Recruiting

Antiviral Medication

Sponsor:

University Health Network, Toronto

Code:

NCT00188201

Conditions

Hepatitis C

Hepatitis B

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Study Details

Brief summary:

The estimated global prevalence of hepatitis C (HCV) infection is approximately 3% (170 million individuals). In Canada there are an estimated 240,000 people infected with HCV. The current study addresses the hypothesis that neurocognitive and neurochemical abnormalities may occur in individuals with HCV-infection who do not have liver cirrhosis or vasculitic neuropathy, and this may result from a direct effect of HCV on the Central Nervous System (CNS). The purpose of this study is to assess whether infection with the Hepatitis-C virus is associated with changes in thinking skills and brain chemistry, in patients who do not have liver cirrhosis. In addition, we are examining whether such changes in thinking skills and brain chemistry are reversed by antiviral treatment. We are also studying whether factors such as fatigue and depression have an effect on thinking skills in people with Hepatitis-C. In order to take into account the impact of having viral hepatitis, we will be comparing the results of the Hepatitis-C group to the results of a group of patients with Hepatitis-B, and to a group of individuals who do not have Hepatitis.

Conditions

Hepatitis C

Hepatitis B

Study ID

NCT00188201

Start date

Jan, 2002

Status verified date

Sep, 2005

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Inclusion Criteria:

  • patients attending Liver Clinic at Toronto Western Hospital, Toronto, ON, Canada
  • Fluent in English
  • Men and women between the ages of 18 and 65
  • Subjects must provide written informed consent to participate
  • Control subjects: negative for both HBV, HCV, and HIV

Additional Inclusion Criteria For HCV and HBV patients:

  • patient is a candidate for antiviral treatment
  • non-cirrhotic as determined by recent liver biopsy (<2 years prior to assessment)
  • HCV subjects: positive for HCV RNA, negative for HBV and HIV
  • HBV subjects: positive for HBV RNA and negative for HCV and HIV

Exclusion Criteria:

presence of any of the following medical conditions:

  • Thyroid dysfunction, or other endocrine disorder
  • Major psychiatric disease, especially major depression and bipolar disorder
  • Vitamin B12 or folate deficiency
  • Unstable cardiovascular disease (especially atrial fibrillation)
  • Unstable diabetes
  • Haemophilia (depending on frequency of medication usage)
  • The presence of other viral infections (HIV; syphilis)
  • Use of pharmaceuticals known to affect cognitive function
  • Current alcohol use greater than 2 units per day, or prior history of alcoholism
  • Use of illicit drugs within 2 years, or prior prolonged history
  • History of intravenous drug use within the past 5 years
  • History of any of the following neurological conditions: head injury with loss of consciousness greater than 30min., history of stroke, dementia, seizure disorder,recent substance abuse disorder (within 2 years), learning disability
  • Postmenopausal and perimenopausal female participants, unless hormone replacement therapy has been administered consistently for 2 years (on the basis that they may have concentration and memory dysfunction related to cholinergic deficits)

Study Design

Enrollment

150 participants

Interventions and Outcome Measures

Central Contacts and Locations

Central contacts

Mirela Mrkonjic

416-603-5800

Locations

Liver Clinic, Toronto Western Hospital, UHN.

Recruiting

Toronto, Ontario, Canada, M5T 2S8

Contacts

E.J.L. (Jenny) Heathcote, MD

416-603-5914

Principal Investigator:

E.J.L (Jenny) Heathcote, M.D.

More Information

Sponsor

University Health Network, Toronto

Last update posted

Nov 29, 2005

Last verified

Sep, 2005

Keywords

  • Hepatitis C
  • neucognitive functions
  • neuropsychological testing
  • antiviral treatment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2005-11-29.