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TBM-301 Ibalizumab vs. Optimized Background Regimen in HIV Patients
The Study sponsor (TaiMed Biologics, Inc) made ibalizumab to treat HIV. Ibalizumab is an antibody. The sponsor made ibalizumab to block the HIV virus from getting in your CD4 cells or T-helper cells. This would help stop the HI from making more copies of itself. This study wants to test how safe ibalizumab is and how well it works. Ibalizumab is meant for people, whose HIV is resistant to many types of HIV drugs when taken with other drugs to treat HIV.
Who may be Eligible
Have documented HIV-1 infection; Have no acquired immunodeficiency syndrome (AIDS)-defining events in the 3 months before screening, other than cutaneous Kaposi's sarcoma or wasting syndrome due to HIV; Are 18 years of age or older; Have a life expectancy that is >6 months; Have a viral load >1000 copies/mL and documented resistance as per the protocol; Have a history of at least 6 months on antiretroviral treatment; If sexually active, are willing to use as effective method of contraception during the study and for 30 days after the last administration of the study drug.