Study of the Safety of Trogarzo™ Administered as an Undiluted "IV Push" or an Intramuscular Injection
- Registration Number
- NCT03913195
- Lead Sponsor
- TaiMed Biologics Inc.
- 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.
- Detailed Description
This goal of this Phase 3 is to evaluate the safety and pharmacokinetics of administering Trogarzo 800 mg once every two weeks as an undiluted IV Push over 30 seconds, and as an intramuscular injection in clinically stable HIV-1 infected patients currently receiving treatment with a stable Trogarzo-containing regimen and in healthy volunteers.
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, which will enroll both clinically stable HIV-infected patients on a stable Trogarzo-containing treatment regimen and healthy volunteers. The HIV-infected participants in 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, HIV-infected participants in the Core Group will receive the prescribed dosage of Trogarzo via undiluted IV Push over 30 seconds through Day 71 of the study.
Healthy Volunteers in the Core Group will receive a single loading dose of 2000mg of Trogarzo, followed by three successive doses of 800mg Trogarzo in accordance with the prescribing information in order to reach steady state before pharmacokinetic data for analysis are collected. Thereafter, Healthy Volunteers in the Core Group will follow the same schedule of drug administration and assessments as the HIV-infected participants in the Core Group.
HIV-infected participants in the Intramuscular Injection 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, HIV-infected Intramuscular Injection Group participants will receive the prescribed dosage of Trogarzo via intramuscular injection beginning at Day 29 and continuing through Day 71.
Healthy Volunteers in the Intramuscular Injection Group will receive a single loading dose of 2000mg of Trogarzo, followed by three successive doses of 800mg Trogarzo in accordance with the prescribing information in order to reach steady state before pharmacokinetic data for analysis are collected. Thereafter, Healthy Volunteers in the Intramuscular Injection Group will follow the same schedule of drug administration and assessments as the HIV-infected participants in the Intramuscular Injection Group.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 46
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Sentinel Group ibalizumab-uiyk 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. Core Group ibalizumab-uiyk 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. 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. Intramuscular Injection Group ibalizumab-uiyk HIV-infected Intramuscular Injection 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 Intramuscular Injection. 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.
- Primary Outcome Measures
Name Time Method Safety of Trogarzo given as IV Push over 30 seconds in Sentinel Group 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 10 weeks Percent of subjects in Core Group who complete 100% of all Trogarzo administrations given as infusion/bolus/push as per protocol
Pharmacokinetics(2) of Trogarzo infusion versus IV Push in Core Group 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
Pharmacokinetics(1) of Trogarzo infusion versus intramuscular injection in the Intramuscular Injection Group Day 1 infusion versus Day 71 intramusuclar injection 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 intramuscular injection
Pharmacokinetics(2) of Trogarzo infusion versus intramuscular injection in the Intramuscular Injection Group Day 1 infusion versus Day 71 intramusuclar injection Ratio of Trough Serum levels of Trogarzo given by 15 minute infusion versus Trough Serum levels of Trogarzo given by intramuscular injection
Pharmacokinetics(2) of Trogarzo infusion versus IV Push in Sentinel Group 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
Safety of Trogarzo given as an intramuscular injection in the Intramuscular Injection Group 10 weeks Percent of subjects in Intramuscular Injection 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 Core Group 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(1) of Trogarzo infusion versus IV Push in Sentinel Group 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
- Secondary Outcome Measures
Name Time Method Percent of subjects in the Sentinel Group who fail to maintain virologic control 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 HIV-infected subjects in the Core Group who fail to maintain virologic control 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
Percent of HIV-infected subjects in the Intramuscular Injection Group who fail to maintain virologic control 84 days Percent of HIV-infected subjects in the Intramuscular Injection Group who experience a sustained increase in log HIV-1 RNA levels of greater than 0.5log from baseline
Trial Locations
- Locations (4)
Anthony Mills MD Inc.
🇺🇸Los Angeles, California, United States
Gary Richmond MD, PA
🇺🇸Fort Lauderdale, Florida, United States
North Texas Infectious Disease Consultants
🇺🇸Dallas, Texas, United States
Orlando Immunology Center
🇺🇸Orlando, Florida, United States