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

Candidiasis, Vulvovaginal Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03167957
• Other study ID #: MB-70008
• Status: Withdrawn
• Phase: Phase 2
• Start date: December 2019
• Est. completion date: December 2020

Study information

• Verified date: March 2019
• Source: Matinas BioPharma Nanotechnologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Vulvovaginal
• Communicable Diseases
• Infection
• Mycoses
• Vulvovaginal Candidiases
• Vulvovaginitis
• Yeast Infection
• Yeast Infection Vaginal

Intervention

Drug:
• Oral Encochleated Amphotericin B (CAMB)
Lipid-crystal nano-particle formulation amphotericin B
• Oral Encochleated Amphotericin B (CAMB)
Lipid-crystal nano-particle formulation amphotericin B

Locations

Country	Name	City	State
United States	Tolan Park Clinic	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Matinas BioPharma Nanotechnologies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	The proportion of subjects with mycological eradication at the Test of Cure visit	Negative culture for growth of baseline Candida	28 days
Secondary	Incidence of treatment emergent adverse events	Safety assessments include laboratory assessments, vital signs and physical exam	28 days