title: A randomized, controlled, trial of short cycle intermittent compared to continuous antiretroviral therapy for the treatment of HIV infection in Uganda.
abstract: BACKGROUND
  Short cycle treatment interruption could reduce toxicity and drug costs and contribute to further expansion of antiretroviral therapy (ART) programs.
  
  
  METHODS
  A 72 week, non-inferiority trial enrolled one hundred forty six HIV positive persons receiving ART (CD4+ cell count > or =125 cells/mm(3) and HIV RNA plasma levels <50 copies/ml) in one of three arms: continuous, 7 days on/7 days off and 5 days on/2 days off treatment. Primary endpoint was ART treatment failure determined by plasma HIV RNA level, CD4+ cell count decrease, death attributed to study participation, or opportunistic infection.
  
  
  RESULTS
  Following enrollment of 32 participants, the 7 days on/7 days off arm was closed because of a failure rate of 31%. Six of 52 (11.5%) participants in the 5 days on/2 days off arm failed. Five had virologic failure and one participant had immunologic failure. Eleven of 51 (21.6%) participants in the continuous treatment arm failed. Nine had virologic failure with 1 death (lactic acidosis) and 1 clinical failure (extra-pulmonary TB). The upper 97.5% confidence boundary for the difference between the percent of non-failures in the 5 days on/2 days off arm (88.5% non-failure) compared to continuous treatment (78.4% non failure) was 4.8% which is well within the preset non-inferiority margin of 15%. No significant difference was found in time to failure in the 2 study arms (p = 0.39).
  
  
  CONCLUSIONS
  Short cycle 5 days on/2 days off intermittent ART was at least as effective as continuous therapy.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT00339456.
authors.affiliation: National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, United States of America. sjr@jhmi.edu
authors.forename: Steven J
authors.initials: SJ
authors.lastname: Reynolds
authors.forename: Cissy
authors.initials: C
authors.lastname: Kityo
authors.forename: Claire W
authors.initials: CW
authors.lastname: Hallahan
authors.forename: Geoffrey
authors.initials: G
authors.lastname: Kabuye
authors.forename: Diana
authors.initials: D
authors.lastname: Atwiine
authors.forename: Frank
authors.initials: F
authors.lastname: Mbamanya
authors.forename: Francis
authors.initials: F
authors.lastname: Ssali
authors.forename: Robin
authors.initials: R
authors.lastname: Dewar
authors.forename: Marybeth
authors.initials: M
authors.lastname: Daucher
authors.forename: Richard T
authors.initials: RT
authors.lastname: Davey
authors.forename: Peter
authors.initials: P
authors.lastname: Mugyenyi
authors.forename: Anthony S
authors.initials: AS
authors.lastname: Fauci
authors.forename: Thomas C
authors.initials: TC
authors.lastname: Quinn
authors.forename: Mark R
authors.initials: MR
authors.lastname: Dybul
mesh_terms: D000328:Adult; D044966:Anti-Retroviral Agents / Q000008:administration & dosage*; D018791:CD4 Lymphocyte Count; D004334:Drug Administration Schedule; D005260:Female; D015658:HIV Infections / Q000150:complications / Q000188:drug therapy* / Q000401:mortality; D006801:Humans; D008297:Male; D008875:Middle Aged; D009894:Opportunistic Infections; D012367:RNA, Viral / Q000097:blood; D017211:Treatment Failure; D016896:Treatment Outcome; D014454:Uganda; D019562:Viral Load / Q000187:drug effects / Q000379:methods
chemical_list: D044966:Anti-Retroviral Agents; D012367:RNA, Viral