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Ibalizumab Plus Optimized Background Regimen in Treatment-Experienced Patients With Multi-Drug Resistant HIV-1

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2016 by TaiMed Biologics Inc.
Sponsor:
Collaborator:
Westat
Information provided by (Responsible Party):
TaiMed Biologics Inc.
ClinicalTrials.gov Identifier:
NCT02707861
First received: March 8, 2016
Last updated: November 10, 2016
Last verified: November 2016
  Purpose
Ibalizumab is a monoclonal antibody that works by blocking HIV entry into the immune system cells (CD4+ or T-cells) the virus typically infects. Ibalizumab is intended for use in combination with other anti-HIV drugs in people with multi-drug resistant HIV and limited treatment options. This study will collect further information on the safety and tolerability of intravenously administered (IV) ibalizumab combined with an optimized background regimen for treating multi-drug resistant HIV-1 infection, and will provide continuing access to ibalizumab for patients completing a prior ibalizumab clinical trial.

Condition Intervention Phase
HIV
Drug: ibalizumab
Drug: Optimized Background Regimen
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Expanded Access Study of Ibalizumab Plus an Optimized Background Regimen (OBR) in Treatment-Experienced Patients Infected With Multi-Drug Resistant (MDR) HIV-1

Resource links provided by NLM:


Further study details as provided by TaiMed Biologics Inc.:

Primary Outcome Measures:
  • Safety and Tolerability of ibalizumab + OBR assessed by the occurrence of Adverse Events and Discontinuations [ Time Frame: Through 48 weeks ] [ Designated as safety issue: Yes ]
    Safety and tolerability of ibalizumab combined with optimized background regimen, as assessed by the occurrence of Adverse Events and Discontinuations

  • Effectiveness of ibalizumab + OBR by Viral Load Log10 Change from Baseline (Cohort 2 only) [ Time Frame: At 7 days ] [ Designated as safety issue: No ]
    Proportion of patients in Cohort 2 achieving at least a 0.5 log10 decrease from Baseline in viral load at Day 7 of the study


Secondary Outcome Measures:
  • HIV Resistance [ Time Frame: Through 48 weeks ] [ Designated as safety issue: No ]
    HIV-1 sensitivity/susceptibility changes associated with virologic failure after administration of ibalizumab, as assessed by genotypic and phenotypic analysis of samples collected upon the occurrence of virologic failure as compared with Baseline samples

  • Effectiveness of ibalizumab + OBR by Viral Suppression to <50 Copies (Cohort 2 only) [ Time Frame: Through 48 weeks ] [ Designated as safety issue: No ]
    Proportion of patients in Cohort 2 with HIV-1 RNA levels <50 copies/mL at protocol-specified time points

  • Effectiveness of ibalizumab + OBR by Viral Suppression to <400 Copies (Cohort 2 only) [ Time Frame: Through 48 weeks ] [ Designated as safety issue: No ]
    Proportion of patients in Cohort 2 with HIV-1 RNA levels <400 copies/mL at protocol-specified time points

  • Effectiveness of ibalizumab + OBR by Mean Change in Viral Load from Baseline (Cohort 2 only) [ Time Frame: Through 48 weeks ] [ Designated as safety issue: No ]
    The mean change in viral load from Baseline measurement at study Day 7, and all other assessment time points for patients in Cohort 2

  • Effectiveness of ibalizumab + OBR by 0.5 Log10 Decrease in Viral Load from Baseline (Cohort 2 only) [ Time Frame: Through 48 weeks ] [ Designated as safety issue: No ]
    The proportion of patients in Cohort 2 achieving at least a 0.5 log10 decrease in viral load from Baseline measurement at all assessment time points

  • Effectiveness of ibalizumab + OBR by 1.0 Log10 Decrease in Viral Load from Baseline (Cohort 2 only) [ Time Frame: Through 48 weeks ] [ Designated as safety issue: No ]
    The proportion of patients in Cohort 2 achieving at least a 1.0 log10 decrease in viral load from Baseline measurement at all assessment time points


Estimated Enrollment: 50
Study Start Date: March 2016
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1

IV ibalizumab (combined with optimized background regimen):

800 mg once every two weeks for patients receiving that dosage on prior, successfully completed ibalizumab clinical trial

OR

2000 mg once every four weeks for patients receiving that dosage on prior, successfully completed ibalizumab clinical trial

Administered for 48 weeks, or until ibalizumab becomes commercially available

Drug: ibalizumab
Intravenous infusion of humanized monoclonal antibody binding with a region of Domain 2 of CD4 receptor, blocking post-attachment conformational changes necessary for HIV cell entry
Other Name: TNX-355, Hu5A8
Drug: Optimized Background Regimen
An investigator-selected, standard-of-care combination regimen of antiretroviral agents for treating HIV-1 infection, selected based upon patient treatment history and the results of previous viral resistance testing. The combination must contain at least one agent other than ibalizumab to which the patient's virus is sensitive (susceptible).
Experimental: Cohort 2

