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

NCT ID: NCT03167957

Last Updated: 2019-03-08

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-31
• Study Completion Date: 2020-12-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CAMB 200 mg

200 mg CAMB Oral Amphotericin B

Group Type: EXPERIMENTAL

Oral Encochleated Amphotericin B (CAMB)

Intervention Type: DRUG

Lipid-crystal nano-particle formulation amphotericin B

CAMB 400 mg

400 mg CAMB Oral Amphotericin B

Group Type: EXPERIMENTAL

Oral Encochleated Amphotericin B (CAMB)

Intervention Type: DRUG

Lipid-crystal nano-particle formulation amphotericin B

Interventions

Oral Encochleated Amphotericin B (CAMB)

Lipid-crystal nano-particle formulation amphotericin B

Intervention Type: DRUG

Oral Encochleated Amphotericin B (CAMB)

Lipid-crystal nano-particle formulation amphotericin B

Intervention Type: DRUG

Other Intervention Names

MAT2203; MAT2203

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Matinas BioPharma Nanotechnologies, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tolan Park Clinic

Detroit, Michigan, United States

Countries

United States

Other Identifiers

MB-70008

Identifier Type: -

Identifier Source: org_study_id