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

• Status: Withdrawn
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Matinas BioPharma Nanotechnologies, Inc.
• Treatments: Amphotericin B; Liposomal amphotericin B

Criteria

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