Status:
WITHDRAWN
Improving Fibrosis Outcomes With Metformin
Lead Sponsor:
Ottawa Hospital Research Institute
Collaborating Sponsors:
CIHR Canadian HIV Trials Network
Conditions:
HIV Infection
Hepatitis C
Eligibility:
All Genders
18-79 years
Phase:
PHASE2
Brief Summary
This study will evaluate the role of Metformin on liver fibrosis in HCV-HIV co-infected and HCV mono-infected patients with insulin resistance receiving DAA HCV treatment.
Detailed Description
HCV antiviral therapy has evolved rapidly in recent years and access to these medications has improved. While SVR is associated with improved liver outcomes, the rate of liver fibrosis regression with...
Eligibility Criteria
Inclusion
- Male or female, 18 to 79 years old inclusive
- Provision of informed consent
- Documented history of chronic HCV RNA infection
- Intending to start on any 8-12 week IFN-free HCV antiviral therapy
- If HIV-infected and not on HIV antiretroviral therapy, a CD4 count at least \> 200
- Insulin resistance as determined by a HOMA-IR of \> 2.0 at screening
- Evidence of fibrosis on FibroScan® \> 8.0 kPa, OR liver biopsy score \> 2 (Batts-Ludwig System) \[55\] (within 2 years)
Exclusion
- Pregnant, suspected to be pregnant, planning to become pregnant or breastfeeding
- Chronic HBV infection
- HbA1c \> 8.0
- Use of immune suppressing medications
- Active malignancy
- Current or any previous treatment with Metformin, other oral diabetes medications,insulin
- Pre-existing diabetes (type 1, type 2 or gestational diabetes)
- Clinical evidence of decompensated cirrhosis (ascites, esophageal varices, hepatic encephalopathy, hepatocellular carcinoma)
- Presence of renal impairment or when renal function is not known, and also in patients with serum creatinine levels above upper limit of normal range. Renal disease or renal dysfunction (e.g., as suggested by serum creatinine levels \>= 136 umol/L (males), \>= 124 umol/L (females) or abnormal creatinine clearance (60 mL/min))
- History of congestive heart failure requiring pharmacologic therapy
- Wilson's disease
- Alpha-1 antitrypsin
- Hemochromatosis
- Biliary Cirrhosis
- Alcohol consumption \> 50 g / day on average (see Appendix B for conversion to volume)
- Participation in other clinical investigations during the study
- History of lactic acidosis, irrespective of precipitating factors
- Active illicit drug use and stable health illness will not be exclusionary assuming it is unlikely to compromise study adherence to protocol and study drug. In HIV-infected participants, HIV antiretroviral use and suppressed HIV viral load will not be required for participation.
- HCV antiviral therapy will not be withheld for any participant that is eligible and desires to start treatment. If HCV treatment is anticipated to be started during the 48-week period of assessment, then participants will not be enrolled.
Key Trial Info
Start Date :
January 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 3 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02306070
Start Date
January 1 2016
End Date
April 3 2018
Last Update
April 17 2018
Active Locations (1)
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1
The Ottawa Hospital, General Campus
Ottawa, Ontario, Canada