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The SMART study randomized 5,472 human immunodeficiency virus (HIV)-infected patients with CD4+ cell counts &gt;350 cells/microL to intermittent antiretroviral therapy (ART; the drug conservation [DC] group) versus continuous ART (the viral suppression [VS] group). In the DC group, participants started ART when the CD4+ cell count was &lt;250 cells/microL. Clinical outcomes in participants not receiving ART at entry inform the early use of ART.

Major Clinical Outcomes in Antiretroviral Therapy (ART)–Naive Participants and in Those Not Receiving ART at Baseline in the SMART Study