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

NCT03913195 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: TMB-302
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 4

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" or intramuscular injection. 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. After completion of the IV Push portion of the study, a second group of 20 participants will be enrolled to evaluate the safety and pharmacokinetics of administration of 800mg via intramuscular injection.

Conditions

HIV-1-infection

Keywords

HIV; ibalizumab; Multi-drug Resistant (MDR) HIV

Outcome Measures

Primary Outcomes (5)

• Safety of Trogarzo Given as IV Push Over 30 Seconds

  Number of subjects who complete 100% of all Trogarzo administrations given as infusion/bolus/push as per protocol

  12 weeks

• Pharmacokinetics Bridge for IV Push and IV Infusion (Ctrough)

  Ratio of proportion of subjects with trough concentration (Ctrough) ≥ the threshold of 300 ng/mL given by 15 minute infusion (IVI) versus IV push (IVP) over 30 seconds

  Day 1 infusion versus Day 85 IV Push

• Pharmacokinetics Bridge for IV Push and IV Infusion (AUC)

  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

  Day 1 infusion versus Day 85 IV Push

• Safety of Trogarzo Given as an Intramuscular Injection in the Intramuscular Injection Group

  Number of subjects in Intramuscular Injection Group who complete 100% of all Trogarzo administrations given as infusion/bolus/push as per protocol

  10 weeks

• Pharmacokinetics Bridge Demonstrated for Intramuscular Injection of Trogarzo and IV Infusion

  Ratio of proportion of subjects with trough concentration (Ctrough) ≥ the threshold of 300 ng/mL given by 15 minute infusion (IVI) versus intramuscular (IM) injection

  Day 1 infusion versus Day 71 intramuscular injection

Study Arms (5)

Sentinel Group-HIV +

EXPERIMENTAL

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.

Drug: ibalizumab-uiyk

Core Group- HIV+

EXPERIMENTAL

HIV-infected 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.

Drug: ibalizumab-uiyk

Core Group-HIV uninfected

EXPERIMENTAL

Healthy Volunteer Core Group participants will receive a single 2000mg loading dose followed by three successive doses of 800mg in accordance with the prescribing information in order to reach steady state. Thereafter, Healthy Volunteers 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.

Drug: ibalizumab-uiyk

Intramuscular Injection Group-HIV+

EXPERIMENTAL

HIV+ participants in this group will receive two successive doses of 800mg ibalizumab (Trogarzo) administered in accordance with the prescribing information followed by four (4) successive 800mg doses via intramuscular injection.

Drug: ibalizumab-uiyk

Intramuscular Injection Group-HIV uninfected

EXPERIMENTAL

Healthy Volunteer Intramuscular Injection Group participants will receive a single 2000mg loading dose followed by three successive doses of 800mg in accordance with the prescribing information in order to reach steady state. Thereafter, Healthy Volunteers will receive two successive doses of 800mg ibalizumab (Trogarzo) administered in accordance with the prescribing information followed by four (4) successive 800mg doses via intramuscular injection.

Drug: ibalizumab-uiyk

Interventions

ibalizumab-uiyk DRUG

Ibalizumab-uiyk is an Immunoglobulin G4 (IgG4) monoclonal antibody targeting domain 2 of the extracellular portion of the Cluster of Differentiation 4 (CD4) protein. Ibalizumab-uiyk is FDA approved for the treatment of multi-drug resistant HIV in treatment experienced patients.

Also known as: Trogarzo

Core Group- HIV+; Core Group-HIV uninfected; Intramuscular Injection Group-HIV uninfected; Intramuscular Injection Group-HIV+; Sentinel Group-HIV +

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are capable of understanding and have voluntarily signed the informed consent document
• Currently receiving a stable Trogarzo-containing antiretroviral (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
• 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
• Are 18 years of age or older
• Have a life expectancy that is \>6 months.
• Have a viral load \<1,000 copies/mL at Screening
• CD4+ T-cell count \> 50 cells/mm3 at Screening
• Prothrombin time (PT) and partial thromboplastin time (PTT) \<1.5 times the upper limit of normal (IM Group only)
• Healthy volunteers born male and female as assessed by medical history and physical examination
• Aged \>18 and \<50 years at the time of Screening
• Ability and willingness to provide written informed consent
• Willingness to comply with protocol schedule
• Willingness to undergo HIV-1 testing
• Non-reactive 4th generation point of care HIV-1 test at Screening

You may not qualify if:

• Any active AIDS-defining illness according to the Centers for Disease Control and Prevention (CDC) Revised Surveillance Case Definitions for HIV Infection 2008 (Morbidity and Mortality Weekly Report (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
• 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 subject 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, subjects 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 vaccination within 7 days before Day 1
• Any female subject 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 subject's ability to comply with the study schedule and protocol evaluations
• Any radiation therapy during the 28 days before first administration of study medication
• Any 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
• or Grade 3 or 4 reductions in levels of CD4+ T cells
• History of coagulopathy that would preclude administration of IM injections (IM Group only)
• Skin rashes or tattoos that would prevent ability to assess IM injection for injection-site reactions (IM Group only)

Sponsors & Collaborators

• TaiMed Biologics Inc.: lead
• Westat: collaborator

Study Sites (4)

Anthony Mills MD Inc.

Los Angeles, California, 90069, United States

Location

Gary Richmond MD, PA

Fort Lauderdale, Florida, 33316, United States

Location

Orlando Immunology Center

Orlando, Florida, 32803, United States

Location

North Texas Infectious Disease Consultants

Dallas, Texas, 75246, United States

Location

MeSH Terms

Interventions

ibalizumab

Limitations and Caveats

Limitations of the trial include:: 1\. difficulty in recruitment of HIV-infected individuals who were using ibalizumab as part of a suppressive regimen as issues with continued supply and reimbursement emerged necessitating the recruitment of HIV-uninfected participants in whom the pharmacokinetics of ibalizumab differ from the HIV-infected population.

Results Point of Contact

• Title: Dr. Kuei-Ling Kuo
• Organization: TaiMed Biologics

kkuo@taimedbio.com

+886-2-26580058

Study Officials

• Martin Markowitz, MD

  TaiMed Biologics Inc. - Consultant

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2019
• First Posted: April 12, 2019
• Study Start: May 30, 2019
• Primary Completion: October 17, 2022
• Study Completion: October 31, 2022
• Last Updated: October 20, 2025
• Results First Posted: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)