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| Name | Class |
|---|---|
| Westat | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | 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 | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ibalizumab | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability of Ibalizumab + OBR | Number of participants with Grade 3/4 adverse events possibly, probably, or definitely due to ibalizumab | 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 | 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 | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 48 weeks |
| Suppression to <400 Copies by Ibalizumab + OBR (Cohort 2 Only) |
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Inclusion Criteria:
(Cohort 1)
(Cohort 2)
Exclusion Criteria:
(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:
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| Name | Affiliation | Role |
|---|---|---|
| Stanley T. Lewis, MD, MPH | TaiMed Biologics Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Long Beach Education and Research Consultants | Long Beach | California | 90813 | United States | ||
| Southern California Permanente Medical Group |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 | 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 ibalizumab: 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 Optimized Background Regimen: 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). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 11, 2017 | Jan 7, 2021 |
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| Optimized Background Regimen | Drug | 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). |
|
|
Number of patients in Cohort 2 with HIV-1 RNA levels <400 copies/mL at week 48
| 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 | 48 weeks |
| Los Angeles |
| California |
| 90027 |
| United States |
| Ruane Clinical Research Institute Inc. | Los Angeles | California | 90036 | United States |
| Charles R. Drew University of Medicine and Science, Clinical and Translational Research Center | Los Angeles | California | 90059 | United States |
| Anthony Mills MD Inc. | Los Angeles | California | 90069 | United States |
| Palmtree Clinical Research, Inc. | Palm Springs | California | 92262 | United States |
| eStudy Site | San Francisco | California | 94115 | United States |
| Kaiser Foundation Research Institute | San Francisco | California | 94118 | United States |
| Yale University | New Haven | Connecticut | 06510 | United States |
| Georgetown University School of Medicine | Washington D.C. | District of Columbia | 20007 | United States |
| Gary Richmond, MD, PA | Fort Lauderdale | Florida | 33316 | United States |
| AIDS Healthcare Foundation - Kinder Medical Group | Miami | Florida | 33133 | United States |
| AIDS Healthcare Foundation - South Beach | Miami | Florida | 33140 | United States |
| Orlando Immunology Center | Orlando | Florida | 32803 | United States |
| Triple O Research Institute | West Palm Beach | Florida | 33401 | United States |
| AIDS Research Consortium of Atlanta | Atlanta | Georgia | 30312 | United States |
| University of Hawaii - John A. Burns School of Medicine | Honolulu | Hawaii | 96813 | United States |
| Howard Brown Health Center | Chicago | Illinois | 60613 | United States |
| National Institute of Allergy & Infectious Diseases | Bethesda | Maryland | 20892 | United States |
| ID Research Institute | Springfield | Massachusetts | 01105 | United States |
| Central West Clinical Research | St Louis | Missouri | 63108 | United States |
| AIDS Healthcare Foundation - Manhattan Midtown HCC | New York | New York | 10001 | United States |
| Chelsea Village Medical | New York | New York | 10011 | United States |
| Jacobi Medical Center | The Bronx | New York | 10461 | United States |
| East Carolina University | Greenville | North Carolina | 27834 | United States |
| Philadelphia FIGHT | Philadelphia | Pennsylvania | 19107 | United States |
| St. Jude's Children's Research Hospital | Memphis | Tennessee | 38105 | United States |
| St. Hope Foundation Community Health Center | Bellaire | Texas | 77401 | United States |
| North Texas Infectious Disease Consultants | Dallas | Texas | 75246 | United States |
| Crofoot Research Center | Houston | Texas | 77098 | United States |
| Research Access Network | Houston | Texas | 77098 | United States |
| Clinical Research PR, Inc. | San Juan | 00909 | Puerto Rico |
| FG001 | Cohort 2 | 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 ibalizumab: 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 Optimized Background Regimen: 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). |
| COMPLETED |
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| NOT COMPLETED |
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Intent to treat analysis
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 | 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 ibalizumab: 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 Optimized Background Regimen: 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). |
| BG001 | Cohort 2 | 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 ibalizumab: 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 Optimized Background Regimen: 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). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Number of Study Participants Enrolled | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Safety and Tolerability of Ibalizumab + OBR | Number of participants with Grade 3/4 adverse events possibly, probably, or definitely due to ibalizumab | intent-to-treat | Posted | Number | participants | Through 48 weeks |
|
|
| |||||||||||||||||||||||||||||
| Primary | 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 | intent-to -treat | Posted | Count of Participants | Participants | 48 weeks |
| |||||||||||||||||||||||||||||||
| Primary | 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 | As treated analysis | Posted | Number | participants | 7 days |
| |||||||||||||||||||||||||||||||
| Secondary | 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 | as-treated-population | Posted | Count of Participants | Participants | 48 weeks |
| |||||||||||||||||||||||||||||||
| Secondary | 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 | as-treated-analysis | Posted | Count of Participants | Participants | 48 weeks |
| |||||||||||||||||||||||||||||||
| Secondary | 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 | as treated analysis | Posted | Count of Participants | Participants | 48 weeks |
|
Adverse event data is reported is reported for all subjects who received at least one dose of ibalizumab. The time period of observation ranges from day 1 to day 869 for study participants depending on the duration of ibalizumab therapy.
The definitions of adverse events and methods of collection do not differ from clinical trials.gov definitions and methods.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1 | 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 ibalizumab: 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 Optimized Background Regimen: 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). | 5 | 41 | 16 | 41 | 39 | 41 |
| EG001 | Cohort 2 | 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 ibalizumab: 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 Optimized Background Regimen: 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). | 2 | 38 | 15 | 38 | 37 | 38 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| sepsis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| cardiovascular disorder | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| |
| DVT | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
| |
| pneumonia | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
| |
| acute renal failure | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
| |
| opportunistic infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| diarrhea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| headache | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| nausea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| rash | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
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This trial included multiple populations- Cohort 1 included subjects who were treated with ibalizumab and OBR on previous trials including TMB-301, TMB-202, and 2 subjects on expanded access. The Cohort 2 subjects were subjects with MDR resistant virus who were treated with OBR plus ibalizumab. No subjects completed the planned duration of study as the vast majority were switched to commercial supply of drug when the drug was approved by USFDA.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manager - Clinical Operations | TaiMed Biologics USA Corp. | 713-478-2927 | bbell@taimedbio.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 17, 2018 | Jan 7, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C481504 | ibalizumab |
| D023241 | Antiretroviral Therapy, Highly Active |
| ID | Term |
|---|---|
| D004359 | Drug Therapy, Combination |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
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| United States |
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| United States |
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