Abstract

Abstract With advances in treatment, human immunodeficiency virus (HIV) can be managed as a chronic disease. However, prior to 2015, there was little data about the timing of starting antiretroviral therapy (ART) for patients with CD4+ counts >500 cells per cubic millimeter. The START trial randomized patients into immediate initiation of ART at diagnosis or deferred initiation of ART until CD4+ counts were less than 350 cells/mm3, or the patient developed an AIDS-defining condition or another condition requiring the initiation of treatment. The primary endpoint of the study was a composite of HIV-related illness, other illness, and mortality. The trial was stopped early based on interim analyses with the conclusion that immediate initiation of antiretroviral combination therapy for persons diagnosed with HIV, regardless of CD4+ count, provided benefits in terms of health outcomes.

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