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 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 12:22 AM
NCT ID:
NCT00545558
Eligibility Criteria:
Inclusion Criteria:
* HCV-infected
* HIV-infected
* Liver biopsy consistent with chronic hepatitis within 1 year of study entry.
* ART-naive or no ART for at least 3 months prior to study entry
Exclusion Criteria:
* Hemoglobin less than 9 g/dl.
* Hepatitis B virus infected or antibody to hepatitis B core antigen, alpha-1 antitrypsin deficiency, Wilson's disease, hemochromatosis, autoimmune disorder, or other concurrent liver disease
* Decompensated liver disease evidenced by active or history of encephalopathy, ascites, or variceal bleeding; prothrombin time (PT) greater than 3 seconds above normal or international normalized ratio (INR) greater than 1.3 sec; platelet count less than 90,000 K/ul. Participants with cirrhosis will not be excluded.
* Active thyroid disease. Participants on thyroid replacement therapy with normal thyroid-stimulating hormone are not excluded.
* Chronic kidney insufficiency, defined as creatinine clearance of greater than approximately 50 ml/min
* Life-threatening disease processes other than HIV or HCV that could interfere with participation in the study
* Any condition that, in the opinion of the investigator, may interfere with completion of the study regimen. This includes severe psychiatric disorders, or active alcohol or recreational drug abuse
* Use of systemic corticosteroids or immunomodulatory drugs within 1 month prior to study entry
* Current or prior successful interferon treatment
* Pregnancy or breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00545558
Study Brief:
Protocol Section:
NCT00545558