Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-25 @ 2:15 AM
NCT ID:
NCT00703560
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00703560
Study Brief:
Protocol Section:
NCT00703560