Haas, DavidArathoon, EduardoThompson, Melaniede Jesus Pedro, RogieroGallant, Joel EUip, David ECurrier, JudithNoriega, MiguelLewi, DavidUribe, PatriciaBenetucci, JorgeCahn, PedroPaar, DavidWhite, Clinton JrCollier, AnnRamirez-Ronda, CarlosHarvey, CharlotteChung, Mi-okMehrotra, DevanChodakewitz, JeffreyNguyen, Bach-Yen2024-05-232024-05-232000-09https://doi.org/10.1097/00002030-200009080-00013https://journals.lww.com/aidsonline/Fulltext/2000/09080/Comparative_studies_of_two_times_daily_versus.13.aspxhttps://repositorio.huesped.org.ar/handle/123456789/1351Fil: Cahn, P. Fundación Huésped. Ciudad Autónoma de Buenos Aires; Argentina.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.application/pdfopenAccessResultado del TratamientoIndinavirZidovudinaLamivudineArticulo