Prevalence of Liver Fibrosis and Progression of Liver Fibrosis

This study is ongoing, but not recruiting participants.

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 19, 2016

Last verified: May 2016

History of Changes

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:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by Helen Kovari-Kramer, 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

Eligibility


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

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

Locations


Switzerland
University Hospital Zurich
Zurich, Switzerland

Sponsors and Collaborators

Helen Kovari-Kramer

Swiss HIV Cohort Study

Investigators


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
Study First Received:	September 22, 2010
Last Updated:	December 19, 2016

Additional relevant MeSH terms:


Fibrosis 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

ClinicalTrials.gov processed this record on June 23, 2017

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