This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
TaiMed Biologics Inc.
ClinicalTrials.gov Identifier:
NCT02475629
First received: June 11, 2015
Last updated: February 6, 2017
Last verified: February 2017
  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: 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

Resource links provided by NLM:


Further study details as provided by TaiMed Biologics Inc.:

Primary Outcome Measures:
  • Day 14 Viral Load Reduction as a Measure of Efficacy [ Time Frame: at Day 14 ]
    Proportion of patients achieving a >/= 0.5 log10 decrease from Day 7/Baseline Viral Load


Secondary Outcome Measures:
  • Undetectable Viral Load as a Measure of Efficacy [ Time Frame: at 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 [ Time Frame: at Day 14 and Week 25/End of Study ]
    Mean change from Day 7/Baseline in viral load at Day 14 and at Week 25/End of Study

  • End of Study Viral Load Reductions as a Measure of Efficacy [ 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 [ Time Frame: at Week 25/End of Study ]
    Mean change from Day 7/Baseline in CD4+ cell count at Week 25/End of Study

  • Viral Sensitivity/Susceptibility Changes Associated with Virologic Failure after Administration of Ibalizumab as a Measure of Efficacy [ Time Frame: Through Week 25/End of Study ]
    HIV-1 sensitivity/susceptibility changes associated with virologic failure after administration of ibalizumab

  • CD4 Receptor Density as a Measure of Pharmacodynamics [ Time Frame: Through Week 25/End of Study ]
    Density of CD4 receptors on CD4+ T-cells

  • CD4 Receptor Occupancy as a Measure of Pharmacodynamics [ Time Frame: Through Week 25/End of Study ]
    Occupancy of CD4 receptors on CD4+ T-cells by ibalizumab

  • Number of Participants with Physical Examination Abnormalities as a Measure of Safety and Tolerability [ Time Frame: Through Week 25/End of Study ]
    Number of participants with physical examination abnormalities associated with the administration of ibalizumab

  • Number of Participants with Vital Sign Measurement Abnormalities as a Measure of Safety and Tolerability [ Time Frame: Through Week 25/End of Study ]
    Number of participants with abnormal vital sign measurements associated with administration of ibalizumab

  • Number of Participants with 12-Lead Electrocardiogram Abnormalities as a Measure of Safety and Tolerability [ Time Frame: Through Week 25/End of Study ]
    Number of participants with abnormal electrocardiogram measurements associated with administration of ibalizumab

  • Number of Participants with Abnormal Clinical Laboratory Parameters as a Measure of Safety and Tolerability [ Time Frame: Through Week 25/End of Study ]
    Number of participants with abnormal clinical laboratory parameters associated with administration of ibalizumab

  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Through Week 25/End of Study ]
    Number of participants with adverse events associated with administration of ibalizumab

  • Number of Participants with Class C AIDS-Defining Events as a Measure of Safety and Tolerability [ Time Frame: Through Week 25/End of Study ]
    Number of participants with CDC Classification System "Class C" AIDS-defining events associated with administration of ibalizumab

  • Immunogenicity of Ibalizumab as a Measure of Safety and Tolerability [ Time Frame: Through Week 25/End of Study ]
    Measured levels of anti-ibalizumab antibodies in participant blood samples


Other Outcome Measures:
  • Patient-Related Assessment - Quality of Life as a Measure of Tolerability [ Time Frame: Week 25/End of Study ]
    Functional Assessment of HIV Infection (FAHI) questionnaire to assess patients' quality of life prior to study drug administration and again at Week 25/End of Study

  • Ibalizumab Serum Concentrations as a Measure of Pharmacokinetics [ Time Frame: Through Week 25/End of Study ]
    Peak and trough concentrations of ibalizumab measured in serum


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 Names:
  • 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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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

  Show 30 Study Locations
Sponsors and Collaborators
TaiMed Biologics Inc.
  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: February 6, 2017

Additional relevant MeSH terms:
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 21, 2017