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Investigator-Sponsored Protocol - Continued Use of Ibalizumab

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01056393
Recruitment Status : Completed
First Posted : January 26, 2010
Last Update Posted : July 12, 2018
Sponsor:
Collaborator:
TaiMed Biologics Inc.
Information provided by (Responsible Party):
William J. Towner, Kaiser Permanente

Study Description
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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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: ibalizumab 800mg Q2Weeks Drug: ibalizumab 2000mg Q4Weeks Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Investigator-Sponsored Protocol - Continued Use of Ibalizumab
Study Start Date : November 2009
Actual Primary Completion Date : December 15, 2016
Actual Study Completion Date : December 15, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Ibalizumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: ibalizumab 800mg Q2Weeks
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
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.
Other Names:
  • TNX-355
  • TMB-355
Experimental: ibalizumab 2000mg Q4Weeks
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
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.
Other Names:
  • TNX-355
  • TMB-355


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01056393


Locations
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United States, California
Kaiser Permanente Southern California
Los Angeles, California, United States, 90027
Sponsors and Collaborators
Kaiser Permanente
TaiMed Biologics Inc.
Investigators
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Principal Investigator: William Towner, MD Kaiser Permanente
More Information
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Responsible Party: William J. Towner, Partner Physician, Kaiser Permanente
ClinicalTrials.gov Identifier: NCT01056393    
Other Study ID Numbers: 5460
First Posted: January 26, 2010    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: July 2018
Keywords provided by William J. Towner, Kaiser Permanente:
HIV
Additional relevant MeSH terms:
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HIV Infections
Blood-Borne Infections
Communicable Diseases
Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Genital Diseases
 Urogenital Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Ibalizumab
Antibodies, Monoclonal
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs