Clinical Trials

MainTitle

Ibalizumab Plus Optimized Background Regimen in Patient With Multi-Drug Resistant HIV

This study has been completed
Sponsor
TaiMed Biologics Inc.


Information provided by (Responsible Party)
TaiMed Biologics Inc.
ClinicalTrials.gov Identifier
NCT02475629

First received: June 11, 2015
Last updated: March 10, 2020
Last Verified: February 2020
History of Changes
Purpose

Purpose

This Phase 3, single arm, multicenter study will evaluate the safety and effectiveness of ibalizumab in treatment-experienced patients infected with multi-drug resistant HIV-1.

Condition Intervention Phase
HIV

Biological : ibalizumab
Drug : Optimized Background Regimen (OBR)
Phase 3

Study Type: Interventional
Study Design: Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Single Arm, 24-Week, Multicenter Study of Ibalizumab Plus an Optimized Background Regimen (OBR) in Treatment-Experienced Patients Infected With Multi-Drug Resistant HIV-1

Further study details as provided by TaiMed Biologics Inc.:

Primary Outcome Measures

  • Efficacy: Proportion of Participants Achieving a Viral Load Reduction of at Least 0.5 Log 10: ITT-MEF [ Time Frame: Day 14 ]
    Proportion of participants (%) achieving a viral load reduction of at least 0.5 log from baseline (Day 7)
  • Efficacy: Proportion of Subjects With a Viral Load Decrease of at Least 0.5 Log 10 - Protocol Correct [ Time Frame: Day 14 ]
    Proportion of patients (%) with a viral load decrease of at least 0.5 log 10 from baseline (day 7)
Secondary Outcome Measures:
  • Efficacy: Proportion of Patients With Undetectable Viral Load: ITT-MEF [ Time Frame: Week 25 /end of study ]
    Proportion of patients with undetectable Viral Load (<50 copies/mL, and <400 copies/mL)
  • Efficacy: Proportion of Patients With Undetectable HIV-RNA Levels: Protocol Correct [ Time Frame: Week 25/End of Study ]
    Proportion of patients (%) with HIV-RNA levels < 50 copies/mL and < 400 copies/mL at Week 25/End of Study
  • Mean Change in Viral Load as a Measure of Efficacy - ITT-MEF [ Time Frame: Day 7 and Day 14 ]
    Mean change from Day 7/Baseline in log 10 vial load measured at Day 14
  • Mean Change in Viral Load as a Measure of Efficacy - Protocol Correct [ Time Frame: Day 7 and Day 14 ]
    Mean change from Day 7/Baseline in Log 10 viral load measured at Day 14
  • End of Study Viral Load Reductions as a Measure of Efficacy - Intent to Treat Analysis [ Time Frame: at Week 25/End of Study ]
    Proportion of patients achieving a >/= 0.5 log10 and >/= 1.0 log10 decrease from Day 7/Baseline in viral load at Week 25/End of Study
  • End of Study Viral Load Reductions as a Measure of Efficacy - Protocol Correct Analysis [ Time Frame: at Week 25/End of Study ]
    Proportion of patients achieving a >/= 0.5 log10 and >/= 1.0 log10 decrease from Day 7/Baseline in viral load at Week 25/End of Study
  • Mean Change in CD4+ Cell Count as a Measure of Efficacy and Safety - ITT [ Time Frame: Day 7 and Week 25/End of Study ]
    Mean change from Day 7/Baseline in CD4+ cell count at Week 25/End of Study
  • Mean Change in CD4+ Cell Count as a Measure of Efficacy and Safety - Protocol Correct [ Time Frame: Day 7 and Week 25/End of Study ]
    Mean change from Day 7/Baseline in CD4+ cell count at Week 25/End of Study
  • Safety: Proportion of Participants Experiencing Adverse Events [ Time Frame: Through Week 25/End of Study ]
    Proportion of participants experiencing at least one treatment emergent adverse event to week 25/End of Study
  • Proportion of Participants Experiencing Adverse Event Related to Study Drug as a Measure of Safety and Tolerability [ Time Frame: Through Week 25/End of Study ]
    Proportion of participants experiencing a treatment emergent adverse event determined by the investigator to be related to study drug
  • Proportion of Participants Experiencing Serious Adverse Event as a Measure of Safety and Tolerability [ Time Frame: Through Week 25/End of Study ]
    Proportion of participants experiencing at least one serious treatment emergent adverse event, excluding death
  • Proportion of Participants Discontinuing Study Drug Due to Adverse Event [ Time Frame: Through Week 25/End of Study ]
    Proportion of participants discontinuing study drug due to occurrence of treatment emergent adverse event
  • Proportion of Participants Experiencing Adverse Event Grade 3 and Higher as a Measure of Safety and Tolerability [ Time Frame: Through Week 25/End of Study ]
    Proportion of participants experiencing treatment emergent adverse event Grade 3 and higher
  • Proportion of Participants Experiencing Adverse Event With Death as Outcome as a Measure of Safety and Tolerability [ Time Frame: Through Week 25/End of Study ]
    Proportion of participants experiencing treatment emergent adverse event with death as the outcome, regardless of relationship to study drug
  • Proportion of Participants Experiencing New AIDS-defining Adverse Event According to CDC Criteria as a Measure of Safety and Tolerability [ Time Frame: Through Week 25/End of Study ]
    Proportion of participants experiencing treatment emergent adverse event that is AIDS-defining by the CDC adverse event classification criteria for HIV infection
Other Outcome Measures:
  • Pharmacodynamics: CD4 Receptor Occupancy [ Time Frame: At Week 25/End of Study ]
    % of CD receptors occupied by ibalizumab on CD4+ T-cells

