Study of the Safety of Trogarzo™ Administered as an Undiluted "IV Push"
Status:
Completed
Trial end date:
2021-07-05
Target enrollment:
Participant gender:
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.