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Randomized Trial to Evaluate Indinavir/Ritonavir versus Saquinavir/Ritonavir in Human Immunodeficiency Virus Type 1-Infected Patients: The MaxCminl Trial

Ulrik Bak Dragsted, Jan Gerstoft, Court Pedersen, Barry Peters, Adriana Duran, Niels Obel, Antonella Castagna, Pedro Cahn, Nathan Clumeck, Johan N. Bruun, Jorge Benetucci, Andrew Hill, Isabel Cassetti, Pietro Vernazza, Mike Youle, Zoe Fox, Jens D. Lundgren and MaxCmin1 Trial Group
The Journal of Infectious Diseases
Vol. 188, No. 5 (Sep. 1, 2003), pp. 635-642
Published by: Oxford University Press
Stable URL: http://www.jstor.org/stable/30075693
Page Count: 8
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Randomized Trial to Evaluate Indinavir/Ritonavir versus Saquinavir/Ritonavir in Human Immunodeficiency Virus Type 1-Infected Patients: The MaxCminl Trial
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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.

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