Toxicity Substudy of Evaluation of Subcutaneous Proleukin in a Randomised International Trial (ESPRIT): TOXIL-2 Substudy

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00147355
• Date of registration: 05/09/2005
• Primary sponsor: Kirby Institute
• Public title: Toxicity Substudy of Evaluation of Subcutaneous Proleukin in a Randomised International Trial (ESPRIT): TOXIL-2 Substudy
• Scientific title: 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
• Date of first enrolment: November 2005
• Target sample size: 28
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00147355
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Argentina, Australia, Israel

Contacts

• Name: Sarah L Pett, M.D
• Affiliation: Kirby Institute, Faculty of Medicine, University of New South Wales, Sydney, Australia

Key inclusion & exclusion criteria

Inclusion Criteria:

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 Criteria:

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 opiate
analgesics within two weeks of rIL-2 dosing. Use of low dose aspirin as a
cardio-protective agent is allowed.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

HIV Infections

Intervention(s)

Drug: Metoclopramide, codeine phosphate, ibuprofen, paracetamol

Drug: metoclopramide, ibuprofen, paracetamol

Drug: ondansetron, ibuprofen, paracetamol

Primary Outcome(s)

percentage of planned rIL-2 taken during the first rIL-2 dosing cycle while participating in this substudy. [Time Frame: 6 months]

Secondary Outcome(s)

Changes in quality of life during and after rIL-2 [Time Frame: 6 months]

Grade 1-4 creatinine and sodium changes during and after rIL-2 dosing; [Time Frame: 6 months]

Incidence of SAE and AE [Time Frame: 6 months]

Mean difference in rIL-2 taken during each cycle in the six-month period following randomisation into this substudy and rIL-2 uptake during the last dosing cycle immediately prior to participation in the substudy [Time Frame: 6 months]

Number of patients with dose modifications during the cycle due to toxicity [Time Frame: 6 months]

Number of patients with grade 1-4 constitutional upset (defined as any or all of the following: flu-like illness/fever/myalgia/arthralgia/headache) and/or GI upset and/or evidence of capillary leak syndromes [Time Frame: 6 months]

Patterns of rIL-2 cycling frequency in the six months after randomisation into the substudy [Time Frame: 6 months]

Percentage of planned rIL-2 taken during the cycles after the first cycle [Time Frame: 6 mths]

Secondary ID(s)

ACTR012605000407695

ESPRIT TOXIL-2 UNSW PSO 6361

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

The University of New South Wales