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Type: Artigo de periódico
Title: Comparative studies of two-times-daily versus three-times-daily indinavir in combination with zidovudine and lamivudine
Author: Haas, DW
Arathoon, E
Thompson, MA
Pedro, RD
Gallant, JE
Uip, DE
Currier, J
Noriega, LM
Lewi, DS
Uribe, P
Benetucci, J
Cahn, P
Paar, D
White, CA
Collier, AC
Ramirez-Ronda, CH
Harvey, C
Chung, M
Mehrotra, D
Chodakewitz, J
Nguyen, BY
Abstract: Objectives: 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 10 000 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-limes-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. (C) 2000 Lippincott Williams & Wilkins.
Subject: antiretroviral therapy
clinical trial
HIV infection
viral load
HIV protease inhibitors
Country: EUA
Editor: Lippincott Williams & Wilkins
Rights: fechado
Identifier DOI: 10.1097/00002030-200009080-00013
Date Issue: 2000
Appears in Collections:Unicamp - Artigos e Outros Documentos

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