The Strategic Timing of AntiRetroviral Treatment (START) trial (conducted by the INSIGHT network) is an international randomized trial to determine whether starting antiretroviral therapy (ART) early rather than waiting until CD4 drops below 350 cells reduces the occurrence of serious morbidity and mortality. START enrolled 4,686 HIV-positive participants at 215 clinics in 35 countries around the world from 2009 to 2013. In May 2015 at a planned interim review, START’s Data and Safety Monitoring Board (DSMB) informed NIAID and START leadership that the question posed by START had been answered. The study team was informed of the results of the trial: starting ART while CD4 is still above 500 cells/mm3 is superior to deferral to 350 cells/mm3. The DSMB recommended that study participants not yet taking ART be offered the opportunity to start therapy and that follow-up continue. START investigators will follow participants until the end of  2021 and report findings in 2022-2023.

Initial findings from START led to worldwide changes in HIV/AIDS treatment guidelines -- now recommending that an individual begin ART upon diagnosis of having HIV.

Further reading:

INSIGHT START Study Group. Initiation of antiretroviral therapy in early asymptomatic HIV Infection. N Engl J Med 2015; 373:795-807.

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