Study of Hepatitis C Virus (HCV) Viral Kinetics in HIV/HCV and HCV Patients (VK)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mamta Jain, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00703560
First received: June 19, 2008
Last updated: January 18, 2013
Last verified: January 2013
  Purpose

The purpose of this study is to evaluate what happens to hepatitis C virus in response to treatment with pegylated interferon and ribavirin in patients with HCV compared to those with HIV and HCV.

This research is being done to help us identify how the composition of HCV changes with interferon in different populations. We will examine how quickly HCV is cleared from your body and what factors may influence that clearance. This information may help us find better treatments for HCV.


Condition
Hepatitis C

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Molecular Basis of Interferon Response in HCV

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Comparison of interferon effectiveness (as measured by epsilon) in HIV/HCV to HCV alone and African American to Caucasians. [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • SVR rate in HIV/HCV vs. HCV and African Americans vs. Caucasians [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
  • Comparison of HCV quasi-species diversity [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

serum, peripheral blood mononuclear cells


Estimated Enrollment: 72
Study Start Date: September 2005
Study Completion Date: January 2013
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
HIV and HCV genotype 1 coinfected (any race)
2
HCV genotype 1 (any race)

Detailed Description:

All patients who participate in this study will have frequent blood drawn in order to measure how quickly HCV virus declines. Pegylated interferon and ribavirin are not provided by the study, but will be obtained as part of standard of care treatment for hepatitis C. Participants must be willing to spend 48 hours in the hospital for frequent blood draws. They will be compensated for their time.

All patients must be HCV genotype 1. All patients must have a liver biopsy prior to enrollment into study. (This is not provided by the study).

HIV-infected patients must have a CD4 cell count>300. If HIV-infected and on antiretroviral therapy for HIV, they must be on a stable regimen for 12 weeks. The HIV regimen can not include didanosine (Videx).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with HCV genotype 1 with or without HIV-infection of any race.

Criteria

Inclusion Criteria:

  1. HCV infection, as documented by the presence of circulating levels of HCV RNA by any RT-PCR or bDNA assay performed by a laboratory with a CLIA certification or its equivalent within 52 weeks prior to study entry.
  2. HCV RNA >1000 IU/ml.
  3. Documented genotype 1 performed by any CLIA certified lab.
  4. Men and women age 18 to 65 years.
  5. Ability and willingness of subject or legal guardian/representative to give written informed consent.
  6. Female study volunteers of reproductive potential must be willing to use two methods of birth control in order to prevent pregnancy while on IFN/RBV.

For HIV infected patients:

  1. HIV-1 infection, as documented by any licensed ELISA test kit and confirmed by Western blot at any time prior to study entry. HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA is acceptable as an alternative confirmatory test.
  2. CD4+ cell count ³ 300 cells/mm3 within the prior 12 weeks at a CLIA certified lab or its equivalent.
  3. Subject may be HAART naïve, but if on HAART should be on a stable regimen for 12 weeks The HAART regimen cannot include didanosine (Videx). Interaction with ribavirin and didanosine has led to fatal hyperlactatemia in a few patients.

Exclusion Criteria:

  1. Unwilling to be admitted for 48 hours for serial blood draws for virology studies.
  2. Hepatitis B surface antigen (HBsAg) positivity.
  3. Prior IFN -based therapy.

Additional Exclusion for HIV-infected:

  1. Current symptomatic HIV disease (i.e., AIDS-defining illnesses).
  2. HAART regimen that contains Videx (Didanosine). Subject may previously have been on didanosine but if on a new HAART regimen should be on the regimen for 12 weeks.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00703560

Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Mamta K. Jain, MD, MPH UT Southwestern Medical Center
  More Information

No publications provided by University of Texas Southwestern Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mamta Jain, Assistant Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00703560     History of Changes
Other Study ID Numbers: 102005-009, K23 AI065630
Study First Received: June 19, 2008
Last Updated: January 18, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:
HCV
Genotype 1
HIV co-infection
viral kinetics
HCV quasi-species
Hepatitis C genotype 1
HIV Infections

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on April 14, 2014