Researchers from the United States, Canada and the United Kingdom are collaborating to evaluate the best treatment strategies for HIV-infected patients for whom highly active antiretroviral therapy has failed.
Representatives of the U.S. Department of Veterans Affairs (VA), the Canadian Institutes of Health Research (CIHR) and the Medical Research Council of the United Kingdom (MRC-UK) are meeting today through Friday in Washington to complete details of a study that will begin June 1.
The study, called OPTIMA, will be the first under the three countries' Tri-National Clinical Trials Research Initiative. It will assess new therapeutic strategies in persons with AIDS for whom antiretroviral therapy has failed. In recent years, combinations of antiretroviral drugs have dramatically improved survival and delayed progression from HIV infection to AIDS. Unfortunately, the benefits are only temporary for up to half of those treated.
"One of the highest priorities in HIV medicine today is to learn how to optimize the use of these powerful drugs," said Dr. John R. Feussner, VA's chief research and development officer. "The clinicians, researchers, and the leadership of these three governmental agencies recognize we are in a unique position to help answer this important question for persons with HIV infection".
To address the question, researchers will test new strategies for the use of medicines available to treat HIV infection. They will also test whether pauses in anti-retroviral treatment of an intended duration of three months will allow patients to recover enough from side effects to better tolerate the new therapy and whether the virus will become more sensitive to the drugs. AIDS-related events and deaths will be a major focus of the research. Researchers will also evaluate quality-of-life issues, health care resource use and cost effectiveness. The final research protocol will involve approximately 1,700 patients at more than 70 sites over three and a half years.
"The latest AIDS drugs have been a quantum leap forward, but regrettably many people are starting to lose the benefit of these drugs," said CIHR president, Dr. Alan Bernstein. "This tri-national collaborative clinical trial will address the increasingly pressing question of how to best treat people for whom all our available drug cocktails have failed."
Sir George Radda, MRC Chief Executive said: "This is an unprecedented collaboration that will strengthen international HIV research and should enable us to create better tailored healthcare for those living with HIV and AIDS. OPTIMA is the first trial funded under this important initiative to make the best possible use of resources across the globe, to tackle health problems as quickly and efficiently as possible, and to set new global standards in healthcare."
Researchers on the study include: Sheldon Brown, M.D., Chief of the Infectious Disease Section, Bronx VA Medical Center; Mark Holodniy, M.D., Director of the HIV Research Center at the VA's Palo Alto (Calif.) Health Care System; Tassos C. Kyriakides, Ph.D., VA Cooperative Studies Program Coordinating Center, West Haven, Conn.; Doug Owens, M.D., VA's Palo Alto (Calif.) Health Care System; William Cameron, M.D., University of Ottawa; Joel Singer, Ph.D., Canadian HIV Trials Network; Aslam Anis, Ph.D., Program Head, Pharmacoeconomics, Canadian HIV Trials Network; Brian Gazzard, M.D., FRCP, HIV/GUM Research Director, Chelsea and Westminster Hospital, London; Mike Youle, M.D., Director of HIV Clinical Research, Royal Free Center for HIV Medicine, London; Abdel Babiker, Ph.D., Head, Division of HIV and Infections, MRC-UK Clinical Trials Unit, and Mark Sculpher, Ph.D., MRC-UK Clinical Trials Unit.
Co-chairs of the Trial Management Committee will be: Martin Schechter, M.D., National Director, Canadian HIV Trials Network; Lawrence R. Deyton, M.D., Chief Consultant, Public Health Strategic Healthcare Group, U.S. Department of Veterans Affairs; and Janet Darbyshire, M.D., FRCP, Director of the MRC-UK Clinical Trials Unit.