title: Randomized controlled trial of once-daily tenofovir, lamivudine, and lopinavir/ritonavir versus remaining on the same regimen in virologically suppressed HIV-infected patients on their first PI-containing HAART regimen.
abstract: OBJECTIVE
  To assess the effects of switching to once-daily (QD) lopinavir/ritonavir (LPV/r)-based combination therapy in HIV-infected patients who are virologically suppressed (HIV viral load <50 copies/mL) on their first protease inhibitor (PI)-containing regimen.
  
  
  METHODS
  In this 48-week, prospective, open-label, randomized study, patients were either switched to once-daily LPV/r, tenofovir (TDF), and lamivudine (3TC) (QD arm) or remained on their existing regimen (control arm). The primary endpoint of the study was the proportion of patients maintaining virologic suppression following 48 weeks of treatment.
  
  
  RESULTS
  Fifty and 22 patients were randomized to the QD and control arms, respectively. At week 48, there was no significant difference in virological suppression between the QD and control arms using intent-to-treat (missing = failure) analysis (p = .44). There was no significant difference in discontinuation rates between the two arms (p = .66). Significantly more patients randomized to the QD arm reported gastrointestinal adverse events compared with the control arm (p = .009). There were no study drug-related serious adverse events.
  
  
  CONCLUSIONS
  For patients who are already virologically suppressed on their first PI-containing regimen, switching to a QD regimen of TDF+3TC+LPV/r resulted in similar rates of virologic suppression when compared with staying on existing therapy.
authors.affiliation: Department of Medicine, University of Toronto, Toronto, Canada.
authors.forename: Mona R
authors.initials: MR
authors.lastname: Loutfy
authors.forename: Nabil
authors.initials: N
authors.lastname: Ackad
authors.forename: Tony
authors.initials: T
authors.lastname: Antoniou
authors.forename: Jean-Guy
authors.initials: JG
authors.lastname: Baril
authors.forename: Brian
authors.initials: B
authors.lastname: Conway
authors.forename: Joss
authors.initials: J
authors.lastname: de Wet
authors.forename: Benoit
authors.initials: B
authors.lastname: Trottier
authors.forename: Colin M
authors.initials: CM
authors.lastname: Kovacs
authors.forename: William
authors.initials: W
authors.lastname: Thompson
authors.forename: Alain Y
authors.initials: AY
authors.lastname: Martel
authors.forename: Sylvie
authors.initials: S
authors.lastname: Trottier
authors.forename: Danielle
authors.initials: D
authors.lastname: Rouleau
authors.forename: Stephen D
authors.initials: SD
authors.lastname: Shafran
authors.forename: Anita
authors.initials: A
authors.lastname: Rachlis
authors.forename: Christopher
authors.initials: C
authors.lastname: Fraser
authors.forename: Fiona
authors.initials: F
authors.lastname: Smaill
authors.forename: Sharon L
authors.initials: SL
authors.lastname: Walmsley
authors.forename: Alice L
authors.initials: AL
authors.lastname: Tseng
authors.forename: John S
authors.initials: JS
authors.lastname: Sampalis
mesh_terms: D000225:Adenine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000328:Adult; D023241:Antiretroviral Therapy, Highly Active; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D017320:HIV Protease Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D019259:Lamivudine / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D061466:Lopinavir; D008297:Male; D008875:Middle Aged; D063065:Organophosphonates / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D011744:Pyrimidinones / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D019438:Ritonavir / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D000068698:Tenofovir; D019562:Viral Load
chemical_list: D017320:HIV Protease Inhibitors; D063065:Organophosphonates; D011744:Pyrimidinones; D061466:Lopinavir; D019259:Lamivudine; D000068698:Tenofovir; D000225:Adenine; D019438:Ritonavir