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Reasons for Non-treatment of Hepatitis C in HCV Mono-infected Patients Versus HCV-HIV Co-infected Patients in a University Setting

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00222859
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : July 30, 2013
Information provided by (Responsible Party):
University of Pittsburgh

Brief Summary:
The specific aims of this study are to determine the treatment prescription rates for Hepatitis C virus (HCV) infection in a cohort of HCV mono-infected, and human immunodeficiency virus (HIV)-HCV co-infected patients and to identify the reasons for non-treatment of HCV in these two groups.

Condition or disease
HIV Infections

Detailed Description:
Despite recent advances in treatment modalities, a large proportion of patients with HCV do not receive treatment. The reasons for non-treatment need to be elucidated to properly address these factors. Appropriate evaluation and treatment of HCV is important in providing the optimal care to these persons. It is also important to document and characterize treatment patterns and prescription rates for policy, resource allocation and funding purposes. This study will determine the rates of treatment for HCV monoinfected and HCV-HIV co-infected patients, and determine the reasons for non-treatment. It will also directly compare the two populations to determine if any differences exist in the reasons for non-treatment. This study has implications for patient care, their health outcomes, policy making, funding and resource allocation.

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Study Type : Observational
Actual Enrollment : 300 participants
Time Perspective: Prospective
Official Title: Reasons for Nontreatment of Hepatitis C in HCV Mono-infected Patients Versus HCV-HIV Co-infected Patients in a University Setting
Study Start Date : March 2005
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. dead or alive at end of project [ Time Frame: December 2011 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with HCV diagnosis

Inclusion Criteria:

  • Patients will be recruited from the Pittsburgh AIDS Center for Treatment (PACT) Clinic and Pitt Treatment and Evaluation Unit (PTEU) and the Center for Liver Diseases (CLD) at the University of Pittsburgh. There are approximately 800 patients in the University of Pittsburgh's PACT/PTEU clinic. Consecutive patients with HCV-HIV co-infection who present to the clinic upon initiation of data gathering would be eligible for participation in this study. An estimated 500-800 patients are seen at the CLD clinic per year, and consecutive patients enrolled in the CLD HCV registry would be considered eligible for this study. To maintain uniformity and consistency of data, only patients seen by one of the study investigators would be enrolled. Recruitment would continue till the study has enrolled 100 HCV-HIV coinfected and 200 HCV mono-infected subjects.

Exclusion Criteria:

  • There are no exclusion criteria, except if the patient refuses to participate in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00222859

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United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
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Principal Investigator: Adeel Butt, MD University of Pittsburgh Medical Center
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Responsible Party: University of Pittsburgh Identifier: NCT00222859    
Other Study ID Numbers: IRB # 0503113
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: July 30, 2013
Last Verified: July 2013
Keywords provided by University of Pittsburgh:
Additional relevant MeSH terms:
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Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections