Ibalizumab Plus Optimized Background Regimen in Treatment-Experienced Patients With Multi-Drug Resistant HIV-1
NCT ID: NCT02707861
Last Updated: 2021-03-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
79 participants
INTERVENTIONAL
2016-03-31
2018-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
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
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).
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
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
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).
Interventions
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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
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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
(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
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Westat
OTHER
TaiMed Biologics Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Stanley T. Lewis, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
TaiMed Biologics Inc.
Locations
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Long Beach Education and Research Consultants
Long Beach, California, United States
Southern California Permanente Medical Group
Los Angeles, California, United States
Ruane Clinical Research Institute Inc.
Los Angeles, California, United States
Charles R. Drew University of Medicine and Science, Clinical and Translational Research Center
Los Angeles, California, United States
Anthony Mills MD Inc.
Los Angeles, California, United States
Palmtree Clinical Research, Inc.
Palm Springs, California, United States
eStudy Site
San Francisco, California, United States
Kaiser Foundation Research Institute
San Francisco, California, United States
Yale University
New Haven, Connecticut, United States
Georgetown University School of Medicine
Washington D.C., District of Columbia, United States
Gary Richmond, MD, PA
Fort Lauderdale, Florida, United States
AIDS Healthcare Foundation - Kinder Medical Group
Miami, Florida, United States
AIDS Healthcare Foundation - South Beach
Miami, Florida, United States
Orlando Immunology Center
Orlando, Florida, United States
Triple O Research Institute
West Palm Beach, Florida, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States
University of Hawaii - John A. Burns School of Medicine
Honolulu, Hawaii, United States
Howard Brown Health Center
Chicago, Illinois, United States
National Institute of Allergy & Infectious Diseases
Bethesda, Maryland, United States
ID Research Institute
Springfield, Massachusetts, United States
Central West Clinical Research
St Louis, Missouri, United States
AIDS Healthcare Foundation - Manhattan Midtown HCC
New York, New York, United States
Chelsea Village Medical
New York, New York, United States
Jacobi Medical Center
The Bronx, New York, United States
East Carolina University
Greenville, North Carolina, United States
Philadelphia FIGHT
Philadelphia, Pennsylvania, United States
St. Jude's Children's Research Hospital
Memphis, Tennessee, United States
St. Hope Foundation Community Health Center
Bellaire, Texas, United States
North Texas Infectious Disease Consultants
Dallas, Texas, United States
Crofoot Research Center
Houston, Texas, United States
Research Access Network
Houston, Texas, United States
Clinical Research PR, Inc.
San Juan, , Puerto Rico
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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TMB-311
Identifier Type: -
Identifier Source: org_study_id
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