Comparative studies of two-times-daily versus three-times-daily indinavir in combination with zidovudine and lamivudine
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2000-09-08
Autores
Haas, D. W.
Arathoon, E.
Thompson, M. A.
Pedro, R. D.
Gallant, J. E.
Uip, D. E.
Currier, J.
Noriega, L. M.
Lewi, David S. [UNIFESP]
Uribe, P.
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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.
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Aids. Philadelphia: Lippincott Williams & Wilkins, v. 14, n. 13, p. 1973-1978, 2000.