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HIV InfectionPhase 2NCT02306070

Improving Fibrosis Outcomes With Metformin

A Phase 2 study testing Metformin and No metformin treatment in people with HIV Infection and Hepatitis C, run by Ottawa Hospital Research Institute at 1 site in Canada.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 79 years
Conditions the study is for
HIV Infection, Hepatitis C
What is being tested?
Metformin and No metformin treatment
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
1 siteCanada
Study dates
Jan 2016to 3 Apr 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 19Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • The Ottawa Hospital, General Campus

    Ottawa, Ontario

Other trials in Canada

About this study

Official title: Improving Treatment and Liver Fibrosis Outcomes With Metformin in HCV-HIV Co-infected and HCV Mono-infected Patients With Insulin Resistance.

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.

Read the 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 SVR is variable and predictors of regression are not well established. In addition, achieving SVR in patients with cirrhosis does not necessarily prevent decompensation or eliminate the risk of HCC. A better understanding of the role insulin resistance and impaired glucose metabolism have on these outcomes in HCV patients who achieve SVR are needed.

Identifying and targeting potentially modifiable risk factors such as IR may be of significant importance in preventing progression of and promoting regression of liver fibrosis, reducing mortality and improving outcomes for HCV-HIV co-infected and HCV-mono-infected patients.

This proposed pilot study will be the first to evaluate the role of Metformin on liver fibrosis in HCV-HIV co-infected and HCV mono-infected patients with IR receiving DAA HCV treatment.

If Metformin is effective in reducing liver fibrosis in this patient population, this will represent a well-tolerated, easy to administer, inexpensive therapy that will protect against negative HCV outcomes. This study will also be an opportunity to evaluate the impact of insulin resistance and hyperglycemia have on viral clearance HCV-infected patients treated with interferon-free regimens. In addition, the study will further explore the relationship between HCV, insulin resistance and AFP levels.

Being tested
Metformin, No metformin treatment
Medical subject headings
HIV Infections, Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MetforminDrug

    Also called lifestyle modification

    metformin treatment + standard of care dietary and exercise advice

  • No metformin treatmentDrug

    Also called lifestyle modification

    no metformin treatment + standard of care dietary and exercise advice

Study groups in NCT02306070
Study groupRoleWhat they receive
Metformin + lifestyle modificationExperimentalMetformin + lifestyle modification pre, during and post HCV antiviral therapy
Receives: Drug: Metformin
No Metformin + Lifestyle modificationPlacebo comparatorNo metformin + lifestyle modification pre, during and post HCV antiviral therapy.
Receives: Drug: No metformin treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    liver elastography score (kPa)

    Measured: 12 weeks

Secondary outcomes (10)

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

    HCV RNA level (IU/mL)

    Measured: 12 weeks

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

    calculated APRI

    Measured: 12, 24, 48weeks

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

    fasting glucose and insulin

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

  4. Changes from baseline in lipid levels

    fasting total cholesterol, LDL-c, HDL-c, triglycerides

    Measured: 12, 36, 48 weeks

  5. Changes from baseline in anthropometric measures

    waist circumference, body weight and BMI

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

  6. Changes from baseline in liver-related inflammatory markers

    IL-6, IL-8, TNF-alpha, TGF-beta, C-reactive protein

    Measured: 4, 8, 12, 24, 36 weeks

  7. Changes in AFP levels from baseline

    AFP

    Measured: 12, 24, 36, 48 weeks

  8. Participant acceptability to study medication dosing (in Arm 1 only)

    Participant acceptability will be evaluated in Arm 1 only using the Treatment Satisfaction Questionnaire for Medication (TSQM), Version 1.4

    Measured: 8, 24, 48 weeks

  9. Changes from baseline in diet

    Changes in diet from baseline will be captured using the International Physical Activity Questionnaire short-form (IPAQ-sf)

    Measured: 24, 48 weeks

  10. Changes from baseline in physical exercise parameters

    Changes in physical activity from baseline will be captured using the International Physical Activity Questionnaire short-form (IPAQ-sf)

    Measured: 24, 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2014 (estimated)
  2. Study startJan 2016
  3. Primary completion30 Sep 2017
  4. Study completion3 Apr 2018 (estimated)

Why it stopped: insufficient funding

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02306070
Sponsor's protocol ID
CTNPT 019
Status last verified
Sep 2017
First submitted
2 Nov 2014
Last updated
17 Apr 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 27439433

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Metformin and No metformin treatment in people with HIV Infection and Hepatitis C, run by Ottawa Hospital Research Institute at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 17 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in FibroScan® score (kPa) from baseline to week 12 (start of HCV treatment), compared between treatment groups. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02306070, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2018.

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