title: CD4-guided scheduled treatment interruptions compared with continuous therapy for patients infected with HIV-1: results of the Staccato randomised trial.
abstract: BACKGROUND
  Stopping antiretroviral therapy in patients with HIV-1 infection can reduce costs and side-effects, but carries the risk of increased immune suppression and emergence of resistance.
  
  
  METHODS
  430 patients with CD4-positive T-lymphocyte (CD4) counts greater than 350 cells per muL, and viral load less than 50 copies per mL were randomised to continued therapy (n=146) or scheduled treatment interruptions (n=284). Median time on randomised treatment was 21.9 months (range 16.4-25.3). Primary endpoints were proportion of patients with viral load less than 50 copies per mL at the end of the trial, and amount of drugs used. Analysis was intention-to-treat. This study is registered at ClinicalTrials.gov with the identifier NCT00113126.
  
  
  RESULTS
  Drug savings in the scheduled treatment interruption group, compared with continuous treatment, amounted to 61.5%. 257 of 284 (90.5%) patients in the scheduled treatment interruption group reached a viral load less than 50 copies per mL, compared with 134 of 146 (91.8%) in the continued treatment group (difference 1.3%, 95% CI-4.3 to 6.9, p=0.90). No AIDS-defining events occurred. Diarrhoea and neuropathy were more frequent with continuous treatment; candidiasis was more frequent with scheduled treatment interruption. Ten patients (2.3%) had resistance mutations, with no significant differences between groups.
  
  
  CONCLUSIONS
  Drug savings with scheduled treatment interruption were substantial, and no evidence of increased treatment resistance emerged. Treatment-related adverse events were more frequent with continuous treatment, but low CD4 counts and minor manifestations of HIV infection were more frequent with scheduled treatment interruption.
authors.affiliation: HIV Netherlands Australia Thailand Research Collaboration, Bangkok, Thailand.
authors.forename: Jintanat
authors.initials: J
authors.lastname: Ananworanich
authors.forename: Angèle
authors.initials: A
authors.lastname: Gayet-Ageron
authors.forename: Michelle
authors.initials: M
authors.lastname: Le Braz
authors.forename: Wisit
authors.initials: W
authors.lastname: Prasithsirikul
authors.forename: Ploenchan
authors.initials: P
authors.lastname: Chetchotisakd
authors.forename: Sasisopin
authors.initials: S
authors.lastname: Kiertiburanakul
authors.forename: Warangkana
authors.initials: W
authors.lastname: Munsakul
authors.forename: Phitsanu
authors.initials: P
authors.lastname: Raksakulkarn
authors.forename: Somboon
authors.initials: S
authors.lastname: Tansuphasawasdikul
authors.forename: Sunee
authors.initials: S
authors.lastname: Sirivichayakul
authors.forename: Matthias
authors.initials: M
authors.lastname: Cavassini
authors.forename: Urs
authors.initials: U
authors.lastname: Karrer
authors.forename: Daniel
authors.initials: D
authors.lastname: Genné
authors.forename: Reto
authors.initials: R
authors.lastname: Nüesch
authors.forename: Pietro
authors.initials: P
authors.lastname: Vernazza
authors.forename: Enos
authors.initials: E
authors.lastname: Bernasconi
authors.forename: Dominic
authors.initials: D
authors.lastname: Leduc
authors.forename: Claudette
authors.initials: C
authors.lastname: Satchell
authors.forename: Sabine
authors.initials: S
authors.lastname: Yerly
authors.forename: Luc
authors.initials: L
authors.lastname: Perrin
authors.forename: Andrew
authors.initials: A
authors.lastname: Hill
authors.forename: Thomas
authors.initials: T
authors.lastname: Perneger
authors.forename: Praphan
authors.initials: P
authors.lastname: Phanuphak
authors.forename: Hansjakob
authors.initials: H
authors.lastname: Furrer
authors.forename: David
authors.initials: D
authors.lastname: Cooper
authors.forename: Kiat
authors.initials: K
authors.lastname: Ruxrungtham
authors.forename: Bernard
authors.initials: B
authors.lastname: Hirschel
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D023241:Antiretroviral Therapy, Highly Active / Q000009:adverse effects / Q000191:economics / Q000706:statistics & numerical data*; D018791:CD4 Lymphocyte Count; D004334:Drug Administration Schedule; D023381:Endpoint Determination; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology / Q000635:transmission; D015497:HIV-1; D006801:Humans; D008297:Male; D008875:Middle Aged