Browsing by Author "de Jesus Pedro, Rogiero"

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    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-Yen
    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 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.