This is a single-center, open-label, pilot study to evaluate the efficacy of 14 days of CAMB dosing in subjects with fluconazole-resistant vulvovaginal candidiasis (VVC).
This is a single-center, open-label, pilot study to evaluate the efficacy of 14 days of CAMB dosing in subjects with fluconazole-resistant vulvovaginal candidiasis (VVC). Approximately 16 women with fluconazole-resistant VVC will be randomized to either 200 mg or 400 mg oral CAMB for 14 days. The primary objectives of this study are to assess the clinical cure rate, mycology eradication and responder outcome. The secondary objective of this study is to evaluate the safety of 200 mg and 400 mg doses of oral CAMB.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Lipid-crystal nano-particle formulation amphotericin B
Lipid-crystal nano-particle formulation amphotericin B
Tolan Park Clinic
Detroit, Michigan, United States
The proportion of subjects with clinical cure at the Test of Cure visit
Resolution of the VVC signs and symptoms that were present at baseline without further antifungal treatment
Time frame: 28 days
The proportion of subjects with mycological eradication at the Test of Cure visit
Negative culture for growth of baseline Candida
Time frame: 28 days
Incidence of treatment emergent adverse events
Safety assessments include laboratory assessments, vital signs and physical exam
Time frame: 28 days
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