title: Evaluation of cerebrospinal fluid virological escape in patients on long-term protease inhibitor monotherapy.
abstract: BACKGROUND
  A strategy of protease inhibitor (PI) monotherapy with re-introduction of triple therapy in those who rebound has been shown to be a safe and effective treatment simplification approach for long-term management. We sought evidence for cerebrospinal fluid (CSF) virological escape in patients on long-term PI monotherapy.
  
  
  METHODS
  We performed lumbar puncture in asymptomatic participants with suppressed plasma HIV RNA after 96 weeks on the PI monotherapy arm (PI-mono) of the PIVOT trial. We also report CSF HIV RNA concentration in trial participants who were investigated for neurological/neurocognitive symptoms during the trial regardless of study arm allocation.
  
  
  RESULTS
  All 11 asymptomatic participants on PI-mono who were tested had undetectable CSF HIV RNA at week 96. One of the three symptomatic participants on PI-mono had CSF HIV RNA of 1,895 copies/ml (undetectable in plasma) and neither of two symptomatic participants on triple therapy had CSF HIV RNA detected.
  
  
  CONCLUSIONS
  CSF virological escape appears rare in asymptomatic patients on PI monotherapy and may not warrant routine CSF monitoring, but patients with symptoms merit more concern.
authors.affiliation: MRC-Clinical Trials Unit at UCL, UCL, London, UK.|UCL Research Department of Infection and Population Health, UCL, London, UK.
authors.forename: Alejandro
authors.initials: A
authors.lastname: Arenas-Pinto
authors.affiliation: MRC-Clinical Trials Unit at UCL, UCL, London, UK.
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Stöhr
authors.affiliation: The Lawson Unit, Brighton and Sussex University Hospitals NHS Trust, Brighton, UK.
authors.forename: Amanda
authors.initials: A
authors.lastname: Clarke
authors.affiliation: UCL Research Department of Infection and Population Health, UCL, London, UK.
authors.forename: Ian
authors.initials: I
authors.lastname: Williams
authors.affiliation: Tropical & Infectious Disease Unit, Royal Liverpool University Hospital, Liverpool, UK.
authors.forename: Nicholas J
authors.initials: NJ
authors.lastname: Beeching
authors.affiliation: Infection and Travel Medicine Services, St James' University Hospital, Leeds, UK.
authors.forename: Jane
authors.initials: J
authors.lastname: Minton
authors.affiliation: The Northern Sexual Health, Contraception & HIV Service, Royal Infirmary, Manchester, UK.
authors.forename: Vincent
authors.initials: V
authors.lastname: Lee
authors.affiliation: MRC-Clinical Trials Unit at UCL, UCL, London, UK.|Yong Loo Lin School of Medicine, National University of Singapore, Singapore.
authors.forename: Nicholas I
authors.initials: NI
authors.lastname: Paton
mesh_terms: D023241:Antiretroviral Therapy, Highly Active; D002555:Cerebrospinal Fluid / Q000821:virology*; D005260:Female; D015658:HIV Infections / Q000134:cerebrospinal fluid* / Q000188:drug therapy / Q000821:virology*; D017320:HIV Protease Inhibitors / Q000627:therapeutic use; D006801:Humans; D012367:RNA, Viral; D013997:Time Factors; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D017320:HIV Protease Inhibitors; D012367:RNA, Viral