Dose-Response Study of Ibalizumab (Monoclonal Antibody) Plus Optimized Background Regimen in Patients With HIV-1

Exclusion Criteria

• •1. Any active AIDS-defining illness per Category C conditions according to the Center for Disease Control (CDC) Classification System for HIV Infection, with the following exceptions: cutaneous Kaposi's sarcoma and wasting syndrome due to HIV
• •2. Any significant diseases (other than HIV-1 infection) or clinically significant findings, including psychiatric and behavioral problems, determined from screening, medical history and/or physical examination that, in the investigator's opinion, would preclude the patient from participating in this study
• •3. Any significant acute illness within 1 week before the initial administration of study drug
• •4. Any active infection secondary to HIV requiring acute therapy; however, patients that require maintenance therapy (ie, secondary prophylaxis for opportunistic infections) will be eligible for the study
• •5. Any immunomodulating therapy (including interferon), systemic steroids, or systemic chemotherapy within 12 weeks before randomization
• •6. Any investigational therapy within 30 days before randomization, except for HIV-agents available in expanded-access programs
• •7. Any prior exposure to ibalizumab (formerly TNX-355 and Hu5A8)
• •8. Any vaccination within 21 days before randomization
• •9. Any female patient who either is pregnant, intends to become pregnant, or is currently breast-feeding
• •10. Any current alcohol or illicit drug use that, in the investigator's opinion, will interfere with the patient's ability to comply with the study schedule and protocol evaluations
• •11. Any previous clinically significant allergy or hypersensitivity to any excipient in the ibalizumab formulation
• •12. Any radiation therapy during the 28 days before first administration of investigational medication
• •13. Any grade 3 or 4 toxicity according to the Division of AIDS grading scale, except for the following asymptomatic grade 3 events: triglyceride elevation \& total cholesterol elevation