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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00703560
Recruitment Status : Completed
First Posted : June 23, 2008
Last Update Posted : January 21, 2013
Information provided by (Responsible Party):
Mamta Jain, University of Texas Southwestern Medical Center

Brief Summary:

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 or disease
Hepatitis C

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).

Study Type : Observational
Estimated Enrollment : 72 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Molecular Basis of Interferon Response in HCV
Study Start Date : September 2005
Actual Primary Completion Date : September 2011
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

HIV and HCV genotype 1 coinfected (any race)
HCV genotype 1 (any race)

Primary Outcome Measures :
  1. Comparison of interferon effectiveness (as measured by epsilon) in HIV/HCV to HCV alone and African American to Caucasians. [ Time Frame: 72 weeks ]

Secondary Outcome Measures :
  1. SVR rate in HIV/HCV vs. HCV and African Americans vs. Caucasians [ Time Frame: 72 weeks ]
  2. Comparison of HCV quasi-species diversity [ Time Frame: 72 weeks ]

Biospecimen Retention:   Samples With DNA
serum, peripheral blood mononuclear cells

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with HCV genotype 1 with or without HIV-infection of any race.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00703560

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Mamta Jain, Assistant Professor, University of Texas Southwestern Medical Center Identifier: NCT00703560     History of Changes
Other Study ID Numbers: 102005-009
K23AI065630 ( U.S. NIH Grant/Contract )
First Posted: June 23, 2008    Key Record Dates
Last Update Posted: January 21, 2013
Last Verified: January 2013

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

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