title: Randomized trial to evaluate indinavir/ritonavir versus saquinavir/ritonavir in human immunodeficiency virus type 1-infected patients: the MaxCmin1 Trial.
abstract: This trial assessed the rate of virological failure at 48 weeks in adult human immunodeficiency virus (HIV) type 1-infected patients assigned indinavir/ritonavir (Idv/Rtv; 800/100 mg 2 times daily) or saquinavir/ritonavir (Sqv/Rtv; 1000/100 mg 2 times daily) in an open-label, randomized (1:1), multicenter, phase 4 design. Three hundred six patients began the assigned treatment. At 48 weeks, virological failure was seen in 43 (27%) of 158 and 37 (25%) of 148 patients in the Idv/Rtv and Sqv/Rtv arms, respectively. The time to virological failure did not differ between study arms (P=.76). When switching from randomized treatment was counted as failure, this was seen in 78 of 158 patients in the Idv/Rtv arm, versus 51 of 148 patients in the Sqv/Rtv arm (P=.009). A switch from the randomized treatment occurred in 64 (41%) of 158 patients in the Idv/Rtv arm, versus 40 (27%) of 148 patients in the Sqv/Rtv arm (P=.013). Sixty-four percent of the switches occurred because of adverse events. A greater number of treatment-limiting adverse events were observed in the Idv/Rtv arm, relative to the Sqv/Rtv arm. In conclusion, Rtv-boosed Sqv and Idv were found to have comparable antiretroviral effects in the doses studied.
authors.affiliation: Hvidovre University Hospital, Hvidovre, Denmark. ubd@cphiv.dk
authors.forename: Ulrik Bak
authors.initials: UB
authors.lastname: Dragsted
authors.forename: Jan
authors.initials: J
authors.lastname: Gerstoft
authors.forename: Court
authors.initials: C
authors.lastname: Pedersen
authors.forename: Barry
authors.initials: B
authors.lastname: Peters
authors.forename: Adriana
authors.initials: A
authors.lastname: Duran
authors.forename: Niels
authors.initials: N
authors.lastname: Obel
authors.forename: Antonella
authors.initials: A
authors.lastname: Castagna
authors.forename: Pedro
authors.initials: P
authors.lastname: Cahn
authors.forename: Nathan
authors.initials: N
authors.lastname: Clumeck
authors.forename: Johan N
authors.initials: JN
authors.lastname: Bruun
authors.forename: Jorge
authors.initials: J
authors.lastname: Benetucci
authors.forename: Andrew
authors.initials: A
authors.lastname: Hill
authors.forename: Isabel
authors.initials: I
authors.lastname: Cassetti
authors.forename: Pietro
authors.initials: P
authors.lastname: Vernazza
authors.forename: Mike
authors.initials: M
authors.lastname: Youle
authors.forename: Zoe
authors.initials: Z
authors.lastname: Fox
authors.forename: Jens D
authors.initials: JD
authors.lastname: Lundgren
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology / Q000821:virology; D015497:HIV-1 / Q000187:drug effects / Q000502:physiology; D006801:Humans; D019469:Indinavir / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; 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: D019380:Anti-HIV Agents; D019469:Indinavir; D019258:Saquinavir; D019438:Ritonavir