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Treatment of Hepatitis C in Hemophilic Patients With HIV
This study has been completed.
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00055341
  Purpose

Pegylated interferon (PEG-interferon) and ribavirin are accepted treatments for hepatitis C virus (HCV) infection. However, HCV infection progresses differently in patients who are coinfected with HIV and in hemophiliacs. This study will evaluate the effectiveness of PEG-interferon and ribavirin for treating HCV in HIV infected hemophiliacs.


Condition Intervention Phase
HIV Infections
Hepatitis C
Hemophilia
Drug: Peginterferon alfa-2a
Drug: Ribavirin
Phase II

Genetics Home Reference related topics: hemophilia
MedlinePlus related topics: AIDS Hepatitis Hepatitis C
Drug Information available for: Ribavirin Peginterferon Alfa-2a Interferon alfa-n1 Interferon alfa-2a Interferons
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title: A Prospective Multicenter, Phase II, Open Label, Controlled Trial Evaluating the Response of Hepatitis C Virus (HCV) to Pegylated Interferon Alpha-2A and Ribavirin in Hemophilic Patients With and Without Coinfection With the Human Immunodeficiency Virus (HIV)

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 22
Study Start Date: March 2002
Estimated Study Completion Date: June 2005
Detailed Description:

Hemophiliacs with symptomatic disease often receive blood products to correct clotting factor deficiencies. Prior to routine use of heat inactivation and screening of donor blood for specific viral pathogens, hemophiliacs were routinely exposed to, and infected with, viruses such as hepatitis B (HBV), HCV, and HIV. Studies in hemophiliacs suggest several important findings that warrant further investigation, including: 1) hemophiliacs infected with HCV may have more rapid progression to liver failure and death; 2) pooled blood concentrate from multiple donors leads to a high risk of mixed infection; and 3) different clinical outcomes and altered immune responses of HIV coinfected hemophiliacs may enhance understanding of mutant virus selection and the associated clinical outcomes. The purpose of this trial is to determine response rates to PEG-interferon and ribavirin in hemophiliacs with HCV alone and with HCV/HIV coinfection.

Participants in this study will be followed for 48 weeks on treatment and up to 36 months after treatment. Participants in this study will be admitted to the Clinical Research Center for 2 days at the beginning of the study. Participants will have 3 additional study visits in the first week of the study. After that, study visits occur at Weeks 2, 4, 8, 12, 16, 24, 32, 40, and 48. The follow-up visits will be at 4, 12, and 24 weeks following the end of treatment. Study visits include a physical exam and blood tests. Patients who do not respond to treatment will be followed in a prospective cohort study for up to 3 additional years so that evolution of the virus and associated immune responses can be evaluated.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Hemophilia A or B
  • Exposure to blood or blood products prior to 1987
  • Participating in "The Second Multicenter Hemophilia Cohort Study (MHCS-II)"
  • HCV reactive by second/third generation ELISA assay and/or RIBA
  • HCV RNA positive (PCR or bDNA methods)
  • Chronic hepatitis confirmed by liver biopsy within 6 months prior to study entry (Note: cirrhosis is not an exclusion factor)
  • HIV infection for coinfected group; HIV viral load of 10,000 copies/ml or less
  • If on antiretroviral drugs, stable regimen for at least 8 weeks prior to study entry
  • Acceptable methods of contraception

Exclusion Criteria

  • Hemoglobin less than 10 g/dl
  • For HIV coinfected group, CD4 count less than 200 cells/mm3 at time of screening visit
  • Previous interferon or ribavirin therapy
  • Corticosteroids or immunomodulatory drugs within 3 months prior to study entry
  • Hepatitis B (HBsAg reactive)
  • Alpha-1 antitrypsin deficiency
  • Wilson's disease
  • Hemochromatosis
  • Autoimmune disorder
  • Decompensated liver disease evidenced by encephalopathy, ascites, or variceal bleed
  • Prothrombin Time greater than 3 seconds above normal (International Normalized Ratio [INR] greater than 1.3)
  • Platelet count less than 90,000/microL
  • Active thyroid disease (thyroid replacement with normal TSH permitted)
  • Chronic renal insufficiency, defined as creatinine greater than 1.5 mg/dl
  • Life-threatening disease processes that could preclude completion of trial
  • Alcohol abuse that the local investigator feels would interfere with compliance
  • Illicit recreational drug use or methadone use within 6 months of study entry
  • Major depression with hospitalization or suicide attempt is a relative, but not absolute, contraindication to therapy based on timing, circumstances, and current stability as assessed by the investigator
  • Pregnant or breastfeeding
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00055341

Locations
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Sponsors and Collaborators
Investigators
Principal Investigator: Kenneth E. Sherman, MD, PhD University of Cincinnati
  More Information

Click here for more information about peginterferon alfa-2a  This link exits the ClinicalTrials.gov site
Clcik here for more information about ribavirin  This link exits the ClinicalTrials.gov site

Publications of Results:
Study ID Numbers: 1R01AI49508-01, 5R01AI049508-02
Study First Received: February 25, 2003
Last Updated: July 29, 2008
ClinicalTrials.gov Identifier: NCT00055341  
Health Authority: United States: Federal Government

Study placed in the following topic categories:
Interferon-alpha
Liver Diseases
Sexually Transmitted Diseases, Viral
Hematologic Diseases
Blood Coagulation Disorders
Interferons
Ribavirin
Acquired Immunodeficiency Syndrome
Hemophilia A
Hepatitis, Viral, Human
Hemostatic Disorders
Immunologic Deficiency Syndromes
Hepatitis
Virus Diseases
Digestive System Diseases
Hemorrhagic Disorders
Genetic Diseases, Inborn
HIV Infections
Sexually Transmitted Diseases
Peginterferon alfa-2a
Hepatitis C
Interferon Alfa-2a
Retroviridae Infections

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Flaviviridae Infections
Molecular Mechanisms of Pharmacological Action
Coagulation Protein Disorders
Infection
Antiviral Agents
Pharmacologic Actions
Blood Coagulation Disorders, Inherited
Therapeutic Uses
Lentivirus Infections

ClinicalTrials.gov processed this record on January 14, 2009