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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
79
Intravenous infusion of humanized monoclonal antibody binding with a region of Domain 2 of CD4 receptor, blocking post-attachment conformational changes necessary for HIV cell entry
An investigator-selected, standard-of-care combination regimen of antiretroviral agents for treating HIV-1 infection, selected based upon patient treatment history and the results of previous viral resistance testing. The combination must contain at least one agent other than ibalizumab to which the patient's virus is sensitive (susceptible).
Long Beach Education and Research Consultants
Long Beach, California, United States
Southern California Permanente Medical Group
Los Angeles, California, United States
Ruane Clinical Research Institute Inc.
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
Safety and Tolerability of Ibalizumab + OBR
Number of participants with Grade 3/4 adverse events possibly, probably, or definitely due to ibalizumab
Time frame: Through 48 weeks
Discontinuations Due to Adverse Events Related to Ibalizumab
number of participants discontinuing ibalizumab treatment due to adverse events probably, possibly, or definitely related to ibalizumab
Time frame: 48 weeks
Effectiveness of Ibalizumab + OBR (Cohort 2 Only)
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
Time frame: 7 days
Suppression to <50 Copies With Ibalizumab + OBR (Cohort 2 Only)
Number of patients in Cohort 2 with HIV-1 RNA levels \<50 copies/mL at week 48
Time frame: 48 weeks
Suppression to <400 Copies by Ibalizumab + OBR (Cohort 2 Only)
Number of patients in Cohort 2 with HIV-1 RNA levels \<400 copies/mL at week 48
Time frame: 48 weeks
Effectiveness of Ibalizumab + OBR by 1.0 Log10 Decrease in Viral Load From Baseline (Cohort 2 Only)
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
Time frame: 48 weeks
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Palmtree Clinical Research, Inc.
Palm Springs, California, United States
eStudy Site
San Francisco, California, United States
Kaiser Foundation Research Institute
San Francisco, California, United States
Yale University
New Haven, Connecticut, United States
Georgetown University School of Medicine
Washington D.C., District of Columbia, United States
...and 22 more locations