NCT00055341

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for phase_2 hiv-infections

Timeline
Completed

Started Mar 2002

Typical duration for phase_2 hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2002

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 27, 2003

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
Last Updated

July 30, 2008

Status Verified

December 1, 2006

First QC Date

February 25, 2003

Last Update Submit

July 29, 2008

Conditions

HIV InfectionsHepatitis CHemophilia

Interventions

Peginterferon alfa-2aDRUG
RibavirinDRUG

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • 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

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Related Publications (2)

  • 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. doi: 10.1002/hep.21374.

    PMID: 17058240RESULT

  • 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. doi: 10.1182/blood-2004-04-1452. Epub 2004 Sep 16.

    PMID: 15374882RESULT

MeSH Terms

Conditions

HIV InfectionsHepatitis CHemophilia A

Interventions

peginterferon alfa-2aRibavirin

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesHepatitis, Viral, HumanFlaviviridae InfectionsHepatitisLiver DiseasesDigestive System DiseasesBlood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

RibonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Kenneth E. Sherman, MD, PhD

    University of Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH

Study Record Dates

First Submitted

February 25, 2003

First Posted

February 27, 2003

Study Start

March 1, 2002

Study Completion

June 1, 2005

Last Updated

July 30, 2008

Record last verified: 2006-12

Locations

US(1)