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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00147355
Registration number
NCT00147355
Ethics application status
Date submitted
5/09/2005
Date registered
7/09/2005
Date last updated
12/04/2012
Titles & IDs
Public title
Toxicity Substudy of Evaluation of Subcutaneous Proleukin in a Randomised International Trial (ESPRIT): TOXIL-2 Substudy
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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
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Secondary ID [1]
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ACTR012605000407695
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Secondary ID [2]
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ESPRIT TOXIL-2 UNSW PSO 6361
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
HIV Infections
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Condition category
Condition code
Infection
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Acquired immune deficiency syndrome (AIDS / HIV)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - ondansetron, ibuprofen, paracetamol
Treatment: Drugs - Ondansetron, ibuprofen, paracetamol
Treatment: Drugs - metoclopramide, ibuprofen, paracetamol
Treatment: Drugs - Metoclopramide, codeine phosphate, ibuprofen, paracetamol
Other: A - Ondansetron 4mg bid + Ibuprofen 200mg qds + paracetamol 1g qds days 1-6 inclusive of rIL-2 dosing cycle
Other: B - Ondansetron 4mg bid + codeine phosphate 15mg tds + Ibuprofen 200mg qds + paracetamol 1g qds days 1-6 inclusive of rIL-2 dosing cycle
Other: D - metoclopramide 10mg qds + codeine phosphate 15mg tds + Ibuprofen 200mg qds + paracetamol 1g qds days 1-6 inclusive of rIL-2 dosing cycle
Other: C - metoclopramide 10mg qds + Ibuprofen 200mg qds + paracetamol 1g qds days 1-6 inclusive of rIL-2 dosing cycle
Treatment: Drugs: ondansetron, ibuprofen, paracetamol
ondansetron 4mg bid + Ibuprofen 200mg qds + paracetamol 1g qds days 1-6 inclusive of rIL-2 dosing cycle
Treatment: Drugs: Ondansetron, ibuprofen, paracetamol
Ondansetron 4mg bid + codeine phosphate 15mg tds + Ibuprofen 200mg qds + paracetamol 1g qds days 1-6 inclusive of rIL-2 dosing cycle
Treatment: Drugs: metoclopramide, ibuprofen, paracetamol
metoclopramide 10mg qds + Ibuprofen 200mg qds + paracetamol 1g qds days 1-6 inclusive of rIL-2 dosing cycle
Treatment: Drugs: Metoclopramide, codeine phosphate, ibuprofen, paracetamol
metoclopramide 10mg qds + codeine phosphate 15mg tds + Ibuprofen 200mg qds + paracetamol 1g qds days 1-6 inclusive of rIL-2 dosing cycle
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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percentage of planned rIL-2 taken during the first rIL-2 dosing cycle while participating in this substudy.
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Assessment method [1]
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we are comparing the percentage of planned rIL-2 taken when randomised to one of the four combinations used as adjunctive therapies to alleviate the known side-effects of rIL-2
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Timepoint [1]
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6 months
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Secondary outcome [1]
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Patterns of rIL-2 cycling frequency in the six months after randomisation into the substudy
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Assessment method [1]
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to explore the patterns of rIL-2 and see if the different adjuntive regimens increase tolerability such that more rIL-2 is taken
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Timepoint [1]
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6 months
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Secondary outcome [2]
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Percentage of planned rIL-2 taken during the cycles after the first cycle
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Assessment method [2]
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this is to assess whether the adjuncts to which the patient was randomised as part of this substudy impact on better tolerability of cycles of rIL-2 beyond the first
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Timepoint [2]
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6 mths
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Secondary outcome [3]
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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
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Assessment method [3]
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to see if the adjuncts to which the patient is randomised improve amount of rIL-2 taken compared to the cycle taken prior to enrollment in this substudy
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Timepoint [3]
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6 months
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Secondary outcome [4]
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Number of patients with dose modifications during the cycle due to toxicity
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Assessment method [4]
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to assess whether the adjuncts to which they were randomised reduced the amount of rIL-2 dose modification during the rIL-2 cycle
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Timepoint [4]
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6 months
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Secondary outcome [5]
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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
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Assessment method [5]
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to assess the impact of the randomised adjuntive agents on the predictable side-effects of rIL-2
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Timepoint [5]
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6 months
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Secondary outcome [6]
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Grade 1-4 creatinine and sodium changes during and after rIL-2 dosing;
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Assessment method [6]
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to assess the impact of the randomised adjuntive agents on the predictable effects of rIL-2 in regards to salt and water homeostasis and renal function
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Timepoint [6]
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6 months
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Secondary outcome [7]
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Changes in quality of life during and after rIL-2
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Assessment method [7]
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to assess whether the use of different adjunctive agents impacted on the tolerability of rIL-2 during the cycle and post as perceived by the patients qOL
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Timepoint [7]
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6 months
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Secondary outcome [8]
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Incidence of SAE and AE
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Assessment method [8]
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to assess the incidence of SAE and AEs that are rIL-2 (captured for the main study) and adjunctive agents
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Timepoint [8]
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6 months
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Factorial
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/2005
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2008
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Sample size
Target
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Accrual to date
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Final
28
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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St. Vincent's Hospital - Sydney
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Recruitment hospital [2]
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AIDS Medical Unit - Brisbane
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Recruitment hospital [3]
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Cairns Base Hospital - Cairns
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Recruitment hospital [4]
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Gold Coast Sexual Health Clinic - Gold Coast
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Recruitment hospital [5]
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Nambour Hospital - Nambour
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Recruitment hospital [6]
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Carlton Clinic - Melbourne
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Recruitment hospital [7]
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The Alfred Hospital - Melbourne
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Recruitment postcode(s) [1]
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2010 - Sydney
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Recruitment postcode(s) [2]
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4002 - Brisbane
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Recruitment postcode(s) [3]
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4870 - Cairns
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Recruitment postcode(s) [4]
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4220 - Gold Coast
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Recruitment postcode(s) [5]
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4560 - Nambour
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Recruitment postcode(s) [6]
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3000 - Melbourne
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Recruitment outside Australia
Country [1]
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Argentina
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State/province [1]
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Buenos Aires
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Country [2]
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Argentina
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State/province [2]
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La Plata
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Country [3]
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Argentina
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State/province [3]
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Mar del Plata
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Country [4]
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Argentina
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State/province [4]
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Mendoza
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Country [5]
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Argentina
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State/province [5]
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Rosario
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Country [6]
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Israel
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State/province [6]
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Rehovot
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Funding & Sponsors
Primary sponsor type
Government body
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Name
Kirby Institute
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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The University of New South Wales
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/study/NCT00147355
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Sarah L Pett, M.D
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Address
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Kirby Institute, Faculty of Medicine, University of New South Wales, Sydney, Australia
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT00147355
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