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Hopes that intermittent antiretroviral therapy (ART) might keep patients healthy while limiting drug toxicities were dashed in early 2006, when the SMART trial closed prematurely (AIDS Clin Care Nov 29 2006). A safety analysis at the time found intermittent treatment to be associated with elevated rates of opportunistic disease and death. Study leaders urgently recommended that patients assigned to intermittent treatment resume continuous therapy. Follow-up on all participants continued for an additional 18 months and is now described in detail.
At the beginning of this final phase of the trial, 36% of the 2620 patients in the intermittent-therapy group were taking antiretrovirals, in contrast to 94% of the 2675 in the continuous-therapy gro…