Status:
COMPLETED
THISTLE - The HIV-HCV Silibinin Trial
Lead Sponsor:
University of Zurich
Conditions:
HIV
Hepatitis C
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Chronic hepatitis C virus (HCV) is a major cause of morbidity and mortality worldwide with an estimated number of 180 million infected patients. Until 2012 the current standard of care (SOC) treatment...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Age greater or equal 18 years
- HIV-HCV co-infection
- HCV Genotype 1 infection
- At least one liver biopsy since diagnosis of HCV-infection
- Fibrosis score METAVIR = 2 documented by biopsy OR a stiffness greater or equal 7.0 kPa documented by fibroscan during the previous 12 months.
- Documented previous null-response or partial-response to SOC
- Exclusion criteria:
- Contraindications to the study drug under study, e.g. known hypersensitivity or allergy to any ingredient of the study drug
- Patients in need of ART with HIV virological failure (= 400 copies/ml) in the last 3 months
Exclusion
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2014
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01816490
Start Date
April 1 2013
End Date
December 1 2014
Last Update
March 5 2015
Active Locations (1)
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1
Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich
Zurich, Switzerland, 8091