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

Completed · Phase 3

Conditions studied: HIV

In brief

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.

Key facts

Study ID

NCT02707861

Run by

TaiMed Biologics Inc.

People needed

79

Starts

2016-03-01

Expected to finish

2018-11-01

Last updated by the study team

2021-03-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• (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

You may not qualify if…

• (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

Where it is running

• 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

Full record on ClinicalTrials.gov

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