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

Sponsor
Matinas BioPharma Nanotechnologies, Inc. (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT03167957
Collaborator
(none)
0
Enrollment
1
Location
2
Arms
12
Anticipated Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Drug: Oral Encochleated Amphotericin B (CAMB)
  • Drug: Oral Encochleated Amphotericin B (CAMB)
 Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Parallel assignmentParallel assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Dec 1, 2019
Anticipated Primary Completion Date :
Dec 1, 2020
Anticipated Study Completion Date :
Dec 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: CAMB 200 mg

200 mg CAMB Oral Amphotericin B

Drug: Oral Encochleated Amphotericin B (CAMB)
Lipid-crystal nano-particle formulation amphotericin B
Other Names:
  • MAT2203

    		•
    Experimental: CAMB 400 mg

    400 mg CAMB Oral Amphotericin B

    Drug: Oral Encochleated Amphotericin B (CAMB)
    Lipid-crystal nano-particle formulation amphotericin B
    Other Names:
  • MAT2203

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    2. 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

    1. Incidence of treatment emergent adverse events [28 days]

      Safety assessments include laboratory assessments, vital signs and physical exam

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tolan Park Clinic Detroit Michigan United States 48201

    Sponsors and Collaborators

    • Matinas BioPharma Nanotechnologies, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Matinas BioPharma Nanotechnologies, Inc.
    ClinicalTrials.gov Identifier:
    NCT03167957
    Other Study ID Numbers:
    • MB-70008
    First Posted:
    May 30, 2017
    Last Update Posted:
    Mar 8, 2019
    Last Verified:
    Mar 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Matinas BioPharma Nanotechnologies, Inc.
    fluconazole
    fluconazole-resistant
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases
    Candidiasis
    Candidiasis, Vulvovaginal
    Mycoses
    Vulvovaginitis
    Amphotericin B
    Liposomal amphotericin B

    Study Results

    No Results Posted as of Mar 8, 2019