Status:
COMPLETED
Dose-Response Study of Ibalizumab (Monoclonal Antibody) Plus Optimized Background Regimen in Patients With HIV-1
Lead Sponsor:
TaiMed Biologics Inc.
Conditions:
HIV
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
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, a...
Detailed Description
The primary objectives of this study are to: * Evaluate the dose-response relationship of antiviral activity of the ibalizumab dose regimens at Week 24 in order to determine the optimal dose and regi...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
113 Patients enrolled
Trial Details
Trial ID
NCT00784147
Start Date
August 1 2008
End Date
April 1 2011
Last Update
May 5 2014
Active Locations (30)
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1
AIDS Health Care Foundation - Research
Beverly Hills, California, United States, 90211
2
Living Hope Clinical Foundation
Long Beach, California, United States, 90813
3
Kaiser Permanente Medical Center
Los Angeles, California, United States, 90027
4
Quest Clinical Research
San Francisco, California, United States, 94115