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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00055341 |
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 |
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HIV Infections Hepatitis C Hemophilia |
Drug: Peginterferon alfa-2a Drug: Ribavirin |
Phase II |
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) |
Estimated Enrollment: | 22 |
Study Start Date: | March 2002 |
Estimated Study Completion Date: | June 2005 |
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.
Ages Eligible for Study: | 15 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
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 |
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 |
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 |