Effect of lycosomal formulations of lycopene and resveratrol chaperoned with phosphatidylcholine on progression and outcomes of Hepatitis C.

Exclusion Criteria12

• Clinically significant infection, other than HCV, defined as any acute viral, bacterial, or fungal infection, which requires specific therapy.
• Co-infections with Hepatitis B virus and Human immunodeficiency virus (HIV).
• Received any investigational drug agent(s) within 28-days of entry into study.
• Any known pre-existing medical condition that could interfere with the subject's participation in the protocol, including serious psychiatric disorders, CNS trauma or active seizure disorders requiring medication, poorly controlled diabetes mellitus, significant cardiovascular dysfunction within the past 6 months (e.g., angina, congestive heart failure, recent myocardial infarction, severe hypotension, or significant arrhythmia).
• Subjects with ECG showing clinically significant abnormalities.
• Need for frequent blood transfusions.
• Recent History of bleeding or bleeding disorders requiring the restriction in use of anticoagulants during study treatments.
• Active immunologically mediated disease (e.g., inflammatory bowel disease [Crohn's disease, ulcerative colitis], rheumatoid arthritis, idiopathic thrombocytopenia purpura, systemic lupus erythematosus, autoimmune or inherited hemolytic anemia, scleroderma, severe psoriasis).
• Any medical condition, other than HCV, requiring, or likely to require during the course of the study, chronic systemic administration of steroids or other immune-regulatory medications.
• Substance abuse, such as alcohol (~80 gm/day), IV drugs, and inhaled drugs (If the subject has a history of substance abuse, to be considered for inclusion into the protocol, the subject must have abstained from using the abused substance for at least 2 months.
• Any cancer requiring systemic chemotherapy.
• Any other condition that, in the opinion of the principal investigators or treating physicians, would make the subject unsuitable for enrollment, or could interfere with the subject participating in and completing the expanded access protocol.