A Randomized Trial of Time-Limited Antiretroviral Therapy in Acute/Early HIV Infection

BackgroundIt has been proposed that initiation of antiretroviral treatment (ART) very soon after establishment of HIV infection may be beneficial by improving host control of HIV replication and delaying disease progression.MethodsPeople with documented HIV infection of less than 12 months’ duration in Baltimore MD and seven Canadian sites were randomized to either a) observation and deferred ART, or b) immediate treatment with ART for 12 months. All subjects not receiving ART were followed quarterly and permanent ART was initiated according to contemporaneous treatment guidelines. The endpoint of the trial was total ART-free time from study entry until initiation of permanent ART.ResultsOne hundred thirteen people were randomized, 56 to the observation arm and 57 to the immediate treatment arm. Twenty-three had acute (ConclusionsThis study did not find a benefit from administration of a brief, time-limited (12-month) course of ART in acute or early HIV infection.Trial RegistrationClinicalTrials.gov NCT00106171