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Sponsors and Collaborators: |
The National Centre in HIV Epidemiology and Clinical Research The University of New South Wales |
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Information provided by: | The National Centre in HIV Epidemiology and Clinical Research |
ClinicalTrials.gov Identifier: | NCT00147355 |
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.
Condition | Intervention | Phase |
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HIV Infections |
Drug: Metoclopramide Drug: Ondansetron Drug: Paracetamol Drug: Codeine phosphate Drug: Ibuprofen |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study |
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 |
Estimated Enrollment: | 168 |
Study Start Date: | November 2005 |
Estimated Study Completion Date: | September 2007 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients participating in ESPRIT and randomised to the rIL-2 arm, who:
Exclusion Criteria:
Argentina | |
Hospital Interzonal General de Agudos Oscar Alende | |
Mar del Plata, Argentina | |
Hospital Prof. Alejandro Posadas | |
Buenos Aires, Argentina | |
CAICI | |
Rosario, Argentina | |
Hospital Interzonal de Agudos San Juan de Dios | |
La Plata, Argentina | |
FUNCEI | |
Buenos Aires, Argentina | |
Hospital General de Agudos JM Ramos Mejia | |
Buenos Aires, Argentina, C221 | |
Hospital Italiano de Buenos Aires | |
Buenos Aires, Argentina | |
Hospital Central | |
Mendoza, Argentina | |
Australia, New South Wales | |
St. Vincent's Hospital | |
Sydney, New South Wales, Australia, 2010 | |
Australia, Queensland | |
Nambour Hospital | |
Nambour, Queensland, Australia, 4560 | |
AIDS Medical Unit | |
Brisbane, Queensland, Australia, 4002 | |
Gold Coast Sexual Health Clinic | |
Gold Coast, Queensland, Australia, 4220 | |
Cairns Base Hospital | |
Cairns, Queensland, Australia, 4870 | |
Australia, Victoria | |
The Alfred Hospital | |
Melbourne, Victoria, Australia, 3000 | |
Carlton Clinic | |
Melbourne, Victoria, Australia, 3000 | |
Israel | |
Kaplan Medical Center | |
Rehovot, Israel |
Principal Investigator: | Sarah L Pett, M.D | National Centre in HIV Epidemiology and Clinical Research, Faculty of Medicine, University of New South Wales, Sydney, Australia |
Study ID Numbers: | ESPRIT TOXIL-2 UNSW PSO 6361, ACTR012605000407695 |
Study First Received: | September 5, 2005 |
Last Updated: | January 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00147355 History of Changes |
Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration; Israel: Israeli Health Ministry Pharmaceutical Administration; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; United States: Food and Drug Administration |
rIL-2-toxicity interleukin-2 therapy HIV Toxicity substudy of ESPRIT |
Neurotransmitter Agents Sexually Transmitted Diseases, Viral Psychotropic Drugs Antiemetics Metoclopramide Naphazoline Dopamine Antipruritics Ondansetron Analgesics Phenylpropanolamine Retroviridae Infections Acetaminophen Analgesics, Opioid Ibuprofen |
Tranquilizing Agents Acquired Immunodeficiency Syndrome Central Nervous System Depressants Narcotics Antipsychotic Agents Serotonin Codeine Immunologic Deficiency Syndromes Virus Diseases Aldesleukin HIV Infections Interleukin-2 Analgesics, Non-Narcotic Guaifenesin Sexually Transmitted Diseases |
Respiratory System Agents Neurotransmitter Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Antiemetics Infection Metoclopramide Serotonin Antagonists Sensory System Agents Therapeutic Uses Antipruritics Ondansetron |
Analgesics Dermatologic Agents Retroviridae Infections Acetaminophen Analgesics, Opioid RNA Virus Infections Tranquilizing Agents Immune System Diseases Acquired Immunodeficiency Syndrome Gastrointestinal Agents Central Nervous System Depressants Dopamine Antagonists Narcotics Antipsychotic Agents Immunologic Deficiency Syndromes |