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Whether asymptomatic human immunodeficiency virus (HIV)-infected patients can interrupt treatment remains unknown.We performed a prospective, observational study of 46 patients who started therapy with >300 CD4+ cells/mm3 and/or <70,0000 HIV-1 RNA copies/mL. Patients had been receiving highly active antiretroviral therapy (HAART) for at least 6 months. HAART was discontinued, and plasma HIV-1 RNA loads and CD4+ cell counts were determined at 4-month intervals.At the time of HAART discontinuation, the median CD4+ cell count was 793 cells/mm3, and all patients had undetectable viral loads. A rapid decrease of 173 cells/mm3 in the median CD4+ cell count was observed during the first 4 months after HAART was stopped, followed by a slower decrease of 234 cells/mm3 between months 5 and 20. The decrease in the median CD4+ cell count early after HAART discontinuation was inversely correlated with the increase that occurred during receipt of therapy (r = -0.653) and with the count at the time of HAART discontinuation (r = -0.589). The decrease in the median CD4+ cell count after the fourth month without HAART was correlated with the nadir count before HAART initiation (r = -0.349) and the increase during treatment (r = -0.322). The median follow-up duration was 20 months. After 12, 24, and 36 months of observation, 33 patients (71.7%), 22 patients (47.8%), and 16 patients (34.7%), respectively, remained free of therapy. Adverse clinical events were not seen, and all patients who reinitiated HAART responded rapidly.Selected asymptomatic HIV-infected patients can safely discontinue therapy for prolonged periods of time.