Clinical trial NCT03167957: Efficacy and Safety of Oral Encochleated Amphotericin B (CAMB) in the Treatment of Fluconazole-Resistant Vulvovaginal Candidiasis
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Vulvovaginal Candidiases
Yeast Infection
Vulvovaginitis
Yeast Infection Vaginal
Candidiasis, Vulvovaginal
Keywords: fluconazole
fluconazole-resistant
Lead sponsor: Matinas BioPharma Nanotechnologies, Inc.
Sponsor class: INDUSTRY
First posted: 2017-05-30
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel assignment
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: The proportion of subjects with clinical cure at the Test of Cure visit
timeFrame: 28 days
measure: The proportion of subjects with mycological eradication at the Test of Cure visit
timeFrame: 28 days
Secondary outcomes:
measure: Incidence of treatment emergent adverse events
timeFrame: 28 days
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Tolan Park Clinic
state: Michigan
Study officials:
References: