Highly Active Antiretroviral Therapy for Patients With Primary Biliary Cirrhosis

• Register: ClinicalTrials.gov
• Last refreshed on: 14 December 2015
• Main ID: NCT01614405
• Date of registration: 25/04/2011
• Prospective Registration: Yes
• Primary sponsor: University of Alberta
• Public title: Highly Active Antiretroviral Therapy for Patients With Primary Biliary Cirrhosis HAART
• Scientific title: Randomized Controlled Pilot Study of Highly Active Anti-Retroviral Therapy for Patients With Primary Biliary Cirrhosis
• Date of first enrolment: June 2012
• Target sample size: 13
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01614405
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Canada

Contacts

• Name: Andrew Mason
• Affiliation: University of Alberta

Key inclusion & exclusion criteria

Inclusion Criteria:

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

2. Elevated ALP after 6 months UDCA therapy = 2 x upper limit of normal or abnormal
bilirubin.

3. Positive serum AMA or Liver biopsy histology compatible with PBC.

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

5. Patients must read and sign informed consent form

Exclusion Criteria:

1. Subjects with baseline AST or ALT > 5 x ULN.

2. Patients who have altered dose of any medications used to treat PBC (such as UDCA) or
the use of colchicine, corticosteroids, azathioprine, chlorambucil, methotrexate, or
D-penicillamine within the last 6 months.

3. Advanced liver disease or esophageal varices, INR > 1.2 (upper limit of normal),
Albumin < 35 g/L (lower limit of normal), platelets < 120,000/mm3, Childs Pugh class
B or C cirrhosis, presence of varices or previous variceal hemorrhage, spontaneous
encephalopathy, ascites or need for liver transplantation.

4. Patients with a secondary diagnosis such as HIV, 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. Clinically apparent pancreatitis or with a predicted
survival of less than 3 years from malignant or other potentially life threatening
disease.

5. An ultrasound showing a hepatic mass consistent with hepatocellular carcinoma within
the last year in patients with cirrhosis.

6. Previous allergic reaction to study medications.

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

Creatinine clearance (mL/min) = (140 - age) x body wt (Kg) x 0.85 (if female)/serum
creatinine in mol/l

8. Pregnancy or breast-feeding a child. Young sexually active patients not using
contraception

9. Young sexually active patients not using contraception.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Primary Biliary Cirrhosis

Intervention(s)

Drug: Truvada and Kaletra

Primary Outcome(s)

normalization of bilirubin. [Time Frame: The outcomes will be measured are from 12 to 24 weeks at the end of the study]

Reduction of ALP to 1.67x ULN [Time Frame: The outcomes will be measured are from 12 to 24 weeks at the end of the study]

Secondary Outcome(s)

Changes in AMA and immunoglobulin levels [Time Frame: The outcomes will be measured are from 12 to 24 weeks in RCT; and 6 monthly to 2 years for the extension study]

Symptoms with changes in PBC-40 [Time Frame: The outcomes will be measured are from 12 to 24 weeks in RCT; and 6 monthly to 2 years for the extension study]

Reduction of human betaretrovirus. [Time Frame: The outcomes will be measured are from 12 to 24 weeks in RCT; and 6 monthly to 2 years for the extension study]

Biochemistry: GGT, AST and ALT [Time Frame: The outcomes will be measured are from 12 to 24 weeks in RCT; and 6 monthly to 2 years for the extension study]

Histology in extension study [Time Frame: The outcomes will be measured are from 12 to 24 weeks in RCT; and 6 monthly to 2 years for the extension study]

Secondary ID(s)

HAART Study

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Canadian Institutes of Health Research (CIHR)

Abbott

Gilead Sciences