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Journal of Antimicrobial Chemotherapy (2001) 47, 353-355
© 2001 The British Society for Antimicrobial Chemotherapy

Brief report

A phase I/II study of the safety and activity of a microsphere formulation of KNI-272 in patients with HIV-1 infection

D. R. Churchilla, P. M. Sladea, M. Youleb, B. G. Gazzardb and J. N. Webera,*

a Department of Genitourinary Medicine and Communicable Diseases, Imperial College School of Medicine at St Mary's, Norfolk Place, London W2 1PG; b Department of HIV Medicine, Chelsea and Westminster Hospital, 369 Fulham Road, London SW10 9NH, UK

Eighteen patients with symptomatic HIV disease were enrolled into a phase I/II study of a microsphere formulation of the HIV protease inhibitor KNI-272, with doses escalated up to a maximum dose of 60 mg/kg/day. One patient developed reversible elevation in hepatic transaminase. The plasma half-life of the drug was very short, varying between 0.25 and 1.1 h. No consistent effect on plasma HIV RNA levels or CD4+ lymphocyte counts was seen.

* Corresponding author. Tel: +44-20-7886-1539; Fax: +44-20-7886-6645.


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