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Study of the Safety of Trogarzo™ Administered as an Undiluted "IV Push"

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ClinicalTrials.gov Identifier: NCT03913195
Recruitment Status : Recruiting
First Posted : April 12, 2019
Last Update Posted : June 13, 2019
Sponsor:
Collaborator:
Westat
Information provided by (Responsible Party):
TaiMed Biologics Inc.

Tracking Information
First Submitted Date  ICMJE April 9, 2019
First Posted Date  ICMJE April 12, 2019
Last Update Posted Date June 13, 2019
Actual Study Start Date  ICMJE May 30, 2019
Estimated Primary Completion Date May 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 11, 2019)
  • Safety of Trogarzo given as IV Push over 30 seconds in Sentinel Group [ Time Frame: 12 weeks ]
    Percent of subjects in Sentinel Group who complete 100% of all Trogarzo administrations given as infusion/bolus/push as per protocol
  • Safety of Trogarzo given as IV Push over 30 seconds in Core Group [ Time Frame: 10 weeks ]
    Percent of subjects in Core Group who complete 100% of all Trogarzo administrations given as infusion/bolus/push as per protocol
  • Pharmacokinetics(1) of Trogarzo infusion versus IV Push in Sentinel Group [ Time Frame: Day 1 infusion versus Day 85 IV Push ]
    Ratio of Area Under the Curve of Serum levels of Trogarzo given by 15 minute infusion versus Area Under the Curve of Serum levels of Trogarzo given by IV Push over 30 seconds
  • Pharmacokinetics(2) of Trogarzo infusion versus IV Push in Sentinel Group [ Time Frame: Day 1 infusion versus Day 85 IV Push ]
    Ratio of Trough Serum levels of Trogarzo given by 15 minute infusion versus Trough Serum levels of Trogarzo given by IV Push over 30 seconds
  • Pharmacokinetics(1) of Trogarzo infusion versus IV Push in Core Group [ Time Frame: Day 1 infusion versus Day 71 IV Push ]
    Ratio of Area Under the Curve of Serum levels of Trogarzo given by 15 minute infusion versus Area Under the Curve of Serum levels of Trogarzo given by IV Push over 30 seconds
  • Pharmacokinetics(2) of Trogarzo infusion versus IV Push in Core Group [ Time Frame: Day 1 infusion versus Day 71 IV Push ]
    Ratio of Trough Serum levels of Trogarzo given by 15 minute infusion versus Trough Serum levels of Trogarzo given by IV Push over 30 seconds
Original Primary Outcome Measures  ICMJE
 (submitted: April 10, 2019)
  • Safety of Trogarzo given as IV Push over 30 seconds in Sentinal Group [ Time Frame: 12 weeks ]
    Percent of subjects in Sentinel Group who complete 100% of all Trogarzo administrations given as infusion/bolus/push as per protocol
  • Safety of Trogarzo given as IV Push over 30 seconds in Core Group [ Time Frame: 10 weeks ]
    Percent of subjects in Sentinel Group who complete 100% of all Trogarzo Percent of subjects in Sentinel Group who complete 100% of all Trogarzo administrations given as infusion/bolus/push as per protocol
  • Pharmacokinetics(1) of Trogarzo infusion versus IV Push in Sentinel Group [ Time Frame: Day 1 infusion versus Day 85 IV Push ]
    Ratio of Area Under the Curve of Serum levels of Trogarzo given by 15 minute infusion versus Area Under the Curve of Serum levels of Trogarzo given by IV Push over 30 seconds
  • Pharmacokinetics(2) of Trogarzo infusion versus IV Push in Sentinel Group [ Time Frame: Day 1 infusion versus Day 85 IV Push ]
    Ratio of Trough Serum levels of Trogarzo given by 15 minute infusion versus Trough Serum levels of Trogarzo given by IV Push over 30 seconds
  • Pharmacokinetics(1) of Trogarzo infusion versus IV Push in Core Group [ Time Frame: Day 1 infusion versus Day 71 IV Push ]
    Ratio of Area Under the Curve of Serum levels of Trogarzo given by 15 minute infusion versus Area Under the Curve of Serum levels of Trogarzo given by IV Push over 30 seconds
  • Pharmacokinetics(2) of Trogarzo infusion versus IV Push in Core Group [ Time Frame: Day 1 infusion versus Day 71 IV Push ]
    Ratio of Trough Serum levels of Trogarzo given by 15 minute infusion versus Trough Serum levels of Trogarzo given by IV Push over 30 seconds
Change History Complete list of historical versions of study NCT03913195 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2019)
  • Percent of subjects in the Sentinel Group who fail to maintain virologic control [ Time Frame: 99 days ]
    Percent of subjects in the Sentinel group who experience a sustained increase in log HIV-1 RNA levels of greater than 0.5log from baseline
  • Percent of subjects in the Core Group who fail to maintain virologic control [ Time Frame: 84 days ]
    Percent of subjects in the Core group who experience a sustained increase in log HIV-1 RNA levels of greater than 0.5log from baseline
Original Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2019)
  • Percent of subjects in the Sentinel Group who fail to maintain virology control [ Time Frame: 99 days ]
    Percent of subjects in the Sentinel group who experience a sustained increase in log HIV-1 RNA levels of greater than 0.5log from baseline
  • Percent of subjects in the Core Group who fail to maintain virology control [ Time Frame: 84 days ]
    Percent of subjects in the Core group who experience a sustained increase in log HIV-1 RNA levels of greater than 0.5log from baseline
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of the Safety of Trogarzo™ Administered as an Undiluted "IV Push"
Official Title  ICMJE A Phase 3 Study of the Safety of Trogarzo™ Administered as an Undiluted "IV Push" Over a Reduced Interval in Clinically Stable HIV-1 Infected Trogarzo™ Experienced Patients
Brief Summary This study is designed to assess the safety and pharmacokinetic profile of 800 mg Trogarzo once every two weeks administered via "IV Push". An initial "Sentinel Group" of 5 participants will begin receiving 800mg Trogarzo on a gradual schedule of increasing concentration and decreasing administration time until undiluted IV Push over 30 seconds is achieved, while safety and pharmacokinetics are evaluated. If no safety signals are seen, the Core Group of 15 participants will be enrolled. The Core Group will receive 800mg Trogarzo via undiluted IV Push over 30 seconds while safety and pharmacokinetics are monitored.
Detailed Description

