MULTIPLE DOSE STUDY OF LIPOSOMAL AMIKACIN IN HIV SEROPOTISTIVE PATIENTS

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The goal of this protocol is to define the safety and pharmacokinetics of Mikasome, a liposomal formulation of the aminoglycoside antibiotic amikacin, when given in multiple dose regime. The study is being carried out in HIV-positive volunteers, since this is one of the target populations for the use of this investigational agent which may be efficacious in the treatment of Mycobacterium Avium Complex (MAC). Non- clinical and early human data suggest that the liposomal formulation of amikacin may have substantially different pharmacokinetics, and therefore possible differences in efficacy and toxicity, compared with other formulations. The study design is a parallel group dose escalation study, with each subject receiving a daily infusion of liposomal amikacin for seven consecutive days. Intensive pharmacokinetic sampling is carried out on the first and last infusion days, and for several weeks afterwards. Subjects are monitored closely for signs and symptoms of toxicity, expecially renal toxicity. Pharmacokinetic parameters are analyzed by standard compartmental and non-compartmental methods.