Investigator-Sponsored Protocol - Continued Use of Ibalizumab

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Investigator-Sponsored Protocol - Continued Use of Ibalizumab

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: ibalizumab 800mg Q2Weeks
* Drug: ibalizumab 2000mg Q4Weeks


Participation Criteria
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Eligibility Criteria
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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TMB202 and are no longer eligible to participate in TMB-202 due to TMB-202 protocol-defined virologic failure Have not withdrawn or been discontinued from TMB202 9Amendment 2) for any reason Are able and willing to comply with all protocol requirements and procedures Are 18 years of age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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ibalizumab 800mg Q2Weeks<br>Subject will receive 800mg of ibalizumab every 2 weeks administered by intravenous infusion. All patients also will receive optimized background regimen | Drug: ibalizumab 800mg Q2Weeks<br>* Ibalizumab is a humanized IgG4 monoclonal antibody and is provided as a parenteral formulation at a concentration of 25mg/mL in a 10mL glass vial, 8mLs per vial, as the investigational product. Study drug will be administered via intravenous infusion at doses of 800mg every 2 weeks.<br>* Other names: TMB-355;|
| Experimental: ibalizumab 2000mg Q4Weeks<br>Subject will receive 2000mg of ibalizumab every 4 weeks administered by intravenous infusion. All patients also will receive optimized background regimen | Drug: ibalizumab 2000mg Q4Weeks<br>* Ibalizumab is a humanized IgG4 monoclonal antibody and is provided as a parenteral formulation at a concentration of 25mg/mL in a 10mL glass vial, 8mLs per vial, as the investigational product. Study drug will be administered via intravenous infusion at doses of 2000mg every 4 weeks.<br>* Other names: TMB-355;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | Every two months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV