Investigator-Sponsored Protocol - Continued Use of Ibalizumab
Status: | Completed |
---|---|
Conditions: | HIV / AIDS |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 7/14/2018 |
Start Date: | November 2009 |
End Date: | December 15, 2016 |
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.
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.
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.
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
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