Toxicity Substudy of Evaluation of Subcutaneous Proleukin in a Randomised International Trial (ESPRIT): TOXIL-2 Substudy
Status:
Terminated
Trial end date:
2008-12-01
Target enrollment:
Participant gender:
Summary
This substudy is an open-label, randomised study comparing the uptake of recombinant
interleukin-2 (rIL-2) in HIV-1 infected individuals receiving different combinations of
antiemetics and analgesic agents during rIL-2 dosing in ESPRIT. The design is a factorial one
with 4 arms. All patients will receive regular ibuprofen and paracetamol from days 1-6 of the
rIL-2 dosing cycle; in addition, patients will be randomised to receive one of two antiemetic
combinations, i.e. ondansetron or metoclopramide with or without low dose codeine phosphate
as an additional analgesic agent.