Efficacy and Safety of Oral Encochleated Amphotericin B (CAMB) in the Treatment of Fluconazole-Resistant Vulvovaginal Candidiasis

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Single-Center, Open-Label, Pilot Study to Evaluate the Efficacy and Safety of Oral Encochleated Amphotericin B (CAMB) in the Treatment of Fluconazole-Resistant Vulvovaginal Candidiasis

Conditions
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Vulvovaginal Candidiases, Yeast Infection, Vulvovaginitis, Yeast Infection Vaginal, Candidiasis, Vulvovaginal

Intervention / Treatment
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* Drug: Oral Encochleated Amphotericin B (CAMB)
* Drug: Oral Encochleated Amphotericin B (CAMB)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CAMB 200 mg<br>200 mg CAMB Oral Amphotericin B | Drug: Oral Encochleated Amphotericin B (CAMB)<br>* Lipid-crystal nano-particle formulation amphotericin B<br>* Other names: MAT2203;|
| Experimental: CAMB 400 mg<br>400 mg CAMB Oral Amphotericin B | Drug: Oral Encochleated Amphotericin B (CAMB)<br>* Lipid-crystal nano-particle formulation amphotericin B<br>* Other names: MAT2203;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 28 days | 
| The proportion of subjects with mycological eradication at the Test of Cure visit | Negative culture for growth of baseline Candida | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment emergent adverse events | Safety assessments include laboratory assessments, vital signs and physical exam | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fluconazole, fluconazole-resistant