Treatment of Hepatitis C in Hemophilic Patients With HIV - Full Text View

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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)

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency hemophilia Help Me Understand Genetics

MedlinePlus related topics: HIV/AIDS Hepatitis Hepatitis A Hepatitis C

Drug Information available for: Ribavirin Peginterferon Alfa-2a

U.S. FDA Resources

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

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Principal Investigator:

Kenneth E. Sherman, MD, PhD

University of Cincinnati

More Information

Additional 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:

Shire NJ, Horn PS, Rouster SD, Stanford S, Eyster ME, Sherman KE; Multicenter Hemophilia Cohort HCV Study Group. HCV kinetics, quasispecies, and clearance in treated HCV-infected and HCV/HIV-1-coinfected patients with hemophilia. Hepatology. 2006 Nov;44(5):1146-57.

Qin H, Shire NJ, Keenan ED, Rouster SD, Eyster ME, Goedert JJ, Koziel MJ, Sherman KE; Multicenter Hemophilia Cohort Study Group. HCV quasispecies evolution: association with progression to end-stage liver disease in hemophiliacs infected with HCV or HCV/HIV. Blood. 2005 Jan 15;105(2):533-41. Epub 2004 Sep 16.

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

Additional relevant MeSH terms:

Acquired Immunodeficiency Syndrome
HIV Infections
Hemophilia A
Hepatitis
Hepatitis A
Hepatitis C
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
Flaviviridae Infections
Ribavirin
Peginterferon alfa-2a
Interferon-alpha

ClinicalTrials.gov processed this record on February 12, 2012