NCT02306070

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 3, 2014

Completed
1.1 years until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 3, 2018

Completed
Last Updated

April 17, 2018

Status Verified

September 1, 2017

Enrollment Period

1.7 years

First QC Date

November 2, 2014

Last Update Submit

April 13, 2018

Conditions

HIV InfectionHepatitis C

Outcome Measures

Primary Outcomes (1)

  • Change in FibroScan® score (kPa) from baseline to week 12 (start of HCV treatment), compared between treatment groups.

    liver elastography score (kPa)

    12 weeks

Secondary Outcomes (10)

  • Virological response rates (SVR 12 weeks post HCV antiviral therapy) between treatment groups.

    12 weeks

  • Change in APRI measurements from baseline compared between treatment groups.

    12, 24, 48weeks

  • Change from baseline in glucose metabolism (HOMA-IR, fasting insulin, glucose levels)

    4, 8, 12, 24, 36, 48 weeks

  • Changes from baseline in lipid levels

    12, 36, 48 weeks

  • Changes from baseline in anthropometric measures

    4, 8, 12, 24, 36, 48 weeks

  • +5 more secondary outcomes

Study Arms (2)

Metformin + lifestyle modification

EXPERIMENTAL

Metformin + lifestyle modification pre, during and post HCV antiviral therapy

Drug: Metformin

No Metformin + Lifestyle modification

PLACEBO COMPARATOR

No metformin + lifestyle modification pre, during and post HCV antiviral therapy.

Drug: No metformin treatment

Interventions

MetforminDRUG

metformin treatment + standard of care dietary and exercise advice

Also known as: lifestyle modification
Metformin + lifestyle modification
No metformin treatmentDRUG

no metformin treatment + standard of care dietary and exercise advice

Also known as: lifestyle modification
No Metformin + Lifestyle modification

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ottawa Hospital, General Campus

Ottawa, Ontario, Canada

Location

Related Publications (1)

  • Doyle MA, Singer J, Lee T, Muir M, Cooper C. Improving treatment and liver fibrosis outcomes with metformin in HCV-HIV co-infected and HCV mono-infected patients with insulin resistance: study protocol for a randomized controlled trial. Trials. 2016 Jul 20;17(1):331. doi: 10.1186/s13063-016-1454-6.

    PMID: 27439433DERIVED

Related Links

MeSH Terms

Conditions

HIV InfectionsHepatitis C

Interventions

Metformin

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesHepatitis, Viral, HumanFlaviviridae InfectionsHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Curtis Cooper, MD

    The Ottawa Hospital Division of Infectious Diseases

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2014

First Posted

December 3, 2014

Study Start

January 1, 2016

Primary Completion

September 30, 2017

Study Completion

April 3, 2018

Last Updated

April 17, 2018

Record last verified: 2017-09

Locations

CA(1)