Prevalence of Liver Fibrosis and Progression of Liver Fibrosis

HIV Infection and Chronic Alanine Aminotransferase Elevation Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01208376
• Other study ID #: SHCS 625
• Status: Active, not recruiting
• Phase: N/A
• First received: September 22, 2010
• Last updated: December 19, 2016
• Start date: October 2010
• Est. completion date: August 2018

Study information

• Verified date: May 2016
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 195
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Fibrosis
• HIV Infection and Chronic Alanine Aminotransferase Elevation
• HIV Infections
• Liver Cirrhosis

Intervention

Other:
• Fibroscan
Fibroscan and Serum Fibrose-marker

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
Helen Kovari-Kramer	Swiss HIV Cohort Study

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Liverfibrosis		3 years	No