IV ibalizumab (combined with optimized background regimen):

800 mg once every two weeks for qualifying patients who have never received ibalizumab

Administered for 48 weeks, or until ibalizumab becomes commercially available

Drug: ibalizumab
Intravenous infusion of humanized monoclonal antibody binding with a region of Domain 2 of CD4 receptor, blocking post-attachment conformational changes necessary for HIV cell entry
Other Name: TNX-355, Hu5A8
Drug: Optimized Background Regimen
An investigator-selected, standard-of-care combination regimen of antiretroviral agents for treating HIV-1 infection, selected based upon patient treatment history and the results of previous viral resistance testing. The combination must contain at least one agent other than ibalizumab to which the patient's virus is sensitive (susceptible).

Detailed Description:

Participants will enroll into one of two study cohorts. Cohort 1 will provide continued administration of IV ibalizumab for patients completing a prior ibalizumab clinical trial (TaiMed-sponsored or Investigator-Sponsored). Patients will continue to receive IV infusions of ibalizumab at the dosage assigned in the previous study - either 800 mg once every two weeks, or 2000 mg once every four weeks.

Cohort 2 will provide IV ibalizumab, 800 mg once every two weeks, for qualifying patients with multi-drug resistant HIV-1 and limited treatment options who have never previously received ibalizumab.

Participants may continue in this study for 48 weeks, or until ibalizumab becomes commercially available, whichever occurs first.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

(Cohort 1)

  • Currently receiving ibalizumab via other TaiMed-sponsored or investigator-Sponsored protocol
  • Are capable of understanding and have voluntarily signed the informed consent document

(Cohort 2)

  • 18 years of age or older
  • Are capable of understanding and have voluntarily signed the informed consent document
  • Have documented HIV-1 infection by official, signed, written history (e.g., laboratory report), otherwise an HIV-antibody test will be performed
  • Are able and willing to comply with all protocol requirements and procedures
  • Have a viral load >1,000 copies/mL and documented resistance to at least one antiretroviral medication from each of three classes of antiretroviral medications as measured by previous viral resistance testing (resistance testing is not provided by the study for qualification purposes)
  • Have a history of at least 6 months on antiretroviral treatment
  • Are receiving a failing antiretroviral regimen OR have failed and are off therapy
  • Have viral sensitivity/susceptibility to at least one antiretroviral agent, other than ibalizumab, as determined by previous resistance test performed within 6 months of screening and be willing and able to be treated with at least one agent to which the patient's viral isolate is fully sensitive/susceptible according to the resistance tests used for screening as a component of OBR
  • If sexually active, are willing to use an effective method of contraception during the study and for 30 days after the last administration of the study drug

Exclusion Criteria:

(Cohort 1)

  • There are no Exclusion Criteria for patients meeting the Inclusion Criteria for Cohort 1

(Cohort 2)

  • Eligible for participation in other TaiMed-sponsored clinical trials of ibalizumab
  • Any significant diseases (other than HIV-1 infection) or clinically significant findings, including psychiatric and behavioral problems, determined from screening, medical history and/or physical examination that, in the investigator's opinion, would preclude the patient from participating in this study
  • Any significant acute illness within 1 week before the first administration of investigational medication on this study
  • Any active infection secondary to HIV requiring acute therapy; however, patients that require maintenance therapy (i.e., secondary prophylaxis for opportunistic infections) will be eligible for the study.
  • Any immunomodulating therapy (including interferon), systemic steroids, or systemic chemotherapy within 4 weeks before Day 0
  • Any prior exposure to ibalizumab (formerly TNX-355 and Hu5A8)
  • Any vaccination within 7 days before Day 0
  • Any female patient who either is pregnant, intends to become pregnant, or is currently breastfeeding
  • 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
  • Any radiation therapy during the 28 days before first administration of investigational medication on this study
  • Any clinically significant Grade 3 or 4 laboratory abnormality according to the Division of AIDS (DAIDS) grading scale, except for the following asymptomatic Grade 3 events:

    • triglyceride elevation
    • total cholesterol elevation
  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: NCT02707861

Contacts
Contact: Christine Anderson, PhD 713-353-7911 christineanderson@westat.com
Contact: Tracy Wolbach 240-453-2658 tracywolbach@westat.com

