Ibalizumab Plus Optimized Background Regimen in Treatment-Experienced Patients With Multi-Drug Resistant HIV-1
- Registration Number
- NCT02707861
- Lead Sponsor
- TaiMed Biologics Inc.
- Brief Summary
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.
- Detailed Description
Participants will enroll into one of two study cohorts. Cohort 1 will provide continued administration of IV ibalizumab for patients completing a prior ibalizumab clinical trial (TaiMed-sponsored or Investigator-Sponsored). Patients will continue to receive IV infusions of ibalizumab at the dosage assigned in the previous study - either 800 mg once every two weeks, or 2000 mg once every four weeks.
Cohort 2 will provide IV ibalizumab, 800 mg once every two weeks, for qualifying patients with multi-drug resistant HIV-1 and limited treatment options who have never previously received ibalizumab.
Participants may continue in this study for 48 weeks, or until ibalizumab becomes commercially available, whichever occurs first.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 79
(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
(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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 2 Optimized Background Regimen IV ibalizumab (combined with optimized background regimen): 800 mg once every two weeks for qualifying patients who have never received ibalizumab Administered for 48 weeks, or until ibalizumab becomes commercially available Cohort 1 Optimized Background Regimen IV ibalizumab (combined with optimized background regimen): 800 mg once every two weeks for patients receiving that dosage on prior, successfully completed ibalizumab clinical trial OR 2000 mg once every four weeks for patients receiving that dosage on prior, successfully completed ibalizumab clinical trial Administered for 48 weeks, or until ibalizumab becomes commercially available Cohort 1 ibalizumab IV ibalizumab (combined with optimized background regimen): 800 mg once every two weeks for patients receiving that dosage on prior, successfully completed ibalizumab clinical trial OR 2000 mg once every four weeks for patients receiving that dosage on prior, successfully completed ibalizumab clinical trial Administered for 48 weeks, or until ibalizumab becomes commercially available Cohort 2 ibalizumab IV ibalizumab (combined with optimized background regimen): 800 mg once every two weeks for qualifying patients who have never received ibalizumab Administered for 48 weeks, or until ibalizumab becomes commercially available
- Primary Outcome Measures
Name Time Method Effectiveness of Ibalizumab + OBR (Cohort 2 Only) 7 days Number of patients in Cohort 2 achieving at least a 0.5 log change from Baseline in viral load at Day 7 of the study
Safety and Tolerability of Ibalizumab + OBR Through 48 weeks Number of participants with Grade 3/4 adverse events possibly, probably, or definitely due to ibalizumab
Discontinuations Due to Adverse Events Related to Ibalizumab 48 weeks number of participants discontinuing ibalizumab treatment due to adverse events probably, possibly, or definitely related to ibalizumab
- Secondary Outcome Measures
Name Time Method Suppression to <400 Copies by Ibalizumab + OBR (Cohort 2 Only) 48 weeks Number of patients in Cohort 2 with HIV-1 RNA levels \<400 copies/mL at week 48
Effectiveness of Ibalizumab + OBR by 1.0 Log10 Decrease in Viral Load From Baseline (Cohort 2 Only) 48 weeks Number of patients in Cohort 2 achieving at least a 1.0 log10 decrease in viral load from Baseline measurement at all assessment time points
Suppression to <50 Copies With Ibalizumab + OBR (Cohort 2 Only) 48 weeks Number of patients in Cohort 2 with HIV-1 RNA levels \<50 copies/mL at week 48
Trial Locations
- Locations (32)
Palmtree Clinical Research, Inc.
🇺🇸Palm Springs, California, United States
Southern California Permanente Medical Group
🇺🇸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
Triple O Research Institute
🇺🇸West Palm Beach, Florida, United States
AIDS Research Consortium of Atlanta
🇺🇸Atlanta, Georgia, United States
Philadelphia FIGHT
🇺🇸Philadelphia, Pennsylvania, United States
Yale University
🇺🇸New Haven, Connecticut, United States
Long Beach Education and Research Consultants
🇺🇸Long Beach, California, United States
Ruane Clinical Research Institute Inc.
🇺🇸Los Angeles, California, United States
ID Research Institute
🇺🇸Springfield, Massachusetts, United States
Central West Clinical Research
🇺🇸Saint Louis, Missouri, United States
National Institute of Allergy & Infectious Diseases
🇺🇸Bethesda, Maryland, United States
Howard Brown Health Center
🇺🇸Chicago, Illinois, United States
AIDS Healthcare Foundation - Manhattan Midtown HCC
🇺🇸New York, New York, United States
Chelsea Village Medical
🇺🇸New York, New York, United States
East Carolina University
🇺🇸Greenville, North Carolina, United States
St. Hope Foundation Community Health Center
🇺🇸Bellaire, Texas, United States
North Texas Infectious Disease Consultants
🇺🇸Dallas, Texas, United States
Crofoot Research Center
🇺🇸Houston, Texas, United States
St. Jude's Children's Research Hospital
🇺🇸Memphis, Tennessee, United States
Clinical Research PR, Inc.
🇵🇷San Juan, Puerto Rico
Research Access Network
🇺🇸Houston, Texas, United States
eStudy Site
🇺🇸San Francisco, California, United States
Kaiser Foundation Research Institute
🇺🇸San Francisco, California, United States
AIDS Healthcare Foundation - South Beach
🇺🇸Miami, Florida, United States
Georgetown University School of Medicine
🇺🇸Washington, District of Columbia, United States
Orlando Immunology Center
🇺🇸Orlando, Florida, United States
Gary Richmond, MD, PA
🇺🇸Fort Lauderdale, Florida, United States
AIDS Healthcare Foundation - Kinder Medical Group
🇺🇸Miami, Florida, United States
Jacobi Medical Center
🇺🇸Bronx, New York, United States
University of Hawaii - John A. Burns School of Medicine
🇺🇸Honolulu, Hawaii, United States