Last updated on June 2019

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


Brief description of study

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 Study 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.

Clinical Study Identifier: NCT03913195

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Anthony Mills MD Inc.

Los Angeles, CA United States
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Anthony Mills, MD, Inc.

Los Angeles, CA United States
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Recruitment Status: Open


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