Prevalence of Liver Fibrosis and Progression of Liver Fibrosis
This study is ongoing, but not recruiting participants.
Sponsor:
Helen Kovari-Kramer
Collaborator:
Swiss HIV Cohort Study
Information provided by (Responsible Party):
Helen Kovari-Kramer, University of Zurich
ClinicalTrials.gov Identifier:
NCT01208376
First received: September 22, 2010
Last updated: May 10, 2016
Last verified: May 2016
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Purpose
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.
| Condition | Intervention |
|---|---|
|
HIV Infection and Chronic Alanine Aminotransferase Elevation |
Other: Fibroscan |
| Study Type: | Observational |
| Study Design: | 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
North American Indian childhood cirrhosis
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
Further study details as provided by University of Zurich:
Primary Outcome Measures:
- Liverfibrosis [ Time Frame: 3 years ] [ Designated as safety issue: No ]
| Enrollment: | 195 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | August 2016 |
| Estimated Primary Completion Date: | August 2016 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
HIV-infected, hepatitis B and C seronegative Patients With Chronic alanine aminotransferase (ALT) Elevation
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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01208376
Please refer to this study by its ClinicalTrials.gov identifier: NCT01208376
Locations
| Switzerland | |
| University Hospital Zurich | |
| Zurich, Switzerland | |
Sponsors and Collaborators
Helen Kovari-Kramer
Swiss HIV Cohort Study
Investigators
| Study Director: | 01 Studienregister MasterAdmins | UniversitaetsSpital Zuerich |
More Information
| Responsible Party: | Helen Kovari-Kramer, MD, University of Zurich |
| ClinicalTrials.gov Identifier: | NCT01208376 History of Changes |
| Other Study ID Numbers: | SHCS 625 |
| Study First Received: | September 22, 2010 |
| Last Updated: | May 10, 2016 |
| Health Authority: | Switzerland: Swissmedic |
Additional relevant MeSH terms:
|
HIV Infections Fibrosis Liver Cirrhosis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Pathologic Processes Liver Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on September 28, 2016