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Prevalence of Liver Fibrosis and Progression of Liver Fibrosis

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01208376
Enrollment
195
Registered
2010-09-23
Start date
2010-10-31
Completion date
2018-08-31
Last updated
2016-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infection and Chronic Alanine Aminotransferase Elevation

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.

Interventions

OTHERFibroscan

Fibroscan and Serum Fibrose-marker

Sponsors

Swiss HIV Cohort Study
CollaboratorNETWORK
Helen Kovari-Kramer
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Liverfibrosis3 years

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026