NCT00703560

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2005

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 23, 2008

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

January 21, 2013

Status Verified

January 1, 2013

Enrollment Period

6 years

First QC Date

June 19, 2008

Last Update Submit

January 18, 2013

Conditions

Hepatitis C

Keywords

HCVGenotype 1HIV co-infectionviral kineticsHCV quasi-speciesHepatitis C genotype 1HIV Infections

Outcome Measures

Primary Outcomes (1)

  • Comparison of interferon effectiveness (as measured by epsilon) in HIV/HCV to HCV alone and African American to Caucasians.

    72 weeks

Secondary Outcomes (2)

  • SVR rate in HIV/HCV vs. HCV and African Americans vs. Caucasians

    72 weeks

  • Comparison of HCV quasi-species diversity

    72 weeks

Study Arms (2)

1

HIV and HCV genotype 1 coinfected (any race)

2

HCV genotype 1 (any race)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.
  • HCV RNA \>1000 IU/ml.
  • Documented genotype 1 performed by any CLIA certified lab.
  • Men and women age 18 to 65 years.
  • Ability and willingness of subject or legal guardian/representative to give written informed consent.
  • 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:
  • 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.
  • CD4+ cell count ³ 300 cells/mm3 within the prior 12 weeks at a CLIA certified lab or its equivalent.
  • 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.

You may not qualify if:

  • Unwilling to be admitted for 48 hours for serial blood draws for virology studies.
  • Hepatitis B surface antigen (HBsAg) positivity.
  • Prior IFN -based therapy.
  • Current symptomatic HIV disease (i.e., AIDS-defining illnesses).
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Jain MK, Pasipanodya JG, Alder L, Lee WM, Gumbo T. Pegylated interferon fractal pharmacokinetics: individualized dosing for hepatitis C virus infection. Antimicrob Agents Chemother. 2013 Mar;57(3):1115-20. doi: 10.1128/AAC.02208-12. Epub 2012 Nov 26.

    PMID: 23183434DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

serum, peripheral blood mononuclear cells

MeSH Terms

Conditions

Hepatitis CHIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Mamta K. Jain, MD, MPH

    University of Texas Southwestern Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 19, 2008

First Posted

June 23, 2008

Study Start

September 1, 2005

Primary Completion

September 1, 2011

Study Completion

January 1, 2013

Last Updated

January 21, 2013

Record last verified: 2013-01