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Hepatitis C Antiviral Resistance in African-Americans (only for HIV- patients)
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Sponsored by
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Purpose
This study is designed to test the hypothesis that African-Americans respond
less well to combination pegylated interferon and ribavirin therapy than
Caucasian-Americans who have chronic hepatitis C genotype 1 and who were not
previously treated with either interferon or ribavirin. Reasons for
differences in response, regardless of race, will be studied.
Condition Treatment or Intervention
Hepatitis C
Drugs: Pegasys pegylated interferon plus ribavirin
Phase III Study
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single
Group Assignment, Efficacy Study
Official Title: Study of Viral Resistance to Antiviral Therapy of Chronic
Hepatitis C (Virahep-C)
Eligibility
Ages Eligible for Study: 18 Years - 70 Years, Genders Eligible for
Study: Both
Criteria
Inclusion:
- Age between 18 and 70 years at screening
- Black/African American or White/Caucasian Born in the United States
- Quantifiable Serum HCV RNA
- Hepatitis C genotype 1
- Liver biopsy consistent with chronic hepatitis C
- Negative urine pregnancy test
- Males and Females must be using two reliable forms of effective
contraception while on drug and during follow-up.
Exclusion:
- Previous treatment with interferon or ribavirin
- Positive test at screening for anti-HIV
- Positive test for HBsAg
- Alcohol consumption of more than two drinks/day
- History of other chronic liver disease
- Pregnant or breast-feeding women
- Male partners of women who are pregnant or contemplating pregnancy
- Neutrophil count <1000 cells/mm3
- Hgb <11 g/dl in women or 12 g/dl in men
- Platelet count <75, 000 cells/mm3.
- Thalassemia, spherocytosis, history of GI bleeding or those at increased
risk of anemia
- Serum creatinine level >1.5 times the upper limitof normal at screening
or CrCl < 75cc/min,
- Current dialysis
- Alcohol or drug abuse within 6 months
- History of poorly controlled psychiatric disease, especially depression
- History of immunologically mediated disease
- Decompensated liver disease
- High risk cardiovascular/coronary artery disease
- Severe seizure disorder or anticonvulsant use
- Solid organ or bone marrow transplantation
- Thyroid disease poorly controlled on prescribed medications
- History or other evidence of retinopathy
- Chronic use of oral steroids
- Inability or unwillingness to provide informed consent or abide by the
study protocol
Expected Total Enrollment: 400
Location and Contact Information
California
University of California, San Francisco, San Francisco, California,
94143, United States
Melissa Gast, BA 415-502-8612 gastm@itsa.ucsf.edu
Norah Terrault, MD, MPH, Principal Investigator
Florida
University of Miami School of Medicine, Miami, Florida, 33136, United
States
Carol Hermitt, MD 305-243-2331 chermitt@med.miami.edu
Lennox J Jeffers, MD, Principal Investigator
Illinois
University of Illinois, Chicago, Chicago, Illinois, 60612, United States
Mary Kozlowski, RN 312-413-5694 makozlowski@uic.edu
Thelma E Wiley, MD, Principal Investigator
Maryland
University of Maryland School of Medicine, Baltimore, Maryland, 21201,
United States
Jane Lewis, RN 410-706-8829 jlewis@medicine.umaryland.edu
Charles D Howell, MD, Principal Investigator
Massachusetts
Beth Israel Deaconess Medical Center, Boston, Massachusetts, 02215,
United States
Christine O'Connor, LPN 617-632-1073 coconno2@caregroup.harvard.edu
Nezam Afdhal, MD, Principal Investigator
Michigan
University of Michigan Medical Center, Ann Arbor, Michigan, 48109,
United States
Donna Harsh 734-647-3635 dharsh@med.umich.edu
Hari S Conjeevaram, MD, Principal Investigator
New York
New York-Presbyterian Medical Center, New York, New York, 10032, United
States
Melissa J Brown, MPH 212-305-3839 mjb33@columbia.edu
Robert S Brown, Jr, MD, MPH, Principal Investigator
North Carolina
University of North Carolina, Chapel Hill, North Carolina, 27599,
United States
Paris E Heidt-Davis 919-843-5936 paris_davis@med.unc.edu
Michael W Fried, MD, Principal Investigator
More Information
Study ID Numbers Virahep-C; U01 DK60329
Date study startedJuly 2002
Record last reviewed June 2002
NLM Identifier NCT00038974
ClinicalTrials.gov processed this record on 2002-08-08
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