Investigator-Sponsored Protocol - Continued Use of Ibalizumab

• Status: Completed
• Trial end date: 2016-12-15
• Target enrollment: 0
• Participant gender: All

Summary

This protocol serves to extend the successful treatment for HIV positive patients beyond the endpoints provided by the Phase 2b TaiMed Biologics-sponsored protocol TMB202 (entitled "A Phase 2b Randomized, Double-Blinded, 48-Week, Multicenter, Dose-Response Study of Ibalizumab Plus an Optimized Background Regimen in Treatment-Experienced Patients Infected with HIV-1 (Amended to 24 Week Study)"), for 24 weeks. Ibalizumab may be administered beyond 24 weeks under this protocol as supply permits and patients continue to demonstrate virologic response.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kaiser Permanente
• Collaborator: TaiMed Biologics Inc.
• Treatments: Antibodies, Monoclonal; Ibalizumab

Criteria

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• Have not withdrawn or been discontinued from TMB202 9Amendment 2) for any reason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