Hepatitis CVKNCT00703560
Study of Hepatitis C Virus (HCV) Viral Kinetics in HIV/HCV and HCV Patients
An observational study of Hepatitis C, run by University of Texas Southwestern Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- Sep 2005to Jan 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with HCV genotype 1 with or without HIV-infection of any race.
Who may be able to join
- 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.
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- 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.
Who cannot join
- Unwilling to be admitted for 48 hours for serial blood draws for virology studies.
- Hepatitis B surface antigen (HBsAg) positivity.
- Prior IFN -based therapy.
- Additional Exclusion for HIV-infected:
- 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.
About this study
Official title: Molecular Basis of Interferon Response in HCV
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.
Read the 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).
- Conditions
- Hepatitis C
- Keywords
- HCV, Genotype 1, HIV co-infection, viral kinetics, HCV quasi-species, Hepatitis C genotype 1, HIV Infections
- Medical subject headings
- Hepatitis C, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | HIV and HCV genotype 1 coinfected (any race) | |
| 2 | HCV genotype 1 (any race) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of interferon effectiveness (as measured by epsilon) in HIV/HCV to HCV alone and African American to Caucasians.
Measured: 72 weeks
Secondary outcomes (2)
SVR rate in HIV/HCV vs. HCV and African Americans vs. Caucasians
Measured: 72 weeks
Comparison of HCV quasi-species diversity
Measured: 72 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2008 (estimated)
- Study startSep 2005
- Primary completionSep 2011
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mamta Jain, University of Texas Southwestern Medical Center
- Investigators
- Mamta K. Jain, MD, MPH, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00703560
- Sponsor's protocol ID
- 102005-009
- Other IDs
- K23AI065630
- Acronym
- VK
- Status last verified
- Jan 2013
- First submitted
- 19 Jun 2008
- Last updated
- 21 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23183434
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Basis of Interferon Response in HCV
- ClinicalTrials.gov ID
- NCT00703560
- Acronym / sponsor ID
- VK / 102005-009
- Conditions
- Hepatitis C
- Keywords
- HCV, Genotype 1, HIV co-infection, viral kinetics, HCV quasi-species, Hepatitis C genotype 1, HIV Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Sep 2005
- Primary completion
- Sep 2011 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 23 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –HIV and HCV genotype 1 coinfected (any race) |
| 2 | – | –HCV genotype 1 (any race) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with HCV genotype 1 with or without HIV-infection of any race.
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison of interferon effectiveness (as measured by epsilon) in HIV/HCV to HCV alone and African American to Caucasians.
Time frame: 72 weeks
2 secondary outcomes
SVR rate in HIV/HCV vs. HCV and African Americans vs. Caucasians
Time frame: 72 weeks
Comparison of HCV quasi-species diversity
Time frame: 72 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2013.
- Derived from this study: PubMed 23183434Jain 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mamta K. Jain, MD, MPH principal investigator
University of Texas Southwestern Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C, run by University of Texas Southwestern Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of interferon effectiveness (as measured by epsilon) in HIV/HCV to HCV alone and African American to Caucasians. (time frame: 72 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00703560, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2013.