Phase III (BA 2004/01/04) Pivotal Study, Oropharyngeal
Candidiasis in HIV positive patients (ongoing)
A noninferiority trial conducted in HIV-positive patients with
oropharyngeal candidiasis at clinical sites in the U.S, Canada
and South Africa (540 patients expected). This is a double blind,
double dummy, randomized, and controlled trial. The primary
objective is to evaluate the clinical efficacy of the 50 mg
Loramyc® (miconazole Lauriad®) mucoadhesive buccal tablet
(1x per day) for oropharyngeal candidiasis, after 14 days of
consecutive treatment, in comparison with Mycelex® Troches
(5 x per day).
