title: Short-course antiretroviral therapy in primary HIV infection.
abstract: BACKGROUND
  Short-course antiretroviral therapy (ART) in primary human immunodeficiency virus (HIV) infection may delay disease progression but has not been adequately evaluated.
  
  
  METHODS
  We randomly assigned adults with primary HIV infection to ART for 48 weeks, ART for 12 weeks, or no ART (standard of care), with treatment initiated within 6 months after seroconversion. The primary end point was a CD4+ count of less than 350 cells per cubic millimeter or long-term ART initiation.
  
  
  RESULTS
  A total of 366 participants (60% men) underwent randomization to 48-week ART (123 participants), 12-week ART (120), or standard care (123), with an average follow-up of 4.2 years. The primary end point was reached in 50% of the 48-week ART group, as compared with 61% in each of the 12-week ART and standard-care groups. The average hazard ratio was 0.63 (95% confidence interval [CI], 0.45 to 0.90; P=0.01) for 48-week ART as compared with standard care and was 0.93 (95% CI, 0.67 to 1.29; P=0.67) for 12-week ART as compared with standard care. The proportion of participants who had a CD4+ count of less than 350 cells per cubic millimeter was 28% in the 48-week ART group, 40% in the 12-week group, and 40% in the standard-care group. Corresponding values for long-term ART initiation were 22%, 21%, and 22%. The median time to the primary end point was 65 weeks (95% CI, 17 to 114) longer with 48-week ART than with standard care. Post hoc analysis identified a trend toward a greater interval between ART initiation and the primary end point the closer that ART was initiated to estimated seroconversion (P=0.09), and 48-week ART conferred a reduction in the HIV RNA level of 0.44 log(10) copies per milliliter (95% CI, 0.25 to 0.64) 36 weeks after the completion of short-course therapy. There were no significant between-group differences in the incidence of the acquired immunodeficiency syndrome, death, or serious adverse events.
  
  
  CONCLUSIONS
  A 48-week course of ART in patients with primary HIV infection delayed disease progression, although not significantly longer than the duration of the treatment. There was no evidence of adverse effects of ART interruption on the clinical outcome. (Funded by the Wellcome Trust; SPARTAC Controlled-Trials.com number, ISRCTN76742797, and EudraCT number, 2004-000446-20.).
authors: Sarah
authors: S
authors: Fidler
authors: Kholoud
authors: K
authors: Porter
authors: Fiona
authors: F
authors: Ewings
authors: John
authors: J
authors: Frater
authors: Gita
authors: G
authors: Ramjee
authors: David
authors: D
authors: Cooper
authors: Helen
authors: H
authors: Rees
authors: Martin
authors: M
authors: Fisher
authors: Mauro
authors: M
authors: Schechter
authors: Pontiano
authors: P
authors: Kaleebu
authors: Giuseppe
authors: G
authors: Tambussi
authors: Sabine
authors: S
authors: Kinloch
authors: Jose M
authors: JM
authors: Miro
authors: Anthony
authors: A
authors: Kelleher
authors: Myra
authors: M
authors: McClure
authors: Steve
authors: S
authors: Kaye
authors: Michelle
authors: M
authors: Gabriel
authors: Rodney
authors: R
authors: Phillips
authors: Jonathan
authors: J
authors: Weber
authors: Abdel
authors: A
authors: Babiker
mesh_terms: D000328:Adult; D044966:Anti-Retroviral Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D018791:CD4 Lymphocyte Count; D018450:Disease Progression; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006678:HIV / Q000235:genetics / Q000302:isolation & purification; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology; D006801:Humans; D008297:Male; D008875:Middle Aged; D012367:RNA, Viral / Q000097:blood; D055815:Young Adult
chemical_list: D044966:Anti-Retroviral Agents; D012367:RNA, Viral