ESPRIT TOXIL-2 UNSW PSO 6361
- Conditions
- rlL-2 toxicityInterleukin-2 therapyHIVInfection - Acquired immune deficiency syndrome (AIDS / HIV)
- Registration Number
- ACTRN12605000407695
- Lead Sponsor
- niversity of New South Wales, Sydney, Australia.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 168
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.
1. 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of planned rIL-2 taken during the first rIL-2 dosing cycle while participating in this substudy. The information will be transcribed onto a standardised CRF.[Assessed at day 1 (day 1 of the dosing cycle of rIL-2), day 5 and day 10 by means of adherence assessment and patient diaries.]
- Secondary Outcome Measures
Name Time Method