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Ibalizumab Plus Optimized Background Regimen in Treatment-Experienced Patients With Multi-Drug Resistant HIV-1

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ClinicalTrials.gov Identifier: NCT02707861
Recruitment Status : Completed
First Posted : March 14, 2016
Results First Posted : March 11, 2021
Last Update Posted : March 11, 2021
Sponsor:
Collaborator:
Westat
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
HIV Drug: ibalizumab Drug: Optimized Background Regimen Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Expanded Access Study of Ibalizumab Plus an Optimized Background Regimen (OBR) in Treatment-Experienced Patients Infected With Multi-Drug Resistant (MDR) HIV-1
Study Start Date : March 2016
Actual Primary Completion Date : November 2018
Actual Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Ibalizumab

Arm Intervention/treatment
Experimental: 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

Drug: 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
Other Name: TNX-355, Hu5A8

Drug: 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).
Other Name: antiretroviral therapy

Experimental: 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

Drug: 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
Other Name: TNX-355, Hu5A8

Drug: 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).
Other Name: antiretroviral therapy




Primary Outcome Measures :
  1. Safety and Tolerability of Ibalizumab + OBR [ Time Frame: Through 48 weeks ]
    Number of participants with Grade 3/4 adverse events possibly, probably, or definitely due to ibalizumab

  2. Discontinuations Due to Adverse Events Related to Ibalizumab [ Time Frame: 48 weeks ]
    number of participants discontinuing ibalizumab treatment due to adverse events probably, possibly, or definitely related to ibalizumab

  3. Effectiveness of Ibalizumab + OBR (Cohort 2 Only) [ Time Frame: 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


Secondary Outcome Measures :
  1. Suppression to <50 Copies With Ibalizumab + OBR (Cohort 2 Only) [ Time Frame: 48 weeks ]
    Number of patients in Cohort 2 with HIV-1 RNA levels <50 copies/mL at week 48

  2. Suppression to <400 Copies by Ibalizumab + OBR (Cohort 2 Only) [ Time Frame: 48 weeks ]
    Number of patients in Cohort 2 with HIV-1 RNA levels <400 copies/mL at week 48

  3. Effectiveness of Ibalizumab + OBR by 1.0 Log10 Decrease in Viral Load From Baseline (Cohort 2 Only) [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

(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

Exclusion Criteria:

(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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02707861


Locations
Show Show 32 study locations
Sponsors and Collaborators
TaiMed Biologics Inc.
Westat
Investigators
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Principal Investigator: Stanley T. Lewis, MD, MPH TaiMed Biologics Inc.
  Study Documents (Full-Text)

Documents provided by TaiMed Biologics Inc.:
Study Protocol  [PDF] December 11, 2017
Statistical Analysis Plan  [PDF] August 17, 2018

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Responsible Party: TaiMed Biologics Inc.
ClinicalTrials.gov Identifier: NCT02707861    
Other Study ID Numbers: TMB-311
First Posted: March 14, 2016    Key Record Dates
Results First Posted: March 11, 2021
Last Update Posted: March 11, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by TaiMed Biologics Inc.:
HIV
Resistant
Salvage
ibalizumab
antibody
AIDS
Additional relevant MeSH terms:
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Ibalizumab
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents