Dose-Response Study of Ibalizumab (Monoclonal Antibody) Plus Optimized Background Regimen in Patients With HIV-1
NCT ID: NCT00784147
Last Updated: 2014-05-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
113 participants
INTERVENTIONAL
2008-08-31
2011-04-30
Brief Summary
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Detailed Description
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* Evaluate the dose-response relationship of antiviral activity of the ibalizumab dose regimens at Week 24 in order to determine the optimal dose and regimen. The primary evaluation of effectiveness will be based on the proportion of patients achieving undetectable viral loads at Week 24.
* Evaluate the safety and tolerability of two dose regimens of ibalizumab for dose selection
The secondary objectives of this study are to:
* Evaluate changes from Baseline in viral load, CD4+ cell counts, and time to loss of virologic response (TLOVR)
* Characterize HIV-1 sensitivity/susceptibility changes associated with ibalizumab administration in combination with OBR
* Determine the presence and significance of anti-ibalizumab antibodies, if any (immunogenicity of ibalizumab)
* Assess CD4 receptor density and occupancy
* Determine the impact of ibalizumab on quality of life as assessed by patient-reported outcomes on questionnaires
* Evaluate the pharmacokinetic profile of two dose regimens of ibalizumab at steady state
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ibalizumab 800 mg
every 2 weeks, combined with an Optimized Background Regimen
Ibalizumab
Ibalizumab 800 mg IV every 2 weeks
Ibalizumab 2000 mg
every 4 weeks, combined with an Optimized Background Regimen
Ibalizumab
Ibalizumab 2000 mg IV every 4 weeks
Interventions
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Ibalizumab
Ibalizumab 800 mg IV every 2 weeks
Ibalizumab
Ibalizumab 2000 mg IV every 4 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Have documented HIV-1 infection by official, signed, written history (eg, laboratory report), otherwise an HIV-antibody test will be performed
3. 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
4. Are able and willing to comply with all protocol requirements and procedures
5. Are 18 years of age or older
6. Have a life expectancy that is \>6 months.
7. 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
8. 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
9. 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
10. 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 Criteria
2. 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
3. Any significant acute illness within 1 week before the initial administration of study drug
4. 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
5. Any immunomodulating therapy (including interferon), systemic steroids, or systemic chemotherapy within 12 weeks before randomization
6. Any investigational therapy within 30 days before randomization, except for HIV-agents available in expanded-access programs
7. Any prior exposure to ibalizumab (formerly TNX-355 and Hu5A8)
8. Any vaccination within 21 days before randomization
9. Any female patient who either is pregnant, intends to become pregnant, or is currently breast-feeding
10. 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
11. Any previous clinically significant allergy or hypersensitivity to any excipient in the ibalizumab formulation
12. Any radiation therapy during the 28 days before first administration of investigational medication
13. 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
18 Years
70 Years
ALL
No
Sponsors
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TaiMed Biologics Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Stanley T. Lewis, MD
Role: STUDY_DIRECTOR
TaiMed Biologics Inc.
Locations
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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
Nationsmed Clinical Research
Houston, Texas, United States
Dr. Gordon E. Crofoot, MD, PA
Houston, Texas, United States
Research Access Network
Houston, Texas, United States
Clinical Research Puerto Rico
San Juan, , Puerto Rico
HOPE Clinical Research
San Juan, , Puerto Rico
Countries
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Other Identifiers
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TMB-202 Amendment 2
Identifier Type: -
Identifier Source: org_study_id
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