title: Antiretroviral therapy in acute and recent HIV infection: a prospective multicenter stratified trial of intentionally interrupted treatment.
abstract: BACKGROUND
  Antiretroviral therapy in early HIV infection may enhance outcome and viral control may be better in acute versus recent infection 24 weeks after treatment interruption.
  
  
  METHODS
  A prospective trial of treatment stratified by acute versus recent HIV-1 infection. If HIV viral load <50 copies/ml after at least 52 weeks, treatment was interrupted. If viremia rebounded, treatment and interruption were repeated. The primary endpoint was maintaining viral load less than 5000 copies/ml for 24 weeks following treatment interruption.
  
  
  RESULTS
  Of the 121 patients enrolled at 15 sites, ninety-five percent were men, median age was 34 years; 69% were white. Median viral load was higher in acute HIV-1 infection (210 000 copies/ml) than recent HIV-1 infection (43 000 copies/ml). The 73 primary endpoint patients (28 acute HIV-1 infection, 45 recent HIV-1 infection) had significantly higher baseline CD4 T-cell counts (P = 0.044) and lower viral load (P = 0.016). The primary endpoint was achieved in 29 (40%) of the 73 and in 24% of the 121 enrolled overall. There was no significant outcome difference (P = 0.81) between the acute HIV-1 infection [43%, 95% confidence interval (CI) 24-63%] and recent HIV-1 infection (38%, 95% CI 24-53%) groups. Differences after longer follow-up can not be ascertained by this trial. Baseline viral load less than 100 000/ml 22/46 (48%) compared with more than 100 000/ml, 7/27 (26%) and higher baseline CD4 immune activation predicted success.
  
  
  CONCLUSIONS
  Forty percent of patients treated during acute HIV-1 infection or recent HIV-1 infection sustained a viral load less than 5000 copies/ml after 24 weeks of treatment interruption.
authors.affiliation: University of California-San Francisco, 4150 Clement Street, San Francisco, CA 94121, USA. Paul.volberding@va.gov
authors.forename: Paul
authors.initials: P
authors.lastname: Volberding
authors.forename: Lisa
authors.initials: L
authors.lastname: Demeter
authors.forename: Ronald J
authors.initials: RJ
authors.lastname: Bosch
authors.forename: Evgenia
authors.initials: E
authors.lastname: Aga
authors.forename: Carla
authors.initials: C
authors.lastname: Pettinelli
authors.forename: Martin
authors.initials: M
authors.lastname: Hirsch
authors.forename: Mary
authors.initials: M
authors.lastname: Vogler
authors.forename: Ana
authors.initials: A
authors.lastname: Martinez
authors.forename: Susan
authors.initials: S
authors.lastname: Little
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Connick
mesh_terms: D000208:Acute Disease; D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D023241:Antiretroviral Therapy, Highly Active / Q000379:methods; D018791:CD4 Lymphocyte Count; D004334:Drug Administration Schedule; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology / Q000821:virology; D015497:HIV-1 / Q000302:isolation & purification*; D006801:Humans; D008297:Male; D011446:Prospective Studies; D012367:RNA, Viral / Q000097:blood; D016896:Treatment Outcome; D019562:Viral Load; D014766:Viremia / Q000188:drug therapy / Q000821:virology
chemical_list: D019380:Anti-HIV Agents; D012367:RNA, Viral
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