Dose-Response Study of Ibalizumab (Monoclonal Antibody) Plus Optimized Background Regimen in Patients With HIV-1

Completed · Phase 2

Conditions studied: HIV

In brief

The investigational product, ibalizumab, is a humanized IgG4 monoclonal antibody administered via intravenous infusion at 800 mg every 2 weeks or at 2000 mg every 4 weeks. In addition to study drug, all patients will receive an optimized background regimen (OBR), which is a standard-of-care regimen selected by the investigator prior to randomization that is comprised of 2-4 antiretroviral agents. These agents must have been approved by the local regulatory agency or be available through expanded-access programs for treatment of human immunodeficiency virus (HIV).

Key facts

Study ID

NCT00784147

Run by

TaiMed Biologics Inc.

People needed

113

Starts

2008-08-01

Expected to finish

2011-04-01

Last updated by the study team

2014-05-05

Who can join

Age: 18 and older, up to 70. 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 (eg, 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
• Are 18 years of age or older
• Have a life expectancy that is >6 months.
• Have a viral load >1,000 copies/mL and documented decreased susceptibility to at least one NRTI, one NNRTI, and one PI, as measured by resistance testing
• Are receiving a stable highly active antiretroviral regimen for at least 8 weeks before screening and are willing to continue that regimen until the baseline visit, OR (in the past 8 weeks) have failed and are off therapy and are willing to stay off therapy until the baseline visit
• Have viral sensitivity/susceptibility to at least one agent (OSS criteria) 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 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 Center for Disease Control (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 (ie, 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 randomization
• Any investigational therapy within 30 days before randomization, except for HIV-agents available in expanded-access programs
• Any prior exposure to ibalizumab (formerly TNX-355 and Hu5A8)
• Any vaccination within 21 days before randomization
• Any female patient who either is pregnant, intends to become pregnant, or is currently breast-feeding
• 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 toxicity 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

• AIDS Health Care Foundation - Research — Beverly Hills, California, United States
• Living Hope Clinical Foundation — Long Beach, California, United States
• Kaiser Permanente Medical Center — Los Angeles, California, United States
• Quest Clinical Research — San Francisco, California, United States
• Kaiser Permanente Medical Center Research Unit — San Francisco, California, United States
• Kaiser Permanente of Colorado — Denver, Colorado, United States
• National Jewish Medical & Research Center — Denver, Colorado, United States
• Whitman-Walker Clinic — Washington D.C., District of Columbia, United States
• South Florida Clinical Research — Atlantis, Florida, United States
• University of Miami, Miller School of Medicine — Miami, Florida, United States
• Orlando Immunology Center — Orlando, Florida, United States
• Associates in Infectious Diseases — Port Saint Lucie, Florida, United States
• Treasure Coast Infectious Disease Consultants — Vero Beach, Florida, United States
• Triple O Medical Services, Inc. — West Palm Beach, Florida, United States
• Northstar Medical Center — Chicago, Illinois, United States
• Indiana University School of Medicine - Wishard Memorial Hospital — Indianapolis, Indiana, United States
• St. Michael's Medical Center — Newark, New Jersey, United States
• AIDS Community Research Initiative of America — New York, New York, United States
• The Brody School of Medicine at ECU — Greenville, North Carolina, United States
• The Research & Educational Group — Portland, Oregon, United States
• Central Texas Clinical Research — Austin, Texas, United States
• North Texas Infectious Disease Consultants — Dallas, Texas, United States
• Valley AIDS Council — Harlingen, Texas, United States
• Therapeutic Concepts — Houston, Texas, United States
• University of Texas Health Science Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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