Prevalence of Liver Fibrosis and Progression of Liver Fibrosis
This study is not yet open for participant recruitment.
Verified September 2010 by University of Zurich
Sponsor:
University of Zurich
Collaborator:
Swiss HIV Cohort Study
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
NCT01208376
First received: September 22, 2010
Last updated: September 27, 2010
Last verified: September 2010
| Tracking Information | |||||
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| First Received Date ICMJE | September 22, 2010 | ||||
| Last Updated Date | September 27, 2010 | ||||
| Start Date ICMJE | October 2010 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT01208376 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Prevalence of Liver Fibrosis and Progression of Liver Fibrosis | ||||
| Official Title ICMJE | 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 | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | HIV-infected, hepatitis B and C seronegative Patients With Chronic alanine aminotransferase (ALT) Elevation |
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| Condition ICMJE | HIV Infection and Chronic Alanine Aminotransferase Elevation | ||||
| Intervention ICMJE | Other: Fibroscan
Fibroscan and Serum Fibrose-marker
Other Name: Fibroscan and Serum Fibrose-marker |
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| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Not yet recruiting | ||||
| Estimated Enrollment ICMJE | 200 | ||||
| Completion Date | October 2014 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion criteria: Case patients:
Control patients:
Exclusion criteria: please see inclusion criteria |
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Switzerland | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01208376 | ||||
| Other Study ID Numbers ICMJE | SHCS 625 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Kovari Kramer Helen, MD, University Hospital Zurich, Division of Infectious Diseases | ||||
| Study Sponsor ICMJE | University of Zurich | ||||
| Collaborators ICMJE | Swiss HIV Cohort Study | ||||
| Investigators ICMJE |
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| Information Provided By | University of Zurich | ||||
| Verification Date | September 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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