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

March 10, 2020 updated by: TaiMed Biologics Inc.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • San Juan, Puerto Rico, 75246
        • Clinical Research PR, Inc
  • Taiwan
      • Kaohsiung, Taiwan, 82445
        • E-DA Hospital
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital
  • United States
    • California
      • Long Beach, California, United States, 90813
        • Long Beach Education and Research Consultants
      • Los Angeles, California, United States, 90027
        • Southern California Permanente Medical Group
      • Los Angeles, California, United States, 90069
        • Anthony Mills, MD, Inc.
      • Los Angeles, California, United States, 90008
        • W King Health Care Group
      • Los Angeles, California, United States, 90036
        • Ruane Medical and Clinical Research Institute
      • Los Angeles, California, United States, 90059
        • Charles R. Drew Univ. of Med. & Science Clinical and Translational Research Center
      • Los Angeles, California, United States, 90211
        • AIDS Healthcare Foundation
      • Palm Springs, California, United States, 92262
        • Palmtree Clinical Research Inc.
      • San Francisco, California, United States, 94115
        • Quest Clinical Research
      • San Francisco, California, United States, 94118
        • Kaiser Foundation Research Institute
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale University
      • Norwalk, Connecticut, United States, 06850
        • Circle CARE Center, LLC
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown University School of Medicine
    • Florida
      • Fort Lauderdale, Florida, United States, 33316
        • Gary Richmond, MD, PA
      • Fort Pierce, Florida, United States, 34982
        • Midway Immunology and Research Center
      • Miami, Florida, United States, 33136
        • University of Miami
      • Orlando, Florida, United States, 32803
        • Orlando Immunology Center
      • West Palm Beach, Florida, United States, 33401
        • Triple O Research Institute
    • Georgia
      • Atlanta, Georgia, United States, 30312
        • AIDS Research Consortium of Atlanta
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland, Institute of Human Virology
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health Systems
      • Southfield, Michigan, United States, 48075
        • St. John Hospital and Medical Center
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center
      • New York, New York, United States, 10018
        • ACRIA
    • North Carolina
      • Charlotte, North Carolina, United States, 28232
        • Carolinas Healthcare System
    • Texas
      • Dallas, Texas, United States, 75246
        • North Texas Infectious Disease Consultants
      • Houston, Texas, United States, 77098
        • Research Access Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Day 14
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)
Day 14

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
Week 25 /end of study
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
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
Day 7 and 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
Day 7 and 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
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
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
Day 7 and 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
Day 7 and 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
Through 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
Through Week 25/End of Study
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
Through Week 25/End of Study
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
Through Week 25/End of Study
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
Through Week 25/End of Study
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
Through Week 25/End of Study
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
Through Week 25/End of Study

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pharmacodynamics: CD4 Receptor Occupancy
Time Frame: At Week 25/End of Study
% of CD receptors occupied by ibalizumab on CD4+ T-cells
At Week 25/End of Study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
TaiMed Biologics Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 11, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 19, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 19, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TMB-301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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