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The best approach to managing patients with recently acquired HIV infection has remained elusive. Should these patients start antiretroviral therapy (ART) immediately, regardless of CD4-cell count, or wait until they meet standard criteria? Data from a large ACTG trial of short-term ART during early infection (the Setpoint Study) provide some answers.
Adults with early (but not acute) HIV infection were randomized to a 36-week course of ART followed by treatment discontinuation or to observation only. In both groups, patients were advised to start (or restart) long-term, continuous ART if they met prespecified criteria for treatment initiation (e.g., a CD4 count <350 cells/mm3).
After 130 of a planned 150 patients had been enrolled (and 79 ha…