TOLERABILITY &PHARMACOKINETICS OF FORTOVASE

$29,514M01FY2000RRNIH

University Of Alabama At Birmingham, Birmingham AL

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Abstract

Healthy volunteers were randomized into groups receiving different dose combinations of the antiretroviral protease inhibitor agents soft gel cap saquinavir (Saquinavir [unreadable] SGC) and ritonavir versus saquinavir-SGC alone. Combinations were generally well tolerated and safe. Addition of mini-dose ritonavir (100 mg/d) to once daily saquinavir [unreadable] SGC exposure 7 fold and maintained through levels 40-fold higher than the IC90 for HIV. Once daily Didanosire did not alter pharmacokinetics. The study was stopped prematurely because there was not a trend to suggest additional benefit from higher dosages.

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