Status:
TERMINATED
Toxicity Substudy of Evaluation of Subcutaneous Proleukin in a Randomised International Trial (ESPRIT): TOXIL-2 Substudy
Lead Sponsor:
Kirby Institute
Collaborating Sponsors:
The University of New South Wales
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 a...
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 predicta...
Eligibility Criteria
Inclusion
- Patients participating in ESPRIT and randomised to the rIL-2 arm, who:
- Are not at CD4+ T-cell target for the protocol
- Have not received rIL-2 for \> 2 months
- 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
- Are considered by the Investigator as medically safe to receive further dosing with rIL-2
- Are willing to receive further dosing with rIL-2 at the dose specified by the Investigator
- Are willing to sign informed consent to participate in the substudy
Exclusion
- All exclusions for the receipt of rIL-2 on ESPRIT
- 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.
- 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.
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00147355
Start Date
November 1 2005
End Date
December 1 2008
Last Update
April 12 2012
Active Locations (16)
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1
Hospital General de Agudos JM Ramos Mejia
Buenos Aires, Buenos Aires, Argentina, C221
2
FUNCEI
Buenos Aires, Buenos Aires, Argentina
3
Hospital Italiano de Buenos Aires
Buenos Aires, Buenos Aires, Argentina
4
Hospital Prof. Alejandro Posadas
Buenos Aires, Argentina