title: Episodic antiretroviral therapy increases HIV transmission risk compared with continuous therapy: results of a randomized controlled trial.
abstract: OBJECTIVE
  To compare the HIV transmission risk among patients randomized to episodic versus continuous antiretroviral therapy.
  
  
  METHODS
  This was a substudy of the Strategies of Management of Antiretroviral Therapy study, in which patients were randomized to continuous versus CD4-guided episodic antiretroviral therapy. Participants were surveyed about sexual activity and needle sharing and had laboratory testing for gonorrhea, chlamydia, and syphilis.
  
  
  RESULTS
  A total of 883 patients were enrolled in this study, the mean age of the patients was 45 years, 25% were women, and 78% were on antiretroviral therapy. At baseline, 136 participants (15.4%) had high-risk behavior (vaginal or anal sex without a condom, needle sharing, or incident bacterial sexually transmitted infection). After randomization, the proportion of participants reporting high-risk behavior was stable and did not differ by randomized arm (P = 0.39). Among participants off therapy at baseline, high-risk behavior was less common 4 months after randomization among those who were randomized to start antiretroviral therapy (P = 0.03). HIV transmission risk (high-risk behavior while HIV RNA level >1500 copies/mL) with partners perceived to be HIV uninfected was higher in the episodic therapy arm (P = 0.02).
  
  
  CONCLUSIONS
  Patients on episodic antiretroviral therapy did not decrease high-risk behavior, and because HIV RNA levels were higher, this strategy may result in increased HIV transmission.
authors.affiliation: Denver Public Health, 605 Bannock Street, Denver, CO 80204, USA. bburman@dhha.org
authors.forename: William
authors.initials: W
authors.lastname: Burman
authors.forename: Birgit
authors.initials: B
authors.lastname: Grund
authors.forename: Jacqueline
authors.initials: J
authors.lastname: Neuhaus
authors.forename: John
authors.initials: J
authors.lastname: Douglas
authors.forename: Gerald
authors.initials: G
authors.lastname: Friedland
authors.forename: Edward
authors.initials: E
authors.lastname: Telzak
authors.forename: Robert
authors.initials: R
authors.lastname: Colebunders
authors.forename: Nicholas
authors.initials: N
authors.lastname: Paton
authors.forename: Martin
authors.initials: M
authors.lastname: Fisher
authors.forename: Cornelis
authors.initials: C
authors.lastname: Rietmeijer