Highly Active Antiretroviral Therapy for Patients With Primary Biliary Cirrhosis
Status:
Completed
Trial end date:
2015-08-01
Target enrollment:
Participant gender:
Summary
Patients with primary biliary cirrhosis (PBC) develop progressive liver disease and often
require liver transplantation. The cause of disease is unknown. It is thought to occur as a
result of an infection in subjects that are more susceptible to disease than others. The
investigators found evidence of retrovirus infection in patients with primary biliary
cirrhosis. The investigators found that most patients with PBC have evidence of viral
infection. Since then the investigators have conducted clinical studies using anti-viral
therapy. The investigators found that PBC patients treated with combination anti-retrovirus
therapy experienced significant reversal of the disease process. However, the changes were
not substantial and the investigators are now looking for better antiviral regimens. Now the
investigators have found a mouse model with a similar virus infection that develops a similar
biliary disease. Importantly, the investigators found that antiviral therapy blocks the
development of the disease in this mouse. The investigators have used this model to find
safer and more effective antiviral treatments for patients with PBC. The investigators have
now found out that a combination of highly active antiretroviral therapy with Truvada and
Kaletra stops disease in the mouse and plan to use this combination to see if it works in
patients with PBC.
Phase:
N/A
Details
Lead Sponsor:
University of Alberta
Collaborators:
Abbott Canadian Institutes of Health Research (CIHR) Gilead Sciences
Treatments:
Emtricitabine Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination Lopinavir Ritonavir Tenofovir