- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00150904
Peginterferon and Ribavirin on Virologic and Immunologic Parameters in Hepatitis C Mono- and Coinfected Patient (PRIVICOP)
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Utrecht, Netherlands, 3584 CX
- University Medical Center Utrecht
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: I. M. Hoepelman, MD, PhD, UMC Utrecht
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 04-247E
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on HIV Infections
-
University of MinnesotaWithdrawnHIV Infections | HIV/AIDS | Hiv | AIDS | Aids/Hiv Problem | AIDS and InfectionsUnited States
-
University of California, San DiegoUniversity of California, Los Angeles; University of Southern California; California... and other collaboratorsCompleted
-
Gérond'ifRecruiting
-
University of California, DavisCompleted
-
University of California, San DiegoNational Center for Complementary and Integrative Health (NCCIH)CompletedHIV PositiveUnited States
-
University of ChicagoUniversity of Athens; National Development and Research Institutes, Inc.Completed
-
HIV Prevention Trials NetworkNational Institute on Drug Abuse (NIDA); National Institute of Allergy and...CompletedHIV PositiveIndonesia, Ukraine, Vietnam
-
University of ZimbabweCompleted
-
Florida International UniversityCompleted
-
Boston Children's HospitalNational Institute on Minority Health and Health Disparities (NIMHD)Completed
Clinical Trials on venous blood puncture
-
University Children's Hospital, ZurichInstitute of Medical Microbiology, University of Zurich, Zurich, SwitzerlandNot yet recruiting
-
Assiut UniversityCompleted
-
National Taiwan University HospitalCompleted
-
Instituto de fertilidad humana, InSerUniversity of Alabama at Birmingham; Colmédicos S.A.S.; ABAD LaboratorioRecruitingEndocrine System Diseases | Polycystic Ovary Syndrome | HyperandrogenismColombia
-
Prodimed SASUnknownVenous PunctureFrance
-
University Hospital of PatrasCompletedNeovascular Age-related Macular DegenerationGreece
-
Centre Hospitalier Universitaire, AmiensCompletedGeriatric | VenipunctureFrance
-
National Council of Scientific and Technical Research...Merck Sharp & Dohme LLCCompletedInhibition of Platelet Aggregation by Incretins
-
University Hospital, CaenNot yet recruitingAdult Acute Myeloid Leukemia
-
National Taiwan University HospitalUnknownOvarian CancerTaiwan