Safety and Efficacy of Oral Encochleated Amphotericin B (CAMB/MAT2203) in the Treatment of Vulvovaginal Candidiasis (VVC)

A Multi-Center Randomized Study to Evaluate the Safety, Tolerability, and Efficacy of Oral Encochleated Amphotericin B (CAMB/MAT2203) Compared With Oral Fluconazole in the Treatment of Moderate to Severe Vulvovaginal Candidiasis (VVC)

This is a multi-center, randomized study to evaluate the safety, tolerability, and efficacy of 200 mg CAMB and 400 mg CAMB compared with a single 150 mg dose of fluconazole in the treatment of moderate to severe VVC.

Study Overview

• Status: Completed
• Conditions: Vulvovaginitis; Candidiasis, Vulvovaginal; Yeast Infection; Yeast Infection Vaginal
• Intervention / Treatment: Drug: Fluconazole; Drug: Oral Encochleated Amphotericin B (CAMB)

Detailed Description

This is a multi-center, randomized study to evaluate the safety, tolerability, and efficacy of 200 mg CAMB and 400 mg CAMB compared with a single 150 mg dose of fluconazole in the treatment of moderate to severe VVC.

Approximately 75 women with moderate to severe VVC will be randomized to 1 of 3 treatment groups (200 mg CAMB, 400 mg CAMB, or fluconazole) to achieve approximately 25 subjects in each group. The primary objective of this study is to evaluate the safety of 200 mg and 400 mg doses of oral CAMB for 5 days compared with a single 150 mg dose of oral fluconazole in subjects with moderate to severe VVC. The secondary efficacy objectives of this study included the clinical cure rate, mycology eradication and responder outcome. Tertiary objectives include pharmacokinetics.

• Study Type: Interventional
• Enrollment (Actual): 137
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Alabama Clinical Therapeutics
  • Arizona
    • Phoenix, Arizona, United States, 85032
      • Precision Trials, LLC
  • California
    • Los Angeles, California, United States, 90057
      • National Research Institute - Wilshire
  • Florida
    • Aventura, Florida, United States, 33180
      • South Florida Medical Research
    • Hialeah, Florida, United States, 33012
      • Neostart Corporation dba AGA Clinical Trials
    • Lake Worth, Florida, United States, 33461
      • Altus Research
    • New Port Richey, Florida, United States, 34653
      • Advanced Research Institute Inc
    • North Miami, Florida, United States, 33161
      • Healthcare Clinical Data, Inc.
    • Tampa, Florida, United States, 33603
      • Clinical Research of West Florida - Tampa
    • Wellington, Florida, United States, 33414
      • Visions Clinical Research
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • Mt. Vernon Clinical Research - Wake Research
    • Norcross, Georgia, United States, 30092
      • Brighton Clinical Research Associates
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • MedPharmics
  • Massachusetts
    • Fall River, Massachusetts, United States, 02720
      • New England Center for Clinical Research, Inc.
  • New Jersey
    • Lawrenceville, New Jersey, United States, 08648
      • Lawrence OB/GYN
  • New York
    • Port Jefferson, New York, United States, 11777
      • ProHEALTH Care Associates, LLC - Suffolk OB-GYN
  • North Carolina
    • Salisbury, North Carolina, United States, 28144
      • PMG Research of Salisbury, LLC.
    • Wilmington, North Carolina, United States, 28401
      • PMG Research of Wilmington, LLC
  • Ohio
    • Columbus, Ohio, United States, 43231
      • Complete Health Care for Women
    • Columbus, Ohio, United States, 43231
      • Study Center
  • Tennessee
    • Jackson, Tennessee, United States, 38305
      • Jackson Clinic
  • Texas
    • San Antonio, Texas, United States, 78229
      • Clinical Trials of Texas, Inc.
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Tidewater Clinical Research, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Key Inclusion Criteria:

