Trogarzo® IV Slow Push
Currently, maintenance doses of Trogarzo® are administered by IV infusion over 15 minutes every two weeks. Maintenance doses are prepared by diluting 4 vials of Trogarzo® (800 mg in a volume of about 5.3 mL) into a 250 mL intravenous bag of 0.9% Sodium Chloride (normal saline) and then infused.
We have started a clinical study to test the safety and drug levels in blood when an 800 mg maintenance dose of Trogarzo® is administered as an undiluted IV push over 30 seconds. The drug levels of Trogarzo® using the IV Push will be compared to the drug levels of Trogarzo after an IV infusion using the currently approved method.
In the study, about 20 patients receiving a stable Trogarzo®-containing antiretroviral regimen will be enrolled. The patients will start receiving two administrations of Trogarzo® using the currently approved infusion. Subsequent administrations will be given at 800 mg undiluted via IV Push over 30 seconds.