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

Withdrawn before enrolling · Phase 2

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

In brief

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).

Key facts

Study ID: NCT03167957
Run by: Matinas BioPharma Nanotechnologies, Inc.
People needed: 0
Starts: 2019-12-01
Expected to finish: 2020-12-01
Last updated by the study team: 2019-03-08

Who can join

Age: 18 and older, up to 65. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

Female 18-65 years
Informed Consent
Clinical diagnosis of fluconazole-resistant VVC
Negative pregnancy test
Vaginal pH ≤ 4.5

You may not qualify if…

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

Where it is running

Tolan Park Clinic — Detroit, Michigan, United States

Full record on ClinicalTrials.gov

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