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

NCT03167957 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: MB-70008
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Vulvovaginal Candidiases; Yeast Infection; Vulvovaginitis; Yeast Infection Vaginal; Candidiasis, Vulvovaginal

Keywords

fluconazole; fluconazole-resistant

Outcome Measures

Primary Outcomes (2)

• 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

• The proportion of subjects with mycological eradication at the Test of Cure visit

  Negative culture for growth of baseline Candida

  28 days

Secondary Outcomes (1)

• Incidence of treatment emergent adverse events

  28 days

Study Arms (2)

CAMB 200 mg

EXPERIMENTAL

200 mg CAMB Oral Amphotericin B

Drug: Oral Encochleated Amphotericin B (CAMB)

CAMB 400 mg

EXPERIMENTAL

400 mg CAMB Oral Amphotericin B

Drug: Oral Encochleated Amphotericin B (CAMB)

Interventions

Oral Encochleated Amphotericin B (CAMB) DRUG

Lipid-crystal nano-particle formulation amphotericin B

Also known as: MAT2203

CAMB 200 mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Matinas BioPharma Nanotechnologies, Inc.: lead

Study Sites (1)

Tolan Park Clinic

Detroit, Michigan, 48201, United States

Location

MeSH Terms

Conditions

Vulvovaginitis; Candidiasis, Vulvovaginal

Condition Hierarchy (Ancestors)

Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vulvitis; Vulvar Diseases; Genital Diseases; Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel assignment

Study Record Dates

• First Submitted: May 23, 2017
• First Posted: May 30, 2017
• Study Start: December 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: March 8, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)