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Peginterferon and Ribavirin on Virologic and Immunologic Parameters in Hepatitis C Mono- and Coinfected Patient (PRIVICOP)

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ClinicalTrials.gov Identifier: NCT00150904
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : February 16, 2009
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
UMC Utrecht

Tracking Information
First Submitted Date September 6, 2005
First Posted Date September 8, 2005
Last Update Posted Date February 16, 2009
Study Start Date August 2005
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Peginterferon and Ribavirin on Virologic and Immunologic Parameters in Hepatitis C Mono- and Coinfected Patient (PRIVICOP)
Official Title Request for Blood Samples to Examine the Effect of Peginterferon and Ribavirin on Virologic and Immunologic Parameters in Patients With Hepatitis C and in Patients Coinfected With Hepatitis C and HIV
Brief Summary Hepatitis C and HIV infect worldwide millions of people leading to a high rate of coinfected patient with eventually liver cirrhosis and endstage liver disease. With the currently best available therapy (peginterferon and ribavirin) only less than 50% of patients with HCV genotype 1 will respond. Unknown is what factors determine this difference in treatment outcome. Probably virologic and immunologic factors play a major role. By investigating blood samples of HCV / HIV coinfected patients and HCV mono-infected patients we would like to examine both virologic and immunologic factors possibly responsible for this difference.
Detailed Description

background: each year the Hepatitis C (HCV) and the human immunodeficiency virus (HIV) infect worldwide millions of people. In the western world coinfection of HIV with HCV mainly exists in intravenous drug users. In coinfected patients progression of liver fibrosis to cirrhosis and endstage liver disease is much faster than in patients with only a mono-infection of hepatitis C. With the current treatment regimes response rates differ between HCV genotypes and between coinfected and mono-infected patients. Reasons for this a yet not well understood.

Virology: In the treatment of HCV genotype 1, after 12 weeks treatment success is evaluated (EVR) and if the HCV RNA-load is insufficiently dropped the treatment is stopped. There are indications that this moment of evaluation can be done earlier. Whole blood analysis can be a more sensitive method to determine an earlier EVR.Furthermore there are a few known HCV mutations playing a role in the chronicity of HCV. Lack of treatment response can be caused by other mutations in the HCV genome. Sequencing of the whole HCV genome has not been done very extensively.

Immunology: Proliferation and interferon production by HCV specific CD8 cells is defective. Not very much is known about the HCV-specific CD8 cells responses during treatment with peginterferon and ribavirin. Evidence is gathering that regulatory T-cells (CD4+CD25+) are involved in the process of inhibiting proliferation. Also it is known that the concentration of HCV-specific CD4 and CD8 cells in the liver is higher than in the peripheral blood. Certain homing molecules are probably involved in this process.

Hypothesis:

virologic: 1) at 4 weeks it is possible to determine an EVR; 2) other than the known ,mutations are responsible for the chronicity and unresponsiveness of the HCV virus; 3) whole blood analysis will be able to predict an EVR with more sensitivity than the current HCV-RNA techniques.

immunologic: 1) the specific relation between HCV specific CD4 and CD8 cells will determine if proliferation and production of interferon during therapy with peginterferon and ribavirin is successful. 2) regulatory T cells are inhibiting proliferation and production in chronic HCV infection and the amount of regulatory T cells will diminish during therapy with peginterferon and ribavirin. 3) wich homing molecules are important in the homing of HCV specific CD8 cells to the liver.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition
  • Hepatitis C
  • HIV Infections
Intervention Procedure: venous blood puncture
Study Groups/Cohorts Not Provided
Publications * Arends JE, Boucher CA, Hoepelman AI. Hepatitis C virus and human immunodeficiency virus coinfection: where do we stand? Neth J Med. 2005 May;63(5):156-63. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 13, 2009)
28
Original Enrollment
 (submitted: September 6, 2005)
80
Actual Study Completion Date January 2009
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

All patients where the treating physicians decides to start treatment with peginterferon and ribavirin for treatment of hepatitis C

  • HCV mono-infection or HCV / HIV coinfection
  • Genotype 1
  • Compliant for outpatient visits
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number NCT00150904
Other Study ID Numbers 04-247E
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor UMC Utrecht
Collaborators Hoffmann-La Roche
Investigators
Study Director: I. M. Hoepelman, MD, PhD UMC Utrecht
PRS Account UMC Utrecht
Verification Date February 2009