Informed consent

Clinical diagnosis of moderate to severe VVC

Negative pregnancy test

Vaginal pH less than 4.5

Key Exclusion Criteria:

Has an 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

Has received treatment for VVC within the past 30 days or has experienced 4 or more episodes of VVC in the past 12 months

Has another cause of vulvovaginitis

Has other urogenital infection(s) that would potentially alter their response to disease

Has another vaginal or vulvar condition that would confound the interpretation of clinical response

Has significant laboratory abnormality at screening

Has any known azole-resistant Candida infection;

Has any other condition the Investigator believes would interfere with the subject's ability to provide informed consent, comply with study instructions, or puts the subject at undue risk

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CAMB 200 mg; 200 mg CAMB (MAT2203) 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 (MAT2203) Oral Amphotericin B	Drug: Oral Encochleated Amphotericin B (CAMB); lipid-crystal nano-particle formulation amphotericin B; Other Names: MAT2203
Active Comparator: Fluconazole 150 mg; Fluconazole Diflucan	Drug: Fluconazole

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Outcome Assessed at Test of Cure Visit	Number of patients determined to be a Clinical Cure (resolution of the VVC signs and symptoms that were present at baseline without further antifungal treatment); Clinical Failure (incomplete resolution of signs and symptoms of VVC that were present at baseline or new signs and symptoms have developed and require the initiation of non-study antifungal drugs); or Clinical indeterminate (insufficient data are available to determine if the subject is a cure or failure)	12 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mycological Outcome Assessed at Test of Cure	Number of patients with mycological eradication (vaginal swab culture negative for growth of baseline Candida species); mycological persistence (vaginal swab culture positive for growth of baseline Candida species); or mycological indeterminate (vaginal swab culture not available or the culture cannot be interpreted or is considered contaminated)	12 days
Overall Response	Number of patients with overall response at Day 12 (Test of cure visit) of composite signs and symptoms defined as overall success (achievement of both a clinical cure and microbiological eradication); overall failure (clinical failure or microbiological persistence) or overall indeterminate (insufficient data are available to determine if the patient is an overall success or failure).	12 Days
Change in Composite Clinical Cure Score	The percent change from baseline to Day 12 (Test of Cure Visit) of the composite clinical cure score of signs (erythema, edema or excoriation) and symptoms (itching, burning or irritation) on a scale of 0 to 3 for each sign and symptom where 0 = none (complete absence of any sign or symptom); 1 = mild (slight); 2 = moderate (definitely present) or 3 = severe (marked/intense). The maximum score at baseline = 18 (score of 3 for each sign and symptom). The minimum score at baseline = 4 (score of 2 for at least 2 signs or symptoms). A lower score at Day 12 represents a better outcome. The mean percent change from baseline score to Day 12 score is presented for each arm as a negative number and represents a decrease in severity of signs and symptoms. A bigger decrease represents a better outcome.	Between randomization visit (Baseline) and Day 12 visit (Test of Cure)

Collaborators and Investigators

• Sponsor: Matinas BioPharma Nanotechnologies, Inc.
• Investigators: Study Director: Douglas Kling, Matinas BioPharma Nanotechnologies, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: November 10, 2016
• First Submitted That Met QC Criteria: November 18, 2016
• First Posted (Estimate): November 22, 2016

Study Record Updates

• Last Update Posted (Actual): November 2, 2018
• Last Update Submitted That Met QC Criteria: October 4, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Bacterial Infections and Mycoses; Vaginal Diseases; Vulvar Diseases; Vaginitis; Vulvitis; Infections; Communicable Diseases; Candidiasis; Mycoses; Vulvovaginitis; Candidiasis, Vulvovaginal; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; Antiprotozoal Agents; Antiparasitic Agents; Amebicides; 14-alpha Demethylase Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; Cytochrome P-450 CYP2C19 Inhibitors; Fluconazole; Amphotericin B; Liposomal amphotericin B
• Other Study ID Numbers: MB-70005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No