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:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2025-12-24 @ 10:41 PM
NCT ID:
NCT00001035
Eligibility Criteria:
Inclusion Criteria
Concurrent Medication:
Allowed:
* Treatment or suppression of opportunistic infections with standard drugs.
* Pneumovax, HIB, tetanus, influenza, and hepatitis B vaccines.
* Clinically indicated antibiotics.
* Short courses of steroids (\< 21 days) for acute problems not related to hepatitis C.
* Other regularly prescribed medications such as analgesics, nonsteroidal anti-inflammatory agents, antipyretics, allergy medications, and oral contraceptives.
Patients must have:
* HIV positivity.
* Documented hepatitis C virus.
* CD4 count \<= 200 cells/mm3.
* No severe liver disease (Grade C Childs-Pugh classification) or chronic liver disease not caused by hepatitis C.
* Willingness to be followed for the duration of treatment and follow-up period.
Prior Medication:
Allowed:
* Prior AZT, ddI, and ddC.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
* Hepatitis B (HBsAg positive).
* Autoimmune hepatitis (FANA titer \>= 1:160 and anti-smooth muscle antibody titer \>= 1:160).
* Wilson's disease.
* alpha-1 antitrypsin deficiency.
* Hemochromatosis.
* Malignancy requiring systemic chemotherapy.
Concurrent Medication:
Excluded:
* Nonnucleoside analog therapy for HIV.
* Biologic response modifiers.
* Systemic cytotoxic chemotherapy.
* Chronic systemic steroid use.
Concurrent Treatment:
Excluded:
* Radiation therapy other than local irradiation to the skin.
Prior Medication:
Excluded:
* Prednisone within 12 weeks prior to study entry (if patient has received prior daily doses for 1 month or longer duration).
* Acute therapy for an infection within 2 weeks prior to study entry.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
13 Years
Study:
NCT00001035
Study Brief:
Protocol Section:
NCT00001035