By Karla Gale
NEW YORK (Reuters Health) – The US National Institute of Allergy and Infectious Diseases announced today its sponsorship of the first study that will assess the outcome of two different approaches to HIV antiretroviral therapy after a prolonged period. The Strategies for Management of Anti-Retroviral Therapies (SMART) study will eventually enroll 6000 individuals who will be followed for an average of 7 years.
HIV-infected patients will be randomly assigned to one of two strategies. The traditional "hit-hard-early" strategy will begin treatment early after infection with the objective of maintaining HIV levels as low as possible.
The other strategy will delay antiretroviral treatment until CD4+ counts decline below 250 cells per µL. After CD4+ counts rebound above 350 cells per µL, the patients will interrupt treatment.
Dr. Wadaa El-Sadr, of Columbia University in New York and co-director of the trial, said in an interview with Reuters Health, "Previous research has shown that generally the risk of complications associated with HIV increases only when CD4+ counts drop below 150. So a cut-off of 250 provides a nice safety cushion.
"It might be that people can be off treatment for quite a long time," she added, "but we don't know."
The investigators, located at 21 sites in the US and several in Australia, will examine treatment effects on the heart, body fat distribution, and bone density.
"The drugs to be used will be decided by patients' primary care physicians," Dr. Karin Klingman, of the NIAID in Bethesda, Maryland, told Reuters Health.
Dr. Klingman added that patients at any stage of infection or treatment will be enrolled and then randomized to a treatment group. Also, she said, "7 years is only an estimate of how long the study will last. It will actually be protocol-driven by temporal end points, deaths and serious illness."
"I think this fundamentally is a completely new kind of study, Dr. El-Sadr added. "It signifies the maturation of the HIV epidemic, where up until now, we had to think primarily about patient survival. Now we know we'll be following these patients for 10 or 20 years, so we need to consider what will be best for them over the long-term."