Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of Arizona
With
Emory University
National Center for Complementary and Integrative Health (NCCIH)
Age
21–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Age 21-65 years including males, females and minorities
Ability to speak and read remedial English
Serum positive for either anti-HCV antibodies or HCV-RNA positive by PCR
Compensated liver disease with the following minimum hematologic and biochemical criteria: hemoglobin ≥13 g/dl for males; ≥12 g/dl for females, white blood cell count \> 3,000/mm3, neutrophil count \>1,5000/mm3, platelets \> 100,000/mm3, prothrombin time ≤ 2 seconds prolonged compared to control, or equivalent INR ratio, albumin stable and within normal limits, serum creatinine within normal limits, thyroid-stimulating hormone within normal limits, direct bilirubin ≤ 0.3 mg/dl or within 20% of upper limit of normal (ULN) for local laboratory, indirect bilirubin ≤ 0.8 mg/dl or within 20% of ULN for local laboratory, fasting blood sugar ≤ 115 mg/dl or within 20% of ULN for non-diabetic patients
Negative pregnancy test for women of childbearing potential, and confirmation and documentation that adequate contraception or monogamous relationship with a male partner who has had a vasectomy during the treatment period and for 6 months after discontinuation of therapy
Not breastfeeding
Documentation and confirmation of adequate contraception in sexually active males
Free from all psychotropic medications for 14 days prior to baseline visit (8 weeks for fluoxetine)
You may not be if
Evidence of untreated or poorly controlled endocrine, cardiovascular, hematological, renal, or neurological disease
Evidence of decompensated liver disease (such as a history or presence of ascites, bleeding varices, spontaneous encephalopathy)
History of narcolepsy, PLMS or sleep apnea (or documented during the adaptation night)
History of CNS trauma or active seizure disorder requiring medication
Any cause for liver disease other than chronic hepatitis C, such as co-infection with hepatitis B virus and/or human immunodeficiency virus, hemochromatosis, or Wilson's diseases
Prior treatment with ribavirin or other antiviral or immunomodulatory drugs, including corticosteroids within 6 months of entry into protocol
Chronic use of agents known to affect monoamine metabolism/function (and hence potentially affect the TSST), including, but not limited to, alpha- and beta-receptor agonists and antagonists, methylphenidate hydrochloride, dextroamphetamine, midodrine hydrochloride, theophylline, ephedrine, systemic antifungal azoles, sumatriptan succinate
Psychotropic medications within 14 days prior to baseline visit (8 weeks for fluoxetine)
Clinical gout
Hypersensitivity to alpha interferon or ribavirin
Hemoglobinopathies (e.g. thalassemia)
A positive pregnancy test
Organ transplants
A score of \<24 on the Mini Mental Status Exam (MMSE)
Active, effective treatment of depression with an antidepressant within the past six months
Actively meet criteria for major depression within the past six months
Meet criteria for schizophrenia or bipolar disorder (mania) past or present
Active abuse of alcohol or illicit/prescription drugs within the past year any other condition which in the opinion of the investigator would make the patient unsuitable for enrollment, or could interfere with participating in or completing the protocol
