Study of Combivir for Patients With Primary Biliary Cirrhosis

• Status: Completed
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alberta
• Collaborators: Axcan Pharma; GlaxoSmithKline
• Treatments: Antiviral Agents; Lamivudine, zidovudine drug combination

Criteria

Inclusion Criteria:

• Patients 18 years old of either sex will be recruited for this study.

• Persistently elevated alkaline phosphatase or serum aminotransferases of at least 1.5 times normal after a minimum of 6 months UDCA therapy.

• Positive serum AMA (titer > 1:20).

• Liver biopsy histology compatible with PBC obtained at any time prior to study.

• Maintained on UDCA at a dose of 13-15 mg/kg for 6 or more months.

• Patients must read and sign informed consent form.

Exclusion Criteria:

• Patients treated with immunosuppressive or anti-inflammatory agents such as colchicine, methotrexate, D-penicillamine, cyclosporine, tacrolimus, mycophenolate mofetil, corticosteroid therapy will be excluded but may enter the study after a 3 month period off immunosuppressive and anti-inflammatory therapy.

• Advanced liver disease: Childs Pugh class B or C cirrhosis, recurrent variceal hemorrhage, spontaneous encephalopathy, diuretic resistant ascites, need for liver transplantation within the year.

• Patients with a secondary hepatic diagnosis such as viral hepatitis, drug induced liver injury, extrahepatic biliary obstruction, primary sclerosing cholangitis, metabolic liver diseases or alcoholic liver disease.

• Regular use of more than 30 g of alcohol per day in the last year.

• Patients with a predicted survival of less than 3 years from malignant or other potentially life threatening disease.

• Creatinine clearance less than < 70 mL/min using the Cockcroft Gault equation:

• Clinically apparent pancreatitis.

• Serum amylase > 3 x upper limit of normal (patients with sicca syndrome and salivary gland disease may have elevated amylase levels)

• Pregnancy or breast-feeding a child.

• Sexually active patients of child bearing age and not using effective contraception.

• Allergic reaction to Combivir like drugs

• Clinical evidence of myositis

• Weight of < 50 Kg