Investigator-Sponsored Protocol - Continued Use of Ibalizumab

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
TaiMed Biologics Inc.
Information provided by (Responsible Party):
William J. Towner, Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT01056393
First received: January 22, 2010
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
HIV Infections
Drug: ibalizumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Investigator-Sponsored Protocol - Continued Use of Ibalizumab

Resource links provided by NLM:


Further study details as provided by Kaiser Permanente:

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. [ Time Frame: Every two months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 4
Study Start Date: November 2009
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
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 q2weeks, or 2000mg q4weeks.
Other Names:
  • TNX-355
  • TMB-355
Experimental: 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
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 q2weeks, or 2000mg q4weeks.
Other Names:
  • TNX-355
  • TMB-355

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01056393

Locations
United States, California
Kaiser Permanente Southern California
Los Angeles, California, United States, 90027
Sponsors and Collaborators
Kaiser Permanente
TaiMed Biologics Inc.
Investigators
Principal Investigator: William Towner, MD Kaiser Permanente
  More Information

No publications provided

Responsible Party: William J. Towner, Partner Physician, Kaiser Permanente
ClinicalTrials.gov Identifier: NCT01056393     History of Changes
Other Study ID Numbers: 5460
Study First Received: January 22, 2010
Last Updated: April 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Kaiser Permanente:
HIV

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on October 02, 2014