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Sponsors and Collaborators: |
University of Alberta GlaxoSmithKline Axcan Pharma |
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Information provided by: | University of Alberta |
ClinicalTrials.gov Identifier: | NCT00490620 |
This is a proof of principal study to determine whether combination anti-viral therapy with Combivir impacts on hepatic biochemistry in patients with primary biliary cirrhosis
Condition | Intervention | Phase |
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Primary Biliary Cirrhosis |
Drug: Combination antiviral therapy Drug: Placebo |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Randomized Controlled Pilot Study of Combivir for Patients With Primary Biliary Cirrhosis |
Enrollment: | 59 |
Study Start Date: | January 2004 |
Study Completion Date: | April 2007 |
Arms | Assigned Interventions |
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1: Placebo Comparator
blinded placebo control
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Drug: Placebo
placebo BID for 6 months
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2: Active Comparator
Antiretroviral therapy
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Drug: Combination antiviral therapy
Zidovudine 300mg and lamivudine 150mg BID for 6 months
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A novel human retrovirus has been cloned from a cDNA library derived from biliary epithelia cells extracted from patients with Primary Biliary Cirrhosis. Although there is no formal proof that this virus is etiologically related to the disease, we have found evidence for viral infection in the majority of patients with PBC using standard serologic and hybridization assays. In order to address the hypotheses that PBC is etiologically related to a retrovirus infection and that anti-retroviral therapy may be beneficial for patients with PBC, we have conducted 2 pilot studies using lamivudine and Combivir (lamivudine 150mg and Zidovudine 300mg). On the whole, little clinical improvement was observed in patients on lamivudine therapy alone, whereas those on Combivir had significant reductions of hepatic biochemistry studies and histologic improvement. Moreover, 4 of 10 Combivir patients completely normalized their liver function tests and the anti-viral therapy was well tolerated. We now propose a larger randomized trial to assess the short term (6 months) safety and efficacy of Combivir for patients with PBC. Efficacy in this study will be defined using both liver biochemistries and virologic endpoints.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Minnesota | |
Mayo Clinic | |
Rochester, Minnesota, United States, 55905 | |
United States, Missouri | |
St Louis University | |
St Louis, Missouri, United States, 63103 | |
Canada, Alberta | |
University of Alberta | |
Edmonton, Alberta, Canada, T5N 1Y9 | |
Canada, Quebec | |
University of Montreal | |
Montreal, Quebec, Canada, H3C 3J7 | |
United Kingdom, England | |
University of Birmingham | |
Birmingham, England, United Kingdom, B15 2TH |
Principal Investigator: | Andrew L Mason, MBBS MRCPI | University of Alberta |
Principal Investigator: | Bruce Bacon, MD | St. Louis University |
Principal Investigator: | Keith Lindor, MD | Mayo Clinic Foundation |
Principal Investigator: | James Neuberger, MD FRCP | University of Birmingham |
Principal Investigator: | Catherine Vincent, MD FRCPC | University of Montreal |
Study ID Numbers: | Col40296 |
Study First Received: | June 21, 2007 |
Last Updated: | October 31, 2007 |
ClinicalTrials.gov Identifier: | NCT00490620 |
Health Authority: | Canada: Health Canada; United States: Food and Drug Administration |
primary biliary cirrhosis C06.552.630.400 retroviral infection C02.782.815 |
Biliary cirrhosis Liver Diseases Fibrosis Cholestasis Lamivudine Zidovudine Liver Cirrhosis |
Cholestasis, Intrahepatic Digestive System Diseases Bile Duct Diseases Biliary Tract Diseases Retroviridae Infections Liver Cirrhosis, Biliary Primary biliary cirrhosis |
Pathologic Processes |