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Prevalence of Liver Fibrosis and Progression of Liver Fibrosis

H

Helen Kovari-Kramer

Status

Unknown

Conditions

HIV Infection and Chronic Alanine Aminotransferase Elevation

Treatments

Other: Fibroscan

Study type

Observational

Funder types

Other
NETWORK

Identifiers

NCT01208376
SHCS 625

Details and patient eligibility

About

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.

Enrollment

195 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

195 participants in 2 patient groups

unexplained chronic ALT elevation
Description:
Case patients: HIV-infected, unexplained chronic alanine aminotransferase (ALT) elevation
Treatment:
Other: Fibroscan
always normal ALT
Description:
Control patients: HIV-infected, always normal ALT values
Treatment:
Other: Fibroscan

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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