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Belloso, W; Ivalo, S; Benetucci, J; Pugliese, D; Garone, D; Cahn, P; Krolewiecki, A; Casiro, A; Cassetti, I; Bologna, R; Duran, A; Toibaro, J; Rieger, A; Vago, B; Clumeck, N; Kabeya, K; Cooper, C; Dufresne, S; Lalonde, R; Walmsley, S; Gerstoft, J; Mathiesen, L; Nielsen, H; Obel, N; [...]

A Randomized Trial to Evaluate Lopinavir/Ritonavir versus Saquinavir/Ritonavir in HIV-1-Infected Patients: The Maxcmin2 Trial

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  • Media type: E-Article
  • Title: A Randomized Trial to Evaluate Lopinavir/Ritonavir versus Saquinavir/Ritonavir in HIV-1-Infected Patients: The Maxcmin2 Trial
  • Contributor: Belloso, W; Ivalo, S; Benetucci, J; Pugliese, D; Garone, D; Cahn, P; Krolewiecki, A; Casiro, A; Cassetti, I; Bologna, R; Duran, A; Toibaro, J; Rieger, A; Vago, B; Clumeck, N; Kabeya, K; Cooper, C; Dufresne, S; Lalonde, R; Walmsley, S; Gerstoft, J; Mathiesen, L; Nielsen, H; Obel, N; [...]
  • Published: SAGE Publications, 2005
  • Published in: Antiviral Therapy, 10 (2005) 6, Seite 735-743
  • Language: English
  • DOI: 10.1177/135965350501000608
  • ISSN: 1359-6535; 2040-2058
  • Origination:
  • Footnote:
  • Description: <jats:sec><jats:title>Objective</jats:title><jats:p>To assess the rate of protocol-defined treatment failure and safety of lopinavir/ritonavir (LPV/r) and saquinavir/ritonavir (SAQ/r).</jats:p></jats:sec><jats:sec><jats:title>Design</jats:title><jats:p>Open-label, prospective, randomized (1:1), international multi-centre trial.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>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 (30%) 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).</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>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.</jats:p></jats:sec>
  • Access State: Open Access