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 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 12:16 AM
NCT ID:
NCT00059358
Eligibility Criteria:
Inclusion Criteria
* HCV-infected
* HIV-1 infection
* CD4 cell count \> 200 cells/mm³ within 30 days prior to study entry
* HIV RNA \< 400 copies/ml within 90 days of study entry
* Use of zidovudine, lamivudine, and any PI and/or NNRTI
* ANC value \>= 1,500 ml³ within 30 days of study entry
* Weight \> 50 kg (110 lbs) for women and \> 60 kg (132 lbs) for men
* Acceptable methods of contraception
* Ability and willingness to complete the Baseline Adherence Questionnaire
* Documentation of adherence confirmed by the Baseline Adherence Questionnaire and certified by the study officials
Exclusion Criteria
* Previous ribavirin therapy
* More than 2 months of interferon therapy
* Current use of any NRTI other than ZDV and 3TC
* Hepatitis B surface antigen positive
* Infectious, autoimmune, tumoral, biliary, or vascular liver disease
* Alcohol consumption of more than 50 g/day
* Current use of intravenous drugs
* Hemoglobin levels \< 10 gm/dl
* Methadone use
* Chemotherapy
* Certain medications
* Acute opportunistic or bacterial infection requiring therapy at the time of enrollment
* Hemoglobinopathy (e.g., thalassemia) or any other cause of tendency to hemolysis
* Psychiatric disorders, severe depression, history of suicide attempts, or suicidal ideation
* Renal disease requiring dialysis
* Significant coronary diseases or two or more risk factors for coronary diseases, such as \> 55 years old, hypertension, and cholesterol \> 250 mg/dl
* Any clinically significant diseases (other than HIV and HCV infection) that, in the opinion of study officials, would compromise the outcome of this study
* Pregnancy
* Participation in blinded clinical trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
60 Years
Study:
NCT00059358
Study Brief:
Protocol Section:
NCT00059358