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Individuals infected with HIV should start antiretroviral therapy (ART) at diagnosis to lower their risk of developing AIDS or other health issues related to HIV infection, according to findings from an interim review of the first large-scale randomized clinical trial of early treatment, the Strategic Timing of Antiretroviral Treatment (START) trial, (http://1.usa.gov/1cZVa0l). The START study was initiated in 2009 to determine the most propitious point at which to begin ART for HIV—either early in the course of infection, when the CD4+ cell count is greater than 500 cells/mm3, or later, when it drops below 350 cells/mm3.
The study enrolled 4685 adults living with HIV infection in 35 countries on 6 continents. The participants, who had never taken ART therapy and had CD4+ counts above 500 cells/mm3, were randomly assigned to either begin ART immediately or to hold off treatment until their CD4+ cell count decreased to 350 cells/mm3.
An independent data and safety monitoring board reviewed preliminary interim results of the trial from March and recommended early release of results showing those who received early treatment had a 53% lower risk of serious illness or death compared with those in the deferred-treatment group. Consequently, all participants in the trial who were not receiving ART will be offered treatment, and their clinical course followed through 2016.