Halting Of All Clinical Trials Of Interleukin-2 For HIV-AIDS Recommended

Main Category: HIV / AIDS
Also Included In: Clinical Trials / Drug Trials
Article Date: 16 Oct 2009 - 4:00 PDT

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An international research team has demonstrated that treating HIV-AIDS with interleukin-2 (IL-2) is ineffective. As a result, the researchers recommend that clinical trials on this compound be stopped. Their finding was published in the New England Journal of Medicine in an article co-authored by 14 researchers, including Dr. Jean-Pierre Routy of the Research Institute of the McGill University Health Centre (RI-MUHC).

IL-2 is currently used as a complement to highly active antiretroviral therapy (known as HAART), which is administered to patients with HIV-AIDS. Since HAART controls replication of viruses in the blood, doctors thought that IL-2 would help regenerate more CD4+ immune cells, which serve as an indicator of viral progression. It was thought that IL-2 increased the natural immunity of patients by helping immune cells mature and multiply.

"Our results show that IL-2 has no effect on the development of AIDS or on patient survival," says Dr. Routy. "More precisely, while the presence of IL-2 leads to a faster increase of CD4+ immune cells, these cells are less functional than the CD4+ cells that regenerate naturally in patients who do not receive IL-2. This means that IL-2 treatment provides no benefit and does not prevent AIDS-related infectious diseases."

"For the first time, a study has shed light on recurring questions concerning the value of biological markers and their limitations in assessing patient health," explains Dr. Routy. "Our challenge now will be to develop tests that assess the function of immune cells and not simply their quantity. This will ensure that HIV treatments indeed have a clinical benefit for patients."

This 8-year study involved over 5000 patients in 25 countries, and was one of the largest ever conducted on HIV-AIDS. "The fact that data from developing countries was used in biomedical research on innovative compounds is very revolutionary in the history of HIV-AIDS research," explains Dr. Routy.

Dr. Jean-Pierre Routy is a physician in the Division of Hematology and Immunodeficiency at the MUHC as well as a researcher in the Infection and Immunity Axis at the Research Institute of the MUHC. He is also an Associate Professor of Hematology at McGill University and a senior clinical researcher with the Fonds de la recherche en santé du Québec (FRSQ).

Funding:
This study was funded by a grant from the National Institutes of Health (NIH)

Partners:
This article was co-authored by Dr. D. Abrams, University of California, San Francisco; Dr. Y. Lévy, INSERM U955, Université Paris 12, et Assistance Publique-Hôpitaux de Paris, Groupe Henri-Mondor Albert-Chenevier, Dr. M.H. Losso, Hospital General de Agudos, Dr. J.M. Ramos Mejia, Buenos Aires; Dr. A. Babiker, Medical Research Council, London; Dr. G. Collins, University of Minnesota, Minneapolis; Dr. D. Cooper, National Centre in HIV Epidemiology and Clinical Research, Sydney; Dr. J. Darbyshire, Medical Research Council, London; Dr. S. Emery, National Centre in HIV Epidemiology and Clinical Research, Sydney; Dr. L. Fox, National Institute of Allergy and Infectious Diseases, Bethesda; Dr. F. Gordin, Washington Veterans Medical Center, Washington, DC; Dr. H.C. Lane, National Institutes of Health, Bethesda; Dr. J.D. Lundgren, Rigshospitalet & University of Copenhagen, Copenhagen; Dr. R. Mitsuyasu, University of California, Los Angeles; Dr. J.D. Neaton, University of Minnesota, Minneapolis; Dr. A. Phillips, University College London Medical School, London; Dr. J.P Routy, Royal Victoria Hospital, McGill University Health Centre; Dr. G. Tambussi, Fondazione San Raffaele del Monte Tabor, Milano; Dr. D. Wentworth, University of Minnesota, Minneapolis.

Source:
Julie Robert
McGill University Health Centre