Bavituximab Repeat-Dose Trial in Patients Co-Infected With Chronic Hepatitis C Virus and Human Immunodeficiency Virus

Exclusion Criteria

• •HCV or HIV antiviral therapy within 4 weeks of Day 0
• •Prior exposure to any chimeric antibody
• •Any other cause of liver disease other than chronic hepatitis C, such as autoimmune or alcoholic liver disease.
• •Decompensated clinical liver disease, including a history of prolonged clotting times, hypoalbuminemia, encephalopathy, treatment for elevated ammonia levels, or ascites
• •Any evidence of clinically significant bleeding defined as gross hematuria, hemoptysis, or gastrointestinal bleeding
• •Known history of bleeding diathesis or coagulopathy (e.g., von Willebrand Disease or Hemophilia)
• •Any history of thromboembolic events \[e.g., deep vein thrombosis (DVT) or pulmonary thromboembolism (PE)\]. A history of including central venous catheter-related thrombosis is acceptable if there is documentation of resolution at least 12 months prior to enrollment.
• •Concurrent therapy with oral or parenteral anticoagulants
• •Concurrent hormone therapy (i.e., estrogen contraceptives, hormone replacement, anti-estrogen)
• •Investigational therapy within 4 weeks of Day 0
• •Major surgery within 4 weeks of Day 0
• •Pregnant or nursing women
• •Uncontrolled intercurrent disease (e.g., diabetes, hypertension, thyroid disease)
• •Any history of angina pectoris, coronary artery disease or cerebrovascular accident, or transient ischemic attack
• •A history of any condition requiring anti-platelet therapy with the exception of general cardiovascular prophylaxis with aspirin
• •A history of any condition requiring treatment (past or current) with coumarin-type agents
• •Cardiac arrhythmia requiring medical therapy
• •Serious non-healing wound (including wound healing by secondary intention, ulcer, or bone fracture)
• •Requirement for chronic daily treatment with NSAIDs, antiplatelet drugs (e.g., phosphodiesterase inhibitors, adenosine diphosphate receptor antagonists), or steroids
• •Cancer, autoimmune disease or any disease or concurrent therapy known to cause significant alteration in immunologic function. Corticosteroids administered as pre-treatment, or to treat an adverse event, are allowed.