : December 20, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
HIV Infection and Chronic Alanine Aminotransferase Elevation Other: Fibroscan

Study Design

Study Type : Observational
Actual Enrollment : 195 participants
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
Study Start Date : October 2010
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. Liverfibrosis [ Time Frame: 3 years ]

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

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): 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
ClinicalTrials.gov Identifier: NCT01208376     History of Changes
Other Study ID Numbers: SHCS 625
First Posted: September 23, 2010    Key Record Dates
Last Update Posted: December 20, 2016
Last Verified: May 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