This goal of this Phase 3 is to evaluate the safety and pharmacokinetics of administering Trogarz 800 mg once every two weeks as an undiluted IV Push over 30 seconds in clinically stable HIV-1 infected patients currently receiving treatment with a stable Trogarz-containing regimen.

The first five (5) patients enrolled will comprise the Sentinel Group. Patients six (6) through twenty (20) (the Core Group) will not be screened until the Sentinel Group has completed Day 99 (14 weeks) of the study and the DSMB has reviewed the data accumulated and given approval for enrollment of the Core Group to proceed.

The Sentinel Group will receive 2 successive doses of Trogarzo in accordance with the prescribing information. Safety and pharmacokinetic data from these administrations will serve as the comparator for each study participant. Beginning at Day 29 and continuing through Day 85, Sentinel Group participants will begin receiving the prescribed dosage of Trogarzo once every two weeks through Day 85 of the study on a schedule of increasing drug concentration and decreasing administration time at each visit to achieve an undiluted IV Push administration of Trogarzo over 30 seconds.

After review of data from the Sentinel Group by a DSMB, if approved the study will continue with enrollment of the Core Group. The Core Group will receive 2 successive doses of Trogarzo in accordance with the prescribing information. Safety and pharmacokinetic data from these administrations will serve as the comparator for each study participant. Thereafter, Core Group participants will receive the prescribed dosage of Trogarzo via undiluted IV Push over 30 seconds through Day 71 of the study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE HIV-1-infection
Intervention  ICMJE Drug: ibalizumab-uiyk
Ibalizumab-uiyk is an IgG4 monoclonal antibody targeting domain 2 of the extracellular portion of the CD4 protein. Ibalizumab-uiyk is FDA approved for the treatment of multi-drug resistant HIV in treatment experienced patients.
Other Name: Trogarzo
Study Arms  ICMJE
  • Experimental: Sentinel Group
    Five (5) participants will receive two successive doses of 800mg ibalizumab administered in accordance with the prescribing information followed by five (5) successive 800mg doses on a schedule gradually increasing drug concentration and decreasing administration time.
    Intervention: Drug: ibalizumab-uiyk
  • Experimental: Core Group
    Core Group participants will receive two successive doses of 800mg ibalizumab (Trogarzo) administered in accordance with the prescribing information followed by four (4) successive 800mg doses via undiluted IV Push over 30 seconds.
    Intervention: Drug: ibalizumab-uiyk
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 10, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 15, 2020
Estimated Primary Completion Date May 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Are capable of understanding and have voluntarily signed the informed consent document
  2. Currently receiving a stable Trogarzo-containing ARV regimen for a minimum of 3 months, and no change in background ARVs anticipated over the period of study participation; a stable regimen is defined as having no changes in dose or frequency and no interruptions greater than or equal to 2 weeks during the 3 month period
  3. 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
  4. Are able and willing to comply with all protocol requirements and procedures
  5. Are 18 years of age or older
  6. Have a life expectancy that is >6 months.
  7. Have a viral load <1,000 copies/mL at Screening
  8. CD4+ T-cell count > 50 cells/mm3 at Screening

Exclusion Criteria:

  1. Any active AIDS-defining illness according to the Centers for Disease Control and Prevention (CDC) Revised Surveillance Case Definitions for HIV Infection 2008 (MMWR Vol.57/No. RR-10, Appendix A), or history of the same during the 3 months preceding Screening, with the following exceptions: cutaneous Kaposi's sarcoma and wasting syndrome due to HIV
  2. 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
  3. Any significant acute illness within 1 week before the initial administration of study drug
  4. 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.
  5. Any immunomodulating therapy (including interferon), systemic steroids, or systemic chemotherapy within 12 weeks before Enrollment
  6. Any vaccination within 7 days before Day 1
  7. Any female patient who either is pregnant, intends to become pregnant, or is currently breastfeeding
  8. 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
  9. Any radiation therapy during the 28 days before first administration of study medication
  10. 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 any Grade 3 or 4 reduction in CD4+ T cell counts
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Tracy Wolbach 240-453-2658 tracywolbach@westat.com
Contact: Christine Anderson, PhD 713-353-7911 christineanderson@westat.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03913195
Other Study ID Numbers  ICMJE TMB-302
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: IPD will not be shared with other researchers.
Responsible Party TaiMed Biologics Inc.
Study Sponsor  ICMJE TaiMed Biologics Inc.
Collaborators  ICMJE Westat
Investigators  ICMJE
Study Chair: Martin Markowitz, MD TaiMed Biologics Inc. - Consultant
PRS Account TaiMed Biologics Inc.
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP