Ignite Creation Date:
2024-05-05 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00490620
Status:
COMPLETED
Last Update Posted:
2007-11-01
First Post:
2007-06-21
Brief Title:
Study of Combivir for Patients With Primary Biliary Cirrhosis
Sponsor:
University of Alberta
Organization:
University of Alberta
Study Overview
Official Title:
Randomized Controlled Pilot Study of Combivir for Patients With Primary Biliary Cirrhosis
Status:
COMPLETED
Status Verified Date:
2007-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None