Candidiasis, Vulvovaginal, Vulvovaginal Candidiases, Vulvovaginitis, Yeast Infection, Yeast Infection Vaginal
Conditions
Keywords
fluconazole, fluconazole-resistant
Brief summary
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).
Detailed description
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.
Interventions
Lipid-crystal nano-particle formulation amphotericin B
Sponsors
Matinas BioPharma Nanotechnologies, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Parallel assignment
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Female 18-65 years * Informed Consent * Clinical diagnosis of fluconazole-resistant VVC * Negative pregnancy test * Vaginal pH ≤ 4.5
Exclusion criteria
* Intolerance or hypersensitivity to any amphotericin B (AMB) product or to azole antifungal drugs * Receiving antifungal therapy unrelated to VVC or has evidence of systemic fungal infections requiring antifungal therapy * Received antifungal treatment for VVC within past 10 days except fluconazole, subjects must discontinue fluconazole after informed consent * Has another cause or suspected cause of vulvovaginitis * Has active HPV * Has other urogenital infection * Has other vaginal or vulvar condition that would confound interpretation of clinical response * Has significant laboratory abnormality at screening * Has Type I diabetes, use of insulin, HbA1c\>10 * Exposure to any investigational product within 30 days of screening * Has other condition that would interfere with subject ability to provide informed consent or put subject at undue risk
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of subjects with clinical cure at the Test of Cure visit | 28 days | Resolution of the VVC signs and symptoms that were present at baseline without further antifungal treatment |
| The proportion of subjects with mycological eradication at the Test of Cure visit | 28 days | Negative culture for growth of baseline Candida |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of treatment emergent adverse events | 28 days | Safety assessments include laboratory assessments, vital signs and physical exam |
Countries
United States
Outcome results
None listed