For immediate release
May 31, 2000

Announcement of Planning a Tri-National Clinical Trial to Determine Optimal Antiretroviral Therapy for HIV Infection

As the first effort under their new Tri-National Clinical Trials Research Initiative, national health research programs from three countries are developing an important clinical study for the treatment of AIDS. Three teams of researchers from US, the United Kingdom, and Canada will jointly develop an international study to determine the most effective treatment for persons with AIDS for whom all therapy has failed.

The use of combinations of antiretroviral drugs has dramatically improved survival and delayed progression to AIDS in recent years. Unfortunately, the benefits are only temporary for up to half of those affected because the potent drugs are poorly tolerated or their effectiveness is short-lived. An understanding of how to treat HIV-infected people for whom these drugs are no longer effective is critical. This large-scale study will be designed to evaluate optimal combinations of drug therapies in persons with AIDS for whom highly active antiretroviral therapy has failed. The planned study will also assess the effect that a temporary interruption in therapy may have on later re-treatment.

ìThis commitment to work together is an important step for clinical research as well as for these three world-class research organizations,î said Dr. John Feussner, Chief Research and Development Officer, Department of Veterans Affairs, the US agency involved with study development. ìIndividually, VA and our partners, the Medical Research Council of the United Kingdom (MRC-UK), and Medical Research Council of Canada (MRC-Canada) have a long and distinguished history of leadership in groundbreaking clinical research that has changed how medicine is practiced. The synergy of these three cooperating organizations will provide more rapid answers to critical clinical questions in the treatment of individuals with HIV disease.î

ìThis collaboration with VA, the MRC-UK and with our colleagues at Health Canada and the Canadian HIV Trials Network, will allow for faster and more reliable information about novel and effective therapies for treating HIV/AIDS and improving health outcomes,î said MRC-Canada President, Dr. Henry Friesen.

Added Dr. Peter Dukes, Director MRC-UK, Research Management Group, ìthe MRC-UK welcomes the opportunity to work in partnership with VA and MRC-Canada and looks forward to a successful and productive forum to encourage and develop international trials.î

If approved following scientific review, the study is planned for initiation in early 2001. Lead investigators on the study from VA include: Sheldon Brown, M.D., Chief of Infectious Disease Section, Bronx VA Medical Center, Mark Holodniy, M.D., Director of The HIV Research Center at the VA Palo Alto Health Care System, and Peter Peduzzi, Ph.D., Director of the West Haven, Connecticut, VA Cooperative Studies Program Coordinating Center; from MRC-Canada William Cameron, M.D., University of Ottawa, Martin Schechter, M.D., National Director, Canadian HIV Trials Network, and Joel Singer, Ph.D., Canadian HIV Trials Network; and from MRC-UK Abdel Babiker, Ph.D., Head, Division of HIV and Infections, MRC Clinical Trials Unit, Brian G. Gazzard, M.D., FRCP, HIV/GUM Research Director, Chelsea and Westminster Hospital, London, and Mike Youle, M.D., Director of HIV Clinical Research, Royal Free Center for HIV Medicine, London.

The study is part of the three countriesí Tri-National Clinical Trials Research Initiative. This initiative is designed to systematically identify clinical trials of high relevance to the health care missions of the VA, Canada and the United Kingdom. Benefits of this collaboration include more efficient patient recruitment, increased global application of results, minimization of duplicative research, and increased cost-efficiency for the conduct of large trials.

ìThis collaboration holds great promise for the future of clinical research and patient care,î said Dr. Feussner. ìIt is also a significant opportunity for the three countries to optimize their intellectual and fiscal resources to address global medical challenges in the 21st century.î

For additional information or to arrange an interview, contact:

Dan Bruneau or Karyn Cronin, VA R&D Communications, at (410) 962-1800, ext. 289 or 249, or Faye Kert, Medical Research Council of Canada, at (613) 946-0927. Additional assistance is available from Jim Blue, VA New York Regional Office of Public Affairs, at (212) 807-3429.

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