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Investigator-Sponsored Protocol - Continued Use of Ibalizumab

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ibalizumab 800mg Q2Weeks
ibalizumab 2000mg Q4Weeks
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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  • Have not withdrawn or been discontinued from TMB202 9Amendment 2) for any reason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

Sites / Locations

  • Kaiser Permanente Southern California

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

ibalizumab 800mg Q2Weeks

ibalizumab 2000mg Q4Weeks

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 22, 2010
Last Updated
July 10, 2018
Sponsor
Kaiser Permanente
Collaborators
TaiMed Biologics Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01056393
Brief Title
Investigator-Sponsored Protocol - Continued Use of Ibalizumab
Official Title
Investigator-Sponsored Protocol - Continued Use of Ibalizumab
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
December 15, 2016 (Actual)
Study Completion Date
December 15, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kaiser Permanente
Collaborators
TaiMed Biologics Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ibalizumab 800mg Q2Weeks
Arm Type
Experimental
Arm Description
Subject will receive 800mg of ibalizumab every 2 weeks administered by intravenous infusion. All patients also will receive optimized background regimen
Arm Title
ibalizumab 2000mg Q4Weeks
Arm Type
Experimental
Arm Description
Subject will receive 2000mg of ibalizumab every 4 weeks administered by intravenous infusion. All patients also will receive optimized background regimen
Intervention Type
Drug
Intervention Name(s)
ibalizumab 800mg Q2Weeks
Other Intervention Name(s)
TNX-355, TMB-355
Intervention Description
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
Intervention Name(s)
ibalizumab 2000mg Q4Weeks
Other Intervention Name(s)
TNX-355, TMB-355
Intervention Description
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.
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Towner, MD
Organizational Affiliation
Kaiser Permanente
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permanente Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Investigator-Sponsored Protocol - Continued Use of Ibalizumab

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