ACTG 365 PHARMACOKINETIC INTERACTION OF INDINAVIR & RIFABUTIN

ACTG 365-将评估1000 mg q8h吲地那韦方案对利福布汀药代动力学的影响，以及每天150 mg利福布汀对吲哚那韦药代动力学的影响。本研究设计为两个序贯治疗研究臂(臂A和臂B)。ARM A的目的是评估吲地那韦对利福布汀的影响，以及在HIV血清阴性的受试者中交错给药的效果。这需要三个治疗期，其中两个将被跨越。ARM B的目的是评估利福布汀对HIV血清阳性患者吲哚那韦药代动力学的影响。这一臂只需要两个连续的周期，因为利福布汀对吲哚那韦药代动力学的影响应该与药物是同时给药还是交错给药无关。B组服用吲地那韦的最后一周是为了弥补利福布汀的P450诱导效应在停药后持续约7天的事实。

ACTG 365 - The effect of 1000 mg q8h indinavir regimen on rifabutin pharmacokinetics will be evaluated as well as the effect of rifabutin 150 mg daily on indinavir pharmacokinetics. This study is designed with two sequential treatment study arms (Arm A and Arm B). The objective of arm A is to evaluate the effect of indinavir on rifabutin and the effect of rifabutin staggered administration in HIV-seronegative subjects. This requires three treatment periods, two of which will be crossed over. The objective of Arm B is to evaluate the effect of rifabutin on indinavir pharmacokinetics in HIV-seropositive subjects. This arm will require only two sequential periods, since the effect of rifabutin on indinavir pharmacokinetics should be independent of whether the drugs are administered simultaneously or in staggered form. The final week of indinavir dosing in Arm B is to compensate for the fact that rifabutin's P450 induction effects persist for approximately 7 days after the drug is discontinued.