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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00222859
• Other study ID #: IRB # 0503113
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: July 29, 2013
• Start date: March 2005
• Est. completion date: December 2011

Study information

• Verified date: July 2013
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• HIV Infections

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	dead or alive at end of project		December 2011	No