Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00147355
Status:
TERMINATED
Last Update Posted:
2012-04-12
First Post:
2005-09-05
Brief Title:
Toxicity Substudy of Evaluation of Subcutaneous Proleukin in a Randomised International Trial ESPRIT TOXIL-2 Substudy
Sponsor:
Kirby Institute
Organization:
Kirby Institute
Study Overview
Official 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
Status:
TERMINATED
Status Verified Date:
2012-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
28 of 168 patients only were enrolled numbers too low to be conclusive
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie ondansetron or metoclopramide with or without low dose codeine phosphate as an additional analgesic agent
Detailed Description:
The research is a randomised open-label substudy of ESPRIT The substudy is exploring whether the amount of rIL-2 taken during a dosing cycle of rIL-2 can be increased through controlling the predictable side-effects of rIL-2 better This is a four arm study with a factorial design patients will be randomised to one of four arms Each arm consists of different combinations of adjunctive agents Each patient will receive paracetamol and ibuprofen prophylactically throughout the cycle the other adjunctive agents prescribed will vary according to which arm the patient is randomised to but the antiemetic used will be either ondansetron or metoclopramide with or without low dose codeine phosphate as an additional analgesic agent The primary end-point is the percentage of planned rIL-2 actually taken during the cycle Secondary end-points include safety side-effects of rIL-2 and the adjunctive agents CD4 T-cell changes and quality of life measures
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ACTR012605000407695 | None | None | None |