ESPRIT TOXIL-2 UNSW PSO 6361

This substudy is an open-label, randomised study comparing the uptake of 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. The intervention will occur for 6 days beginning at day 1 of the rIL-2 dosing cycle and finishing one day after the last dose of rIL-2 on day 5. It is protocol mandated that patients must receive a minimum of one dosing cycle of rIL-2 during the 6 months in which they are randomised into this substudy. However, if desired they can receive more than one dosing cycle of rIL-2 during this 6 mth period provided that they are not at the CD4+ T-cell goal for the study, it is medically safe for them to do so and that cycling does not occur more frequently than every 6-11 weeks (as per the ESPRIT protocol).