Investigator-Sponsored Protocol - Continued Use of Ibalizumab
This trial is active, not recruiting.
|Collaborator||TaiMed Biologics Inc.|
|Start date||November 2009|
|End date||May 2017|
|Trial size||4 participants|
|Trial identifier||NCT01056393, 5460|
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.
|Intervention model||parallel assignment|
Laboratory testing that includes routine HIV-1 viral load and CD4+ cell counts will be completed to assess the continued benefit of ibalizumab to the patient's HIV treatment.
time frame: Every two months
Male or female participants at least 18 years old.
- 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- Have not withdrawn or been discontinued from TMB202 9Amendment 2) for any reason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.
- 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
|Official title||Investigator-Sponsored Protocol - Continued Use of Ibalizumab|
|Principal investigator||William Towner, MD|
|Description||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.|
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