Browsing by Author "Benetucci, Jorge"
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Item Comparative studies of two-times-daily versus three-times-daily indinavir in combination with zidovudine and lamivudine(2000-09) Haas, David; Arathoon, Eduardo; Thompson, Melanie; de Jesus Pedro, Rogiero; Gallant, Joel E; Uip, David E; Currier, Judith; Noriega, Miguel; Lewi, David; Uribe, Patricia; Benetucci, Jorge; Cahn, Pedro; Paar, David; White, Clinton Jr; Collier, Ann; Ramirez-Ronda, Carlos; Harvey, Charlotte; Chung, Mi-ok; Mehrotra, Devan; Chodakewitz, Jeffrey; Nguyen, Bach-YenObjectives: To compare the efficacy and safety of two-times-daily versus three-times-daily indinavir in combination with zidovudine and lamivudine. Design: Two multicenter, open-label, randomized 24-week studies. Methods: Adults HIV-1 infection, HIV-1 RNA greater than 10000 copies/ml, and no prior lamivudine or protease inhibitor therapy were eligible. In a pilot study (Study A), patients received indinavir at 800 mg every 8 h, 1000 mg every 12 h, or 1200 mg every 12 h. In a subsequent study (Study B), patients received indinavir at 800 mg every 8 h or 1200 mg every 12 h. All subjects received zidovudine (300 mg) and lamivudine (150 mg) every 12 h. An intent-to-treat analysis was used. Results: In Study A, which enrolled 88 patients, neither HIV-1 RNA nor CD4 cell responses differed significantly between treatment groups at 24 weeks when corrected for multiple comparisons. Study B enrolled 433 patients, but was prematurely discontinued when interim analysis suggested greater efficacy of three-times-daily indinavir. Of the first 87 patients reaching week 24, HIV-1 RNA was less than 400 copies/ml in 91% receiving three-times-daily versus 64% receiving two-times-daily indinavir (P < 0.01). Conclusion: Three-times-daily indinavir appears more efficacious than two-times-daily dosing when administered with zidovudine and lamivudine. Two-times-daily indinavir dosing should only be considered in situations characterized by favorable pharmacokinetic drug-drug interactions.Item Correction: HLA-Driven Convergence of HIV-1 Viral Subtypes B and F Toward the Adaptation to Immune Responses in Human Populations(2008-11-04) Dilernia, Dario; Jones, Leandro; Rodriguez, Sabrina; Turk, Gabriela; Rubio, Andrea E; Pampuro, Sandra; Gomez-Carrillo, Manuel; Bautista, Christian T; Deluchi, Gabriel; Benetucci, Jorge; Lasala, María Beatriz; Lourtau, Leonardo; Losso, Marcelo Horacio; Perez, Héctor; Cahn, Pedro; Salomon, HoracioThe eighth author's name was displayed incorrectly. It should be: Christian T. Bautista.Item HLA-Driven Convergence of HIV-1 Viral Subtypes B and F Toward the Adaptation to Immune Responses in Human Populations(2008-10-21) Dilernia, Dario; Jones, Leandro; Rodriguez, Sabrina; Turk, Gabriela; Rubio, Andrea E; Pampuro, Sandra; Gomez-Carrillo, Manuel; Bautista, Christian; Deluchi, Gabriel; Benetucci, Jorge; Lasala, María Beatriz; Lourtau, Leonardo; Losso, Marcelo Horacio; Perez, Héctor; Cahn, Pedro; Salomon, HoracioFil: Cahn P. Fundación Huésped, Buenos Aires; ArgentinaItem Randomized Trial to Evaluate Indinavir/Ritonavir versus Saquinavir/Ritonavir in Human Immunodeficiency Virus Type 1–Infected Patients: The MaxCmin1 Trial(2003-09-01) Dragsted, Ulrik Bak; Gerstoft, Jan; Pedersen, Court; Peters, Barry; Duran, Adriana; Obel, Niels; Castagna, Antonella; Cahn, Pedro; Clumeck, Nathan; Bruun, Johan N; Benetucci, Jorge; Hill, Andrew; Cassetti, Isabel; Vernazza, Pietro; Youle, Mike; Fox, Zoe; MaxCmin1 Trial GroupThis 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