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

This study has been completed.
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
UMC Utrecht
ClinicalTrials.gov Identifier:
NCT00150904
First received: September 6, 2005
Last updated: February 13, 2009
Last verified: February 2009
  Purpose

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.


Condition Intervention
Hepatitis C
HIV Infections
Procedure: venous blood puncture

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by UMC Utrecht:

Enrollment: 28
Study Start Date: August 2005
Study Completion Date: January 2009
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00150904

Locations
Netherlands
University Medical Center Utrecht
Utrecht, Netherlands, 3584 CX
Sponsors and Collaborators
UMC Utrecht
Hoffmann-La Roche
Investigators
Study Director: I. M. Hoepelman, MD, PhD UMC Utrecht
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00150904     History of Changes
Other Study ID Numbers: 04-247E
Study First Received: September 6, 2005
Last Updated: February 13, 2009
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by UMC Utrecht:
HIV
hepatitis C
virologic
immunologic
HIV / Hepatitis C coinfection

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Hepatitis
Hepatitis A
Hepatitis C
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
Flaviviridae Infections
Ribavirin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 31, 2014