Clinical Trials

MainTitle

Investigator-Sponsored Protocol - Continued Use of Ibalizumab

This study has been completed
Sponsor
Kaiser Permanente

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: July 10, 2018
Last Verified: July 2018
History of Changes
Purpose

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 800mg Q2Weeks
Drug : ibalizumab 2000mg Q4Weeks
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Investigator-Sponsored Protocol - Continued Use of Ibalizumab

Further study details as provided by William J. Towner, 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 ]

Enrollment: 5
Study Start Date: November 2009
Study Completion Date: December 15, 2016
Primary Completion Date: December 15, 2016 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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 Name:
  • 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 Name:
  • 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

Eligibility

Ages Eligible for Study: 18 Years and older  
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

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

More Information


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: July 10, 2018  

Keywords provided by William J. Towner, Kaiser Permanente:

HIV

Additional relevant MeSH terms:
HIV Infections
Ibalizumab
Antibodies, Monoclonal

ClinicalTrials.gov processed this data on May 24, 2020
This information is provided by ClinicalTrials.gov.