Enrollment: 40
Study Start Date: August 2015
Study Completion Date: December 2016
Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: Open-Label Ibalizumab plus OBR
2000 mg intravenous ibalizumab (loading dose) on Day 7 followed in 14 days (on Day 21) by 800 mg intravenous ibalizumab administered once every two weeks, plus an Optimized Background Regimen (OBR) beginning on Day 14.
Biological: ibalizumab

2000mg intravenous ibalizumab (loading dose), followed 14 days later by 800mg intravenous ibalizumab every 2 weeks

Other Name:
  • TNX-355
  • Hu1A8

Drug: Optimized Background Regimen (OBR)

All participants will be prescribed an Optimized Background Regimen of antiretroviral medications selected on the basis of treatment history and the results of Screening viral resistance and tropism testing. The prescribed regimen must contain at least one agent to which the participant's virus is known to be sensitive.

Detailed Description:

This Phase 3, single arm, multicenter study will evaluate the safety and effectiveness of ibalizumab in treatment-experienced patients infected with multi-drug resistant HIV-1. Patients must have been treated with HAART for at least 6 months and be failing or have recently failed (i.e., in the last 8 weeks) therapy to determine baseline viral load.
Days 0-6 of the study will be a "control period." During Days 0 through 6 patients will be monitored on current failing therapy (or no therapy, if the patient has failed and discontinued treatment within the 8 weeks preceding Screening).
Days 7-13 of the study will be an "essential monotherapy period." During Days 7 through 13 patients will continue on current failing therapy and receive one 2000 mg dose (loading dose) of ibalizumab on Day 7. Day 7 is Baseline for the treatment period (Day 7-Week 25).
Day 14-Week 25 of the study will be the "maintenance period." On Day 14 (primary endpoint), the OBR will be initiated and must include at least one agent to which the patient's virus is susceptible. Beginning at Day 21, 800 mg of ibalizumab will be administered every 2 weeks through Week 23.
End of Study evaluations will be performed at Week 25, and a follow-up visit will be conducted at Week 29.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

Inclusion Criteria:

  • 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
  • Have no acquired immunodeficiency syndrome (AIDS)-defining events in the 3 months before Screening, other than cutaneous Kaposi's sarcoma or wasting syndrome due to HIV
  • Are able and willing to comply with all protocol requirements and procedures
  • Have a life expectancy that is >6 months.
  • 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 resistance testing
  • Have a history of at least 6 months on antiretroviral treatment
  • Are receiving a stable highly active antiretroviral regimen for at least 8 weeks before Screening and are willing to continue that regimen until Day 14, OR (in the past 8 weeks) have failed and are off therapy and are willing to stay off therapy until Day 14
  • Have full viral sensitivity/susceptibility to at least one antiretroviral agent, other than ibalizumab, as determined by the screening resistance tests 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 screening resistance tests 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:
  • Any active AIDS-defining illness per Category C conditions according to the Centers for Disease Control and Prevention (CDC) Classification System for HIV Infection, with the following exceptions: cutaneous Kaposi's sarcoma and wasting syndrome due to HIV
  • 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 initial administration of study drug
  • 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 12 weeks before Enrollment
  • Any prior exposure to ibalizumab (formerly TNX-355 and Hu5A8)
  • Any vaccination within 7 days before Enrollment
  • 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
  • Any Grade 3 or 4 laboratory abnormality according to the Division of AIDS 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: NCT02475629

Locations

United States, California
Long Beach Education and Research Consultants
Long Beach, California, United States, 90813
W King Health Care Group
Los Angeles, California, United States, 90008
Southern California Permanente Medical Group
Los Angeles, California, United States, 90027
Ruane Medical and Clinical Research Institute
Los Angeles, California, United States, 90036
Charles R. Drew Univ. of Med. & Science Clinical and Translational Research Center
Los Angeles, California, United States, 90059
Anthony Mills, MD, Inc.
Los Angeles, California, United States, 90069
AIDS Healthcare Foundation
Los Angeles, California, United States, 90211
Palmtree Clinical Research Inc.
Palm Springs, California, United States, 92262
Quest Clinical Research
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
Circle Care Center, LLC
Norwalk, Connecticut, United States, 06850
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
Midway Immunology and Research Center
Fort Pierce, Florida, United States, 34982
University of Miami
Miami, Florida, United States, 33136
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, Maryland
University of Maryland, Institute of Human Virology
Baltimore, Maryland, United States, 21201
United States, Michigan
Henry Ford Health Systems
Detroit, Michigan, United States, 48202
St. John Hospital and Medical Center
Southfield, Michigan, United States, 48075
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
ACRIA
New York, New York, United States, 10018
United States, North Carolina
Carolinas HealthCare System
Charlotte, North Carolina, United States, 28232
United States, Texas
North Texas Infectious Disease Consultants
Dallas, Texas, United States, 75246
Research Access Network
Houston, Texas, United States, 77098
Puerto Rico
Clinical Research PR, Inc
San Juan, Puerto Rico, 75246
Taiwan
E-Da Hospital
Kaohsiung, Taiwan, 82445
National Taiwan University Hospital
Taipei, Taiwan, 10002

Sponsors and Collaborators

TaiMed Biologics Inc.
More Information

More Information


Responsible Party: TaiMed Biologics Inc.  
ClinicalTrials.gov Identifier: NCT02475629   History of Changes  
Other Study ID Numbers: TMB-301  
Study First Received: June 11, 2015  
Last Updated: March 10, 2020  

Additional relevant MeSH terms:
Ibalizumab

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