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Prevalence of Liver Fibrosis and Progression of Liver Fibrosis

NCT ID: NCT01208376

Last Updated: 2016-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

195 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-10-31

Study Completion Date

2018-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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HIV Infection and Chronic Alanine Aminotransferase Elevation

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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unexplained chronic ALT elevation

Case patients: HIV-infected, unexplained chronic alanine aminotransferase (ALT) elevation

Fibroscan

Intervention Type OTHER

Fibroscan and Serum Fibrose-marker

always normal ALT

Control patients: HIV-infected, always normal ALT values

Fibroscan

Intervention Type OTHER

Fibroscan and Serum Fibrose-marker

Interventions

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Fibroscan

Fibroscan and Serum Fibrose-marker

Intervention Type OTHER

Other Intervention Names

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Fibroscan and Serum Fibrose-marker

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Swiss HIV Cohort Study

NETWORK

Sponsor Role collaborator

Helen Kovari-Kramer

OTHER

Sponsor Role lead

Responsible Party

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Helen Kovari-Kramer

MD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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01 Studienregister MasterAdmins

Role: STUDY_DIRECTOR

UniversitaetsSpital Zuerich

Locations

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University Hospital Zurich

Zurich, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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SHCS 625

Identifier Type: -

Identifier Source: org_study_id