title: The SPICE study: 48-week activity of combinations of saquinavir soft gelatin and nelfinavir with and without nucleoside analogues. Study of Protease Inhibitor Combinations in Europe.
abstract: OBJECTIVE
  To compare the efficacy and safety of saquinavir soft gelatin capsules (SQV-SGC) and nelfinavir (NFV), with or without two concomitant nucleoside reverse transcriptase inhibitors (NRTIs), in an exploratory objective to identify populations most likely to benefit from quadruple therapy.
  
  
  METHODS
  Phase II/III, open-label, randomized, parallel-arm, multicenter trial.
  
  
  METHODS
  Enrollment included 157 protease inhibitor-naive adults (> or = 13 years) with HIV-1 RNA > or = 10,000 copies/ml; 132 participants completed 48 weeks of therapy.
  
  
  METHODS
  SQV-SGC 1200 mg, NFV 750 mg, SQV-SGC 800 mg plus NFV 750 mg, all with two NRTIs, and SQV-SGC 800 mg plus NFV 750 mg alone, all three times daily for 48 weeks.
  
  
  METHODS
  Proportion of participants with HIV-1 RNA <50 copies/ ml (16 and 48 weeks); time to virologic relapse (48 weeks).
  
  
  RESULTS
  Proportions of patients with HIV RNA <50 copies/ml were not statistically significantly different between arms at 16 or 48 weeks, although trends favored the quadruple-therapy arm. In patients experiencing virologic relapse, time to relapse was statistically significantly longer in the quadruple-therapy arm than in the other three arms (p = .007). Quadruple therapy provided benefit in NRTI-experienced patients and those with viral loads above the median value at baseline. Adverse events were mainly mild gastrointestinal disorders in all treatment arms.
  
  
  CONCLUSIONS
  Quadruple therapy, including SQV-SGC and NFV, gave a more durable response than triple therapy with either single protease inhibitor. Quadruple therapy might particularly benefit NRTI-experienced patients and those with high baseline viral loads.
authors.affiliation: The Kobler Clinic, Chelsea and Westminster Hospital, London, UK.
authors.forename: G
authors.initials: G
authors.lastname: Moyle
authors.forename: A
authors.initials: A
authors.lastname: Pozniak
authors.forename: M
authors.initials: M
authors.lastname: Opravil
authors.forename: N
authors.initials: N
authors.lastname: Clumeck
authors.forename: J F
authors.initials: JF
authors.lastname: DelFraissy
authors.forename: M
authors.initials: M
authors.lastname: Johnson
authors.forename: J
authors.initials: J
authors.lastname: Pelgrom
authors.forename: J
authors.initials: J
authors.lastname: Reynes
authors.forename: D
authors.initials: D
authors.lastname: Vittecoq
authors.forename: P
authors.initials: P
authors.lastname: DeLora
authors.forename: M
authors.initials: M
authors.lastname: Salgo
authors.forename: F
authors.initials: F
authors.lastname: Duff
mesh_terms: D000328:Adult; D018791:CD4 Lymphocyte Count; D015331:Cohort Studies; D004359:Drug Therapy, Combination; D005060:Europe; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D017320:HIV Protease Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use*; D015497:HIV-1; D006801:Humans; D008297:Male; D019888:Nelfinavir / Q000008:administration & dosage / Q000627:therapeutic use*; D011247:Pregnancy; D012367:RNA, Viral / Q000032:analysis; D019258:Saquinavir / Q000008:administration & dosage / Q000627:therapeutic use*
chemical_list: D017320:HIV Protease Inhibitors; D012367:RNA, Viral; D019888:Nelfinavir; D019258:Saquinavir