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

Phase 2

Withdrawn

• Conditions: Vulvovaginal Candidiases; Candidiasis, Vulvovaginal; Yeast Infection; Vulvovaginitis; Yeast Infection Vaginal
• Interventions: Drug: Oral Encochleated Amphotericin B (CAMB)

• Registration Number: NCT03167957
• Lead Sponsor: Matinas BioPharma Nanotechnologies, Inc.

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.

Study Timeline

• Study First Submitted: 2017-05-23
• Study First Submitted QC: 2017-05-24
• Study First Posted: 2017-05-30
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-06
• Last Update Posted: 2019-03-08
• Study Start: 2019-12
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CAMB 400 mg	Oral Encochleated Amphotericin B (CAMB)	400 mg CAMB Oral Amphotericin B
CAMB 200 mg	Oral Encochleated Amphotericin B (CAMB)	200 mg CAMB Oral Amphotericin B

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Incidence of treatment emergent adverse events	28 days	Safety assessments include laboratory assessments, vital signs and physical exam

Trial Locations

Locations (1)

Tolan Park Clinic; 🇺🇸 Detroit, Michigan, United States