ESPRIT TOXIL-2 UNSW PSO 6361
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: Toxicity substudy of ESPRIT: TOXIL-2 substudy
University of New South Wales, Sydney, Australia.
168 participants
Sep 1, 2005
Interventional
Conditions
Summary
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.
Eligibility
Inclusion Criteria1
- Patients participating in ESPRIT and randomised to the rIL-2 arm, who: 1. are not at CD4+ T-cell target for the protocol;2. have not received rIL-2 for >2 months;3. have reported both GI upset and constitutional side-effects as one of the reasons for either dose modifying in prior cycles or unwillingness to receive further rIL-2;4. are considered by the Investigator as medically safe to receive further dosing with rIL-2; 5. are willing to receive further dosing with rIL-2 at the dose specified by the Investigator; 6. are willing to sign informed consent to participate in the substudy.
Exclusion Criteria1
- All exclusions for the receipt of rIL-2 on ESPRIT, 2. Known allergy to non-steroidal anti-inflammatory drugs (NSAIDS), opiates, 5HT-3 (serotonin-3) inhibitors, anti-dopaminergic antiemetics, or any other components of the proposed adjunct regimens.3. Use of other NSAIDS, cyclooxygenase-2 (COX-2) inhibitors, corticosteroids) or opiates analgesics within two weeks of rIL-2 dosing. Use of low dose aspirin as a cardio-protective agent is allowed.
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Interventions
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).
Locations(1)
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ACTRN12605000407695