PLACEBO CONTROLLED STUDY OF SAFETY OF PMPA IN HIV+ PATIENTS

$0M01FY2000RRNIH

Johns Hopkins University, Baltimore MD

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Abstract

All subject evaluations have been completed. In this study, PMPA prodrug demonstrated dose-related anti-HIV effect at the end of 28 days of dosing; median log10 decreases in HIV RNA from baseline were 0.32, 0.44, and 1.22. Pharmacokinetic data obtained in this study showed that exposure was dose related and that the serum half life was > 17 hours. Data obtained from this study are being used to choose doses and dosing regimens for the Phase II larger trials that are being designed at the current time

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