Clinical Trials

MainTitle

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

This study has been completed
Sponsor
TaiMed Biologics Inc.

Collaborator
Westat

Information provided by (Responsible Party)
TaiMed Biologics Inc.
ClinicalTrials.gov Identifier
NCT02707861

First received: March 8, 2016
Last updated: November 6, 2018
Last Verified: November 2018
History of Changes
Purpose

Purpose

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 Intervention Phase
HIV

Drug : ibalizumab
Drug : Optimized Background Regimen
Phase 3

Study Type: Interventional
Study Design: 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

Further study details as provided by TaiMed Biologics Inc.:

Primary Outcome Measures

  • Safety and Tolerability of ibalizumab + OBR assessed by the occurrence of Adverse Events and Discontinuations [ Time Frame: Through 48 weeks ]
    Safety and tolerability of ibalizumab combined with optimized background regimen, as assessed by the occurrence of Adverse Events and Discontinuations
  • Effectiveness of ibalizumab + OBR by Viral Load Log10 Change from Baseline (Cohort 2 only) [ Time Frame: At 7 days ]
    Proportion of patients in Cohort 2 achieving at least a 0.5 log10 decrease from Baseline in viral load at Day 7 of the study
Secondary Outcome Measures:
  • HIV Resistance [ Time Frame: Through 48 weeks ]
    HIV-1 sensitivity/susceptibility changes associated with virologic failure after administration of ibalizumab, as assessed by genotypic and phenotypic analysis of samples collected upon the occurrence of virologic failure as compared with Baseline samples
  • Effectiveness of ibalizumab + OBR by Viral Suppression to <50 Copies (Cohort 2 only) [ Time Frame: Through 48 weeks ]
    Proportion of patients in Cohort 2 with HIV-1 RNA levels <50 copies/mL at protocol-specified time points
  • Effectiveness of ibalizumab + OBR by Viral Suppression to <400 Copies (Cohort 2 only) [ Time Frame: Through 48 weeks ]
    Proportion of patients in Cohort 2 with HIV-1 RNA levels <400 copies/mL at protocol-specified time points
  • Effectiveness of ibalizumab + OBR by Mean Change in Viral Load from Baseline (Cohort 2 only) [ Time Frame: Through 48 weeks ]
    The mean change in viral load from Baseline measurement at study Day 7, and all other assessment time points for patients in Cohort 2
  • Effectiveness of ibalizumab + OBR by 0.5 Log10 Decrease in Viral Load from Baseline (Cohort 2 only) [ Time Frame: Through 48 weeks ]
    The proportion of patients in Cohort 2 achieving at least a 0.5 log10 decrease in viral load from Baseline measurement at all assessment time points
  • Effectiveness of ibalizumab + OBR by 1.0 Log10 Decrease in Viral Load from Baseline (Cohort 2 only) [ Time Frame: Through 48 weeks ]
    The proportion of patients in Cohort 2 achieving at least a 1.0 log10 decrease in viral load from Baseline measurement at all assessment time points

Enrollment: 79
Study Start Date: March 2016
Study Completion Date: November 2018
Primary Completion Date: November 2018 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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).

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).

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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
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

contacts and locations

Contacts and Locations

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02707861

Locations

United States, California
Long Beach Education and Research Consultants
Long Beach, California, United States, 90813
Southern California Permanente Medical Group
Los Angeles, California, United States, 90027
Ruane Clinical Research Institute Inc.
Los Angeles, California, United States, 90036
Charles R. Drew University of Medicine and Science, Clinical and Translational Research Center
Los Angeles, California, United States, 90059
Anthony Mills MD Inc.
Los Angeles, California, United States, 90069
Palmtree Clinical Research, Inc.
Palm Springs, California, United States, 92262
eStudy Site
San Francisco, California, United States, 94115
Kaiser Foundation Research Institute
San Francisco, California, United States, 94118
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06510
United States, District of Columbia
Georgetown University School of Medicine
Washington, District of Columbia, United States, 20007
United States, Florida
Gary Richmond, MD, PA
Fort Lauderdale, Florida, United States, 33316
AIDS Healthcare Foundation - Kinder Medical Group
Miami, Florida, United States, 33133
AIDS Healthcare Foundation - South Beach
Miami, Florida, United States, 33140
Orlando Immunology Center
Orlando, Florida, United States, 32803
Triple O Research Institute
West Palm Beach, Florida, United States, 33401
United States, Georgia
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States, 30312
United States, Hawaii
University of Hawaii - John A. Burns School of Medicine
Honolulu, Hawaii, United States, 96813
United States, Illinois
Howard Brown Health Center
Chicago, Illinois, United States, 60613
United States, Maryland
National Institute of Allergy & Infectious Diseases
Bethesda, Maryland, United States, 20892
United States, Massachusetts
ID Research Institute
Springfield, Massachusetts, United States, 01105
United States, Missouri
Central West Clinical Research
Saint Louis, Missouri, United States, 63108
United States, New York
Jacobi Medical Center
Bronx, New York, United States, 10461
AIDS Healthcare Foundation - Manhattan Midtown HCC
New York, New York, United States, 10001
Chelsea Village Medical
New York, New York, United States, 10011
United States, North Carolina
East Carolina University
Greenville, North Carolina, United States, 27834
United States, Pennsylvania
Philadelphia FIGHT
Philadelphia, Pennsylvania, United States
United States, Tennessee
St. Jude's Children's Research Hospital
Memphis, Tennessee, United States, 38105
United States, Texas
St. Hope Foundation Community Health Center
Bellaire, Texas, United States, 77401
North Texas Infectious Disease Consultants
Dallas, Texas, United States, 75246
Crofoot Research Center
Houston, Texas, United States, 77098
Research Access Network
Houston, Texas, United States, 77098
Puerto Rico
Clinical Research PR, Inc.
San Juan, Puerto Rico, 00909

Sponsors and Collaborators

TaiMed Biologics Inc.
Westat

Investigators

Principal Investigator: Stanley T. Lewis, MD, MPH TaiMed Biologics Inc.
More Information

More Information


Responsible Party: TaiMed Biologics Inc.  
ClinicalTrials.gov Identifier: NCT02707861   History of Changes  
Other Study ID Numbers: TMB-311  
Study First Received: March 8, 2016  
Last Updated: November 6, 2018  
Individual Participant Data    
Plan to Share IPD: No  

Keywords provided by TaiMed Biologics Inc.:

HIV
Resistant
Salvage
ibalizumab
antibody
AIDS

Additional relevant MeSH terms:
Ibalizumab

ClinicalTrials.gov processed this data on June 02, 2020
This information is provided by ClinicalTrials.gov.