Investigator-Sponsored Protocol - Continued Use of Ibalizumab

Ibalizumab is to be administered to HIV-infected patients that have responded (defined as a minimum 0.7 log10 decline in HIV-1 viral load from TMB-202 Baseline) on the TMB-202 protocol. In addition to the investigator-selected Optimized Background Regimen, patient(s) will continue to receive the TMB-202 randomized dose of ibalizumab in open-labeled fashion (800mg IV every two weeks or 2000mg IV every four weeks) as per their original drug assignment for the TMB-202 protocol.

Inclusion criteria

• Capable of understanding and have voluntarily signed the ICF
• Have documented HIV-1 infection
• Have successfully completed Protocol TMB202 (Amendment 2)(Week 16)
• Have had at least a 0.7 log10 decline in HIV-1 RNA from baseline at Week 16 and beyond while in TMB202 and are no longer eligible to participate in TMB-202 due to TMB-202 protocol-defined virologic failure
• Have not withdrawn or been discontinued from TMB202 9Amendment 2) for any reason
• Are able and willing to comply with all protocol requirements and procedures
• Are 18 years of age or older
• If sexually active, are willing to use an effective method of contraception during the study and for 30days after the last administration of the study drug.

Exclusion criteria

• Any active AIDS-defining illness per Category C except for cutaneous Kaposi's sarcoma and wasting due to HIV
• Any significant disease (other than HIV-1 infection) or clinically significant findings, including psychiatric and behavioral problems, medical history and/or physical examination that, in the investigator's opinion, would preclude the patient from participating in this study
• 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
• Any previous clinically significant allergy or hypersensitivity to any excipient in the ibalizumab formulation