Phase 3
N=43
Study of the Safety of Trogarzo™ Administered as an Undiluted "IV Push" or an Intramuscular Injection
HIV-1-infection
Bottom Line
View on ClinicalTrials.gov: NCT03913195 ↗Enrolled (actual)
43
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcome: Primary: Safety of Trogarzo Given as IV Push Over 30 Seconds — 5; 4; 10 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ibalizumab-uiyk (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- TaiMed Biologics Inc.
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety of Trogarzo Given as IV Push Over 30 Seconds |
5; 4; 10 | — |
| PRIMARY Pharmacokinetics Bridge for IV Push and IV Infusion (Ctrough) |
5; 3; 10; 5; 3; 10 | 1.0 |
| PRIMARY Pharmacokinetics Bridge for IV Push and IV Infusion (AUC) |
1232.86; 1143.51; 2772.35; 1172.95; 1207.62; 2812.55 | 0.5389 |
| PRIMARY Safety of Trogarzo Given as an Intramuscular Injection in the Intramuscular Injection Group |
6; 13 | — |
| PRIMARY Pharmacokinetics Bridge Demonstrated for Intramuscular Injection of Trogarzo and IV Infusion |
5; 14; 4; 12 | 0.34 |
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.
Eligibility Criteria
Inclusion Criteria - HIV-infected participants (all groups):
- 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 50 cells/mm3 at Screening
- Prothrombin time (PT) and partial thromboplastin time (PTT) 18 and 1.25x upper limit of normal (ULN)
- Aspartate aminotransferase (AST) >1.5x ULN
- Alanine aminotransferase (ALT) >1.5x ULN
- Glucose (non-fasting) >160 mg/dL
- Proteinuria: 2+ or greater
- Hematuria: >10 red blood cells (RBCs) per high-power field
- Previous receipt of an experimental MAb for HIV-1treatment or prevention in a research study
- History of severe allergic reactions to drugs, vaccines, or drug infusion
- Participation in another investigational clinical trial within the past 12 weeks or anticipated during the course of the current study
- 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)
- Use of high-dose aspirin, clopidogrel, prasugrel, ticagrelor, dipyridamole any other antiplatelet medication that would interfere with the ability to receive IM injections (IM Group only).
Data sourced from ClinicalTrials.gov (NCT03913195). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.