Prevalence of Liver Fibrosis and Progression of Liver Fibrosis
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ClinicalTrials.gov Identifier: NCT01208376 |
Recruitment Status
:
Active, not recruiting
First Posted
: September 23, 2010
Last Update Posted
: December 20, 2016
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Condition or disease | Intervention/treatment |
---|---|
HIV Infection and Chronic Alanine Aminotransferase Elevation | Other: Fibroscan |
Study Type : | Observational |
Actual Enrollment : | 195 participants |
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 |
Study Start Date : | October 2010 |
Estimated Primary Completion Date : | August 2018 |
Estimated Study Completion Date : | August 2018 |

Group/Cohort | Intervention/treatment |
---|---|
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
|
- Liverfibrosis [ Time Frame: 3 years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01208376
Switzerland | |
University Hospital Zurich | |
Zurich, Switzerland |
Study Director: | 01 Studienregister MasterAdmins | UniversitaetsSpital Zuerich |
Responsible Party: | Helen Kovari-Kramer, MD, University of Zurich |
ClinicalTrials.gov Identifier: | NCT01208376 History of Changes |
Other Study ID Numbers: |
SHCS 625 |
First Posted: | September 23, 2010 Key Record Dates |
Last Update Posted: | December 20, 2016 |
Last Verified: | May 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 |