Randomized Controlled Pilot Study of Combivir

 

for Patients with Primary Biliary Cirrhosis

 

 

 

Patients are being recruited for this anti-retroviral treatment study. 

The aims are:

 1) To identify a well tolerated and potentially effective anti-retroviral therapy for patients with PBC   maintained on UDCA therapy for more than 6 months.

 2) To determine the virologic response to therapy and assess potential reservoirs for viral infection   after 6 months of therapy.

 

TREATMENT: Combivir vs Placebo with Urso therapy for 6 months and a 6 month follow-up.

 

INCLUSION CRITERIA	EXCLUSION CRITERIA
1. Over 18 – either sex   2. Persistently elevated alkaline phosphatase    of at least 1.5 times normal after a    minimum of 6 months UDCA therapy.   3. Positive serum AMA (titer > 1:20) – any time prior to study.   4. Liver biopsy histology compatible with PBC    obtained – any time prior to study.   5. Maintained on UDCA or a dose of 13 – 15    mg/kg for 6 months or more.	1. Standard trial exclusion criteria and    pancreatitis.   2. Patients waiting for transplants and    evidence of decompensated liver disease.   3. Use of immunosuppression, colchicine, or    methotrexate within the last 6 months.

 

The study is being conducted in The USA, UK and Canada

Andrew Mason	University of Alberta, 8215 - 112th Street, Edmonton, Alberta, Canada, T6G 2C8
Keith Lindor	Mayo Clinic Foundation, 200 First St SW, Rochester, MN 55905
Bruce Bacon	St. Louis University, 3635 Vista Blvd., St. Louis, MO 63110
John Vierling	Cedars Sinai/UCLA Medical Center, Los Angeles, CA
James Neuberger	Queen Elizabeth Medical Center, Edgbaston, Birmingham B15 2TH, UK

  

For more information please contact:

Dr. Andrew Mason, E-mail: andrew.mason@ualberta.ca or one of the other study physicians