Ibalizumab Plus Optimized Background Regimen in Patient With Multi-Drug Resistant HIV

Completed · Phase 3

Conditions studied: HIV

In brief

This Phase 3, single arm, multicenter study will evaluate the safety and effectiveness of ibalizumab in treatment-experienced patients infected with multi-drug resistant HIV-1.

Key facts

Study ID

NCT02475629

Run by

TaiMed Biologics Inc.

People needed

40

Starts

2015-08-01

Expected to finish

2016-12-01

Last updated by the study team

2020-03-19

Who can join

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

You may qualify if…

• 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
• Have no acquired immunodeficiency syndrome (AIDS)-defining events in the 3 months before Screening, other than cutaneous Kaposi's sarcoma or wasting syndrome due to HIV
• Are able and willing to comply with all protocol requirements and procedures
• Have a life expectancy that is >6 months.
• 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 resistance testing
• Have a history of at least 6 months on antiretroviral treatment
• Are receiving a stable highly active antiretroviral regimen for at least 8 weeks before Screening and are willing to continue that regimen until Day 14, OR (in the past 8 weeks) have failed and are off therapy and are willing to stay off therapy until Day 14
• Have full viral sensitivity/susceptibility to at least one antiretroviral agent, other than ibalizumab, as determined by the screening resistance tests 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 screening resistance tests 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…

• Any active AIDS-defining illness per Category C conditions according to the Centers for Disease Control and Prevention (CDC) Classification System for HIV Infection, with the following exceptions: cutaneous Kaposi's sarcoma and wasting syndrome due to HIV
• 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 initial administration of study drug
• 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 12 weeks before Enrollment
• Any prior exposure to ibalizumab (formerly TNX-355 and Hu5A8)
• Any vaccination within 7 days before Enrollment
• 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
• Any Grade 3 or 4 laboratory abnormality according to the Division of AIDS 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
• W King Health Care Group — Los Angeles, California, United States
• Southern California Permanente Medical Group — Los Angeles, California, United States
• Ruane Medical and Clinical Research Institute — Los Angeles, California, United States
• Charles R. Drew Univ. of Med. & Science Clinical and Translational Research Center — Los Angeles, California, United States
• Anthony Mills, MD, Inc. — Los Angeles, California, United States
• AIDS Healthcare Foundation — Los Angeles, California, United States
• Palmtree Clinical Research Inc. — Palm Springs, California, United States
• Quest Clinical Research — San Francisco, California, United States
• Kaiser Foundation Research Institute — San Francisco, California, United States
• Yale University — New Haven, Connecticut, United States
• Circle Care Center, LLC — Norwalk, 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
• Midway Immunology and Research Center — Ft. Pierce, Florida, United States
• University of Miami — 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 Maryland, Institute of Human Virology — Baltimore, Maryland, United States
• Henry Ford Health Systems — Detroit, Michigan, United States
• St. John Hospital and Medical Center — Southfield, Michigan, United States
• ACRIA — New York, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Carolinas HealthCare System — Charlotte, North Carolina, United States

Full record on ClinicalTrials.gov

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