Investigator-Sponsored Protocol - Continued Use of Ibalizumab

NCT ID: NCT01056393

Last Updated: 2018-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2016-12-15

Brief 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.

Detailed 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.

Conditions

HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ibalizumab 800mg Q2Weeks

Subject will receive 800mg of ibalizumab every 2 weeks administered by intravenous infusion. All patients also will receive optimized background regimen

Group Type: EXPERIMENTAL

ibalizumab 800mg Q2Weeks

Intervention Type: DRUG

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.

ibalizumab 2000mg Q4Weeks

Subject will receive 2000mg of ibalizumab every 4 weeks administered by intravenous infusion. All patients also will receive optimized background regimen

Group Type: EXPERIMENTAL

ibalizumab 2000mg Q4Weeks

Intervention Type: DRUG

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.

Interventions

ibalizumab 800mg Q2Weeks

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.

Intervention Type: DRUG

ibalizumab 2000mg Q4Weeks

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.

Intervention Type: DRUG

Other Intervention Names

TNX-355; TMB-355; TNX-355; TMB-355

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TaiMed Biologics Inc.

INDUSTRY

Sponsor Role: collaborator

Kaiser Permanente

OTHER

Sponsor Role: lead

Responsible Party

William J. Towner

Partner Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

William Towner, MD

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente

Locations

Kaiser Permanente Southern California

Los Angeles, California, United States

Countries

United States

Other Identifiers

5460

Identifier Type: -

Identifier Source: org_study_id