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

PHASE3TerminatedINTERVENTIONAL
Enrollment

28

Participants

Timeline

Start Date

November 30, 2005

Primary Completion Date

November 30, 2008

Study Completion Date

December 31, 2008

Conditions
HIV Infections
Interventions
DRUG

ondansetron, ibuprofen, paracetamol

ondansetron 4mg bid + Ibuprofen 200mg qds + paracetamol 1g qds days 1-6 inclusive of rIL-2 dosing cycle

DRUG

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

DRUG

metoclopramide, ibuprofen, paracetamol

metoclopramide 10mg qds + Ibuprofen 200mg qds + paracetamol 1g qds days 1-6 inclusive of rIL-2 dosing cycle

DRUG

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

Trial Locations (16)

2010

St. Vincent's Hospital, Sydney

3000

Carlton Clinic, Melbourne

The Alfred Hospital, Melbourne

4002

AIDS Medical Unit, Brisbane

4220

Gold Coast Sexual Health Clinic, Gold Coast

4560

Nambour Hospital, Nambour

4870

Cairns Base Hospital, Cairns

C221

Hospital General de Agudos JM Ramos Mejia, Buenos Aires

Unknown

FUNCEI, Buenos Aires

Hospital Italiano de Buenos Aires, Buenos Aires

Hospital Prof. Alejandro Posadas, Buenos Aires

Hospital Interzonal de Agudos San Juan de Dios, La Plata

Hospital Interzonal General de Agudos Oscar Alende, Mar del Plata

Hospital Central, Mendoza

CAICI, Rosario

Kaplan Medical Center, Rehovot

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

The University of New South Wales

OTHER

lead

Kirby Institute

OTHER_GOV