Treatment of Hepatitis C in Hemophilic Patients With HIV

July 29, 2008 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

22

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Principal Investigator: Kenneth E. Sherman, MD, PhD, University of Cincinnati

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2002

Study Completion

June 1, 2005

Study Registration Dates

First Submitted

February 25, 2003

First Submitted That Met QC Criteria

February 26, 2003

First Posted (Estimate)

February 27, 2003

Study Record Updates

Last Update Posted (Estimate)

July 30, 2008

Last Update Submitted That Met QC Criteria

July 29, 2008

Last Verified

December 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R01AI049508-01 (U.S. NIH Grant/Contract)
  • 5R01AI049508-02 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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