Locations
United States, California
Long Beach Education and Research Consultants Recruiting
Long Beach, California, United States, 90813
Contact: Aaron Yee    562-624-4943    ayee@drschneiderid.com   
Principal Investigator: Jerome DeVente, MD         
Southern California Permanente Medical Group Recruiting
Los Angeles, California, United States, 90027
Contact: Cecia Villarin    323-783-8172 ext 363    Cecia.K.Villarin@kp.org   
Principal Investigator: William Towner, MD         
Ruane Medical and Clinical Research Institute Recruiting
Los Angeles, California, United States, 90036
Contact: Dani Ain    323-954-0400 ext 236    dain@ruanemedical.com   
Principal Investigator: Michael Gottlieb, MD         
Charles R. Drew University of Medicine and Science, Clinical and Translational Research Center Recruiting
Los Angeles, California, United States, 90059
Contact: Laurice Pitts    323-568-3359    orwildapitts@cdrewu.edu   
Principal Investigator: Wilbert Jordan, MD         
Anthony Mills MD Inc. Recruiting
Los Angeles, California, United States, 90069
Contact: Joey Fragoso    310-550-2271    joey.fragoso@millsclinicalresearch.com   
Contact: Ron Knight    310.550.2271    ron@tonymillsmd.com   
Principal Investigator: Tony Mills, MD         
Palmtree Clinical Research, Inc. Recruiting
Palm Springs, California, United States, 92262
Contact: Erik Hernandez    760-778-7799    Ehernandez@palmtreeclinical.com   
Contact: Shayna Phillips    760-778-7799    sphillips@palmtreeclinical.com   
Principal Investigator: Richard Loftus, MD         
Quest Clinical Research Recruiting
San Francisco, California, United States, 94115
Contact: Jane de Leon, PhD, RN    415-353-0800    jdeleon@estudysite.com   
Principal Investigator: Jacob Lalezari, MD         
Kaiser Foundation Research Institute Recruiting
San Francisco, California, United States, 94118
Contact: Brooke Anderson    415-933-3487    Brooke.Anderson@nsmtp.kp.org   
Principal Investigator: Jeffrey Fessel, MD         
United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06510
Contact: Laurie Andrews    203-785-3557    laurie.andrews@yale.edu   
Principal Investigator: Brinda Emu, MD         
United States, District of Columbia
Georgetown University School of Medicine Recruiting
Washington, District of Columbia, United States, 20007
Contact: Maximiliano Menna    202-444-0371    mpm229@georgetown.edu   
Principal Investigator: Princy Kumar, MD         
United States, Florida
Gary Richmond, MD, PA Recruiting
Fort Lauderdale, Florida, United States, 33316
Contact: Vernon F Appleby, RN    954-524-2250 ext 211    vfappleby@earthlink.net   
Principal Investigator: Gary Richmond, MD         
Orlando Immunology Center Recruiting
Orlando, Florida, United States, 32803
Contact: Jeffrey Dinsmore, RN, ACRN    407-409-7125    jdinsmore@oicorlando.com   
Principal Investigator: Edwin DeJesus, MD         
United States, Georgia
AIDS Research Consortium of Atlanta Recruiting
Atlanta, Georgia, United States, 30312
Contact: Bentley Sweeton    404-876-2317 ext 124    BentleyS@arcatlanta.org   
Principal Investigator: Melanie Thompson, MD         
United States, New York
ACRIA - AIDS Community Research Initiative of America Recruiting
New York, New York, United States, 10018
Contact: Yuriy Akulov    212-924-3934    yakulov@acria.org   
Principal Investigator: Jerome Ernst, MD         
United States, Texas
North Texas Infectious Disease Consultants Recruiting
Dallas, Texas, United States, 75246
Contact: Shelby Richardson, LVN    214-276-5646    shelby.richardson@ntidc.org   
Contact: Bryan King, LVN    214-276-5646    bryan.king@ntidc.org   
Principal Investigator: Louis Sloan, MD         
Research Access Network Recruiting
Houston, Texas, United States, 77098
Contact: A.J. Sarabia    713-526-7732    aj.sarabia@theschraderclinic.com   
Principal Investigator: Shannon Schrader, MD         
Puerto Rico
Clinical Research PR, Inc. Recruiting
San Juan, Puerto Rico, 00909
Contact: Yolanda Robles-Cabrera, RN, BSN    787.723.5945    yrobles@clinicalresearchpr.com   
Principal Investigator: Javier Morales, MD         
Sponsors and Collaborators
TaiMed Biologics Inc.
Westat
Investigators
Principal Investigator: Stanley T. Lewis, MD, MPH TaiMed Biologics Inc.
  More Information

Responsible Party: TaiMed Biologics Inc.
ClinicalTrials.gov Identifier: NCT02707861     History of Changes
Other Study ID Numbers: TMB-311 
Study First Received: March 8, 2016
Last Updated: November 10, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by TaiMed Biologics Inc.:
HIV
Resistant
Salvage
ibalizumab
antibody
AIDS

Additional relevant MeSH terms:
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 09, 2016