title: A randomized trial to evaluate lopinavir/ritonavir versus saquinavir/ritonavir in HIV-1-infected patients: the MaxCmin2 trial.
abstract: OBJECTIVE
  To assess the rate of protocol-defined treatment failure and safety of lopinavir/ritonavir (LPV/r) and saquinavir/ritonavir (SAQ/r).
  
  
  METHODS
  Open-label, prospective, randomized (1:1), international multi-centre trial.
  
  
  METHODS
  Adult HIV-1-infected patients were assigned LPV/r 400/100 mg twice daily or SAQ/r 1000/100 mg twice daily with two or more nucleoside reverse transcriptase inhibitors (NRTIs)/non-NRTIs. All patients, whether on or off the assigned treatment, were followed for 48 weeks.
  
  
  RESULTS
  Of 339 randomized patients, 324 initiated assigned treatment (intention-to-treat/exposed [ITT/e] population). At 48 weeks, treatment failure occurred in 29/163 (18%) and 53/161 (33%) of patients in the LPV/r and SAQ/r arms, respectively (ITT/e, P = 0.002, log rank test). In an analysis that also considered those patients who discontinued treatment as having failed treatment (ITT/e/discontinuation = failure), 40/161 (25%) LPV/r-treated individuals versus 63/161 (39%) SAQ/R-treated individuals failed treatment (P = 0.005, log rank test). Discontinuation of the assigned treatment occurred in 23/163 (14%) patients in the LPV/r-treated group, compared with 48/161 (300%) in the SAQ/r-treated group (ITT/e; P = 0.001). The primary reasons for premature discontinuation were non-fatal adverse events (LPV/r: 12/163; SAQ/r: 21/161) and patients' choice (LPV/r: 7/163; SAQ/r: 8/161). In the on-treatment analysis of time to treatment failure, no difference was observed between the two arms (P = 0.27, log rank test).
  
  
  CONCLUSIONS
  LPV/r had better antiretroviral effects compared with SAQ/r at the doses and in the formulations studied. This may have been a result of patients' preferences and ability to adhere to assigned therapy, rather than a result of differences in the intrinsic potency of the study protease inhibitors.
authors.affiliation: Hvidovre University Hospital, Copenhagen, Denmark. ubd@cphiv.dk
authors.forename: Ulrik B
authors.initials: UB
authors.lastname: Dragsted
authors.forename: Jan
authors.initials: J
authors.lastname: Gerstoft
authors.forename: Mike
authors.initials: M
authors.lastname: Youle
authors.forename: Zoe
authors.initials: Z
authors.lastname: Fox
authors.forename: Marcello
authors.initials: M
authors.lastname: Losso
authors.forename: Jorge
authors.initials: J
authors.lastname: Benetucci
authors.forename: Dushyantha T
authors.initials: DT
authors.lastname: Jayaweera
authors.forename: Armin
authors.initials: A
authors.lastname: Rieger
authors.forename: Johan N
authors.initials: JN
authors.lastname: Bruun
authors.forename: Antonella
authors.initials: A
authors.lastname: Castagna
authors.forename: Brian
authors.initials: B
authors.lastname: Gazzard
authors.forename: Sharon
authors.initials: S
authors.lastname: Walmsley
authors.forename: Andrew
authors.initials: A
authors.lastname: Hill
authors.forename: Jens D
authors.initials: JD
authors.lastname: Lundgren
mesh_terms: D000328:Adult; D004359:Drug Therapy, Combination; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000821:virology; D017320:HIV Protease Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D015497:HIV-1 / Q000187:drug effects; D006801:Humans; D061466:Lopinavir; D008297:Male; D008875:Middle Aged; D011744:Pyrimidinones / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D019438:Ritonavir / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D019258:Saquinavir / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D017320:HIV Protease Inhibitors; D011744:Pyrimidinones; D061466:Lopinavir; D019258:Saquinavir; D019438:Ritonavir