title: A Randomized Trial of Time-Limited Antiretroviral Therapy in Acute/Early HIV Infection.
abstract: BACKGROUND
  It 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.
  
  
  METHODS
  People 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.
  
  
  RESULTS
  One hundred thirteen people were randomized, 56 to the observation arm and 57 to the immediate treatment arm. Twenty-three had acute (<2 months) infection and 90 early (2-12 months) infection. Of those randomized to the immediate treatment arm, 37 completed 12 months of ART according to protocol, 9 declined to stop ART after 12 months, and 11 were nonadherent to the protocol or lost to follow-up. Comparing those in the observation arm to either those who completed 12 months of ART or all 56 who were randomized to immediate ART, there was no significant difference between the arms in treatment-free interval after study entry, which was about 18 months in both arms.
  
  
  CONCLUSIONS
  This study did not find a benefit from administration of a brief, time-limited (12-month) course of ART in acute or early HIV infection.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT00106171.
authors.affiliation: Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States of America.
authors.forename: Joseph B
authors.initials: JB
authors.lastname: Margolick
authors.affiliation: Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States of America.
authors.forename: Linda
authors.initials: L
authors.lastname: Apuzzo
authors.affiliation: CIHR Canadian HIV Trials Network, Vancouver, British Columbia, Canada.
authors.forename: Joel
authors.initials: J
authors.lastname: Singer
authors.affiliation: CIHR Canadian HIV Trials Network, Vancouver, British Columbia, Canada.
authors.forename: Hubert
authors.initials: H
authors.lastname: Wong
authors.affiliation: CIHR Canadian HIV Trials Network, Vancouver, British Columbia, Canada.
authors.forename: Terry
authors.initials: T
authors.lastname: Lee
authors.affiliation: Department of Medicine, Johns Hopkins School of Medicine, Baltimore, Maryland, United States of America.
authors.forename: Joel E
authors.initials: JE
authors.lastname: Gallant
authors.affiliation: Department of Medicine, McMaster University, Hamilton, Ontario Canada.
authors.forename: Phillippe
authors.initials: P
authors.lastname: El-Helou
authors.affiliation: Maple Leaf Medical Clinic, Toronto, Ontario, Canada.
authors.forename: Mona R
authors.initials: MR
authors.lastname: Loutfy
authors.affiliation: Sunnybrook Health Sciences, Toronto, Ontario, Canada.
authors.forename: Anita
authors.initials: A
authors.lastname: Rachlis
authors.affiliation: Cool Aid Community Health Center, Victoria, British Columbia, Canada.
authors.forename: Christopher
authors.initials: C
authors.lastname: Fraser
authors.affiliation: Department of Medical Microbiology, University of Manitoba, Winnipeg, Manitoba, Canada.
authors.forename: Kenneth
authors.initials: K
authors.lastname: Kasper
authors.affiliation: Centre de recherché du Centre Hospitalier de l' Université de Montréal, Montréal, Quebec, Canada.
authors.forename: Cécile
authors.initials: C
authors.lastname: Tremblay
authors.affiliation: Vancouver Infectious Diseases Centre, Vancouver, British Columbia, Canada.
authors.forename: Harout
authors.initials: H
authors.lastname: Tossonian
authors.affiliation: Vancouver Infectious Diseases Centre, Vancouver, British Columbia, Canada.
authors.forename: Brian
authors.initials: B
authors.lastname: Conway
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D023241:Antiretroviral Therapy, Highly Active; D018791:CD4 Lymphocyte Count; D005260:Female; D015658:HIV Infections / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality / Q000821:virology; D006801:Humans; D008297:Male; D008875:Middle Aged; D019233:Retreatment; D013997:Time Factors; D016896:Treatment Outcome; D019562:Viral Load; D055815:Young Adult