Highly Active Antiretroviral Therapy for Patients With Primary Biliary Cirrhosis (HAART)
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ClinicalTrials.gov Identifier: NCT01614405 |
Recruitment Status
:
Completed
First Posted
: June 7, 2012
Last Update Posted
: December 2, 2015
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Condition or disease | Intervention/treatment | Phase |
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Primary Biliary Cirrhosis | Drug: Truvada and Kaletra | Not Applicable |
6 months therapy with blinded Kaletra and Truvada vs. 6 months therapy with blinded placebo followed by 6 months open label therapy with Kaletra and Truvada
18 month extension study with open label Kaletra and Truvada in patients completing 6 months of therapy with Kaletra and Truvada with biochemical endpoint
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 13 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Randomized Controlled Pilot Study of Highly Active Anti-Retroviral Therapy for Patients With Primary Biliary Cirrhosis |
Study Start Date : | June 2012 |
Actual Primary Completion Date : | July 2015 |
Actual Study Completion Date : | August 2015 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo
6 months therapy with blinded placebo followed by 6 months open label therapy with Kaletra and Truvada. Then there is an option for an 18 month follow-up study.
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Drug: Truvada and Kaletra
one tablet of Truvada a day at standard dose of Tenofovir 300mg and Emtricitabine 200mg and four tablets of Kaletra once a day for a total dose of lopinavir 800mg and ritonavir 200mg for 6 months or less if adverse events occur
Other Names:
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Active Comparator: Truvada and Kaletra
Patients will be take Truvada and Kaletra for 6 months with the option of open label for additional 18 months.
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Drug: Truvada and Kaletra
one tablet of Truvada a day at standard dose of Tenofovir 300mg and Emtricitabine 200mg and four tablets of Kaletra once a day for a total dose of lopinavir 800mg and ritonavir 200mg for 6 months or less if adverse events occur
Other Names:
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- 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 ]
- normalization of bilirubin. [ Time Frame: The outcomes will be measured are from 12 to 24 weeks at the end of the 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 ]
- 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 ]
- 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 ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients 18 years old of either sex will be recruited for this study.
- Elevated ALP after 6 months UDCA therapy ≥ 2 x upper limit of normal or abnormal bilirubin.
- Positive serum AMA or Liver biopsy histology compatible with PBC.
- 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:
- Subjects with baseline AST or ALT > 5 x ULN.
- 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.
- 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.
- 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.
- An ultrasound showing a hepatic mass consistent with hepatocellular carcinoma within the last year in patients with cirrhosis.
- Previous allergic reaction to study medications.
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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
- Pregnancy or breast-feeding a child. Young sexually active patients not using contraception
- Young sexually active patients not using contraception.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01614405
Canada, Alberta | |
University of Alberta | |
Edmonton, Alberta, Canada, T6G 2B2 |
Principal Investigator: | Andrew Mason | University of Alberta |
Publications:
Responsible Party: | Andrew L. Mason, Principal Investigator, University of Alberta |
ClinicalTrials.gov Identifier: | NCT01614405 History of Changes |
Other Study ID Numbers: |
HAART Study |
First Posted: | June 7, 2012 Key Record Dates |
Last Update Posted: | December 2, 2015 |
Last Verified: | December 2014 |
Keywords provided by Andrew L. Mason, University of Alberta:
PBC |
Additional relevant MeSH terms:
Fibrosis Liver Cirrhosis Liver Cirrhosis, Biliary Pathologic Processes Liver Diseases Digestive System Diseases Cholestasis, Intrahepatic Cholestasis Bile Duct Diseases Biliary Tract Diseases Ritonavir Lopinavir Tenofovir Emtricitabine |
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors |