ACTG 365 PHARMACOKINETIC INTERACTION OF INDINAVIR & RIFABUTIN

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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.