ACTG 365 PHARMACOKINETIC INTERACTION OF INDINAVIR & RIFABUTIN

ACTG 365 -将评价1000 mg q8 h茚地那韦方案对利福布雷迪药代动力学的影响，以及利福布雷迪每日150 mg对茚地那韦药代动力学的影响。 本研究设计了两个序贯治疗研究组（A组和B组）。 A组的目的是在HIV血清阴性受试者中评价茚地那韦对利法布里的影响以及利法布里交错给药的影响。 这需要三个治疗阶段，其中两个将交叉。 B组的目的是在HIV血清阳性受试者中评价利法布雷迪对茚地那韦药代动力学的影响。 这一组只需要两个连续的阶段，因为利法布雷迪对茚地那韦药代动力学的影响应该是独立的药物是同时给药还是交错给药。 在B组中茚地那韦给药的最后一周是为了补偿在停药后利法布汀的P450诱导作用持续约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.