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

Primary Purpose

Vulvovaginal Candidiases, Yeast Infection, Vulvovaginitis

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Oral Encochleated Amphotericin B (CAMB)
Oral Encochleated Amphotericin B (CAMB)
Sponsored by
Matinas BioPharma Nanotechnologies, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vulvovaginal Candidiases focused on measuring fluconazole, fluconazole-resistant

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Tolan Park Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

CAMB 200 mg

CAMB 400 mg

Arm Description

200 mg CAMB Oral Amphotericin B

400 mg CAMB Oral Amphotericin B

Outcomes

Primary Outcome Measures

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
The proportion of subjects with mycological eradication at the Test of Cure visit
Negative culture for growth of baseline Candida

Secondary Outcome Measures

Incidence of treatment emergent adverse events
Safety assessments include laboratory assessments, vital signs and physical exam

Full Information

First Posted
May 23, 2017
Last Updated
March 6, 2019
Sponsor
Matinas BioPharma Nanotechnologies, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03167957
Brief Title
Efficacy and Safety of Oral Encochleated Amphotericin B (CAMB) in the Treatment of Fluconazole-Resistant Vulvovaginal Candidiasis
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Withdrawn
Why Stopped
No longer target indication
Study Start Date
December 2019 (Anticipated)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Matinas BioPharma Nanotechnologies, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvovaginal Candidiases, Yeast Infection, Vulvovaginitis, Yeast Infection Vaginal, Candidiasis, Vulvovaginal
Keywords
fluconazole, fluconazole-resistant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Parallel assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CAMB 200 mg
Arm Type
Experimental
Arm Description
200 mg CAMB Oral Amphotericin B
Arm Title
CAMB 400 mg
Arm Type
Experimental
Arm Description
400 mg CAMB Oral Amphotericin B
Intervention Type
Drug
Intervention Name(s)
Oral Encochleated Amphotericin B (CAMB)
Other Intervention Name(s)
MAT2203
Intervention Description
Lipid-crystal nano-particle formulation amphotericin B
Intervention Type
Drug
Intervention Name(s)
Oral Encochleated Amphotericin B (CAMB)
Other Intervention Name(s)
MAT2203
Intervention Description
Lipid-crystal nano-particle formulation amphotericin B
Primary Outcome Measure Information:
Title
The proportion of subjects with clinical cure at the Test of Cure visit
Description
Resolution of the VVC signs and symptoms that were present at baseline without further antifungal treatment
Time Frame
28 days
Title
The proportion of subjects with mycological eradication at the Test of Cure visit
Description
Negative culture for growth of baseline Candida
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Incidence of treatment emergent adverse events
Description
Safety assessments include laboratory assessments, vital signs and physical exam
Time Frame
28 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Tolan Park Clinic
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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