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To evaluate the safety of treatment interruption guided by CD4+ cell count in HIV-infected patients followed up prospectively.Patients on highly active antiretroviral therapy with CD4+ cell counts > 500 × 106 cells/l discontinued therapy with instructions to start therapy again before their CD4+ count dropped below 200 × 106 cells/l. Any patients who resumed therapy would be eligible to interrupt treatment again once their CD4+ cell count increased above 500 × 106 cells/l.Data on 71 HIV infected patients is reported. Their median nadir CD4+ cell count before antiretroviral treatment was 352 × 106 cells/l [interquartile range (IQR), 294–445 × 106 cells/l]. The median CD4+ cell count at the time of first interruption was 790 × 106 cells/l (IQR, 657–1041 × 106 cells/l). The median follow-up after starting the first treatment interruption was 28.3 months (IQR, 21.4–37.0 months).During the follow-up 49 patients restarted therapy and 22 patients remain off therapy; 24 patients have interrupted therapy twice, nine patients have interrupted therapy three times and six patients four times. No AIDS-defining illnesses occurred during the follow-up. The median duration of the first interruption was 15 months (IQR, 6–26 months). The overall reduction of time on therapy was 71.1%. The duration of the first interruption and the reduction of time on therapy were related to nadir CD4+ cell count. The patients who resumed HAART rapidly regained CD4+ cells and achieved viral suppression.If carefully monitored, treatment interruptions guided by CD4+ cell count in patients with an initially high CD4+ cell counts are clinically safe, decrease exposure to the drugs and do not reduce the efficacy of therapy when this is re-started.