Improving Fibrosis Outcomes With Metformin

• Status: Withdrawn
• Trial end date: 2018-04-03
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ottawa Hospital Research Institute
• Collaborator: CIHR Canadian HIV Trials Network
• Treatments: Metformin

Criteria

Inclusion Criteria:

1. Male or female, 18 to 79 years old inclusive

2. Provision of informed consent

3. Documented history of chronic HCV RNA infection

4. Intending to start on any 8-12 week IFN-free HCV antiviral therapy

5. If HIV-infected and not on HIV antiretroviral therapy, a CD4 count at least > 200

6. Insulin resistance as determined by a HOMA-IR of > 2.0 at screening

7. Evidence of fibrosis on FibroScan® > 8.0 kPa, OR liver biopsy score > 2 (Batts-Ludwig System) [55] (within 2 years)

Exclusion Criteria:

1. Pregnant, suspected to be pregnant, planning to become pregnant or breastfeeding

2. Chronic HBV infection

3. HbA1c > 8.0

4. Use of immune suppressing medications

5. Active malignancy

6. Current or any previous treatment with Metformin, other oral diabetes medications,insulin

7. Pre-existing diabetes (type 1, type 2 or gestational diabetes)

8. Clinical evidence of decompensated cirrhosis (ascites, esophageal varices, hepatic encephalopathy, hepatocellular carcinoma)

9. 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))

10. History of congestive heart failure requiring pharmacologic therapy

11. Wilson's disease

12. Alpha-1 antitrypsin

13. Hemochromatosis

14. Biliary Cirrhosis

15. Alcohol consumption > 50 g / day on average (see Appendix B for conversion to volume)

16. Participation in other clinical investigations during the study

17. 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.