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

Candidiasis, Vulvovaginal Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02971007
• Other study ID #: MB-70005
• Status: Completed
• Phase: Phase 2
• Start date: November 2016
• Est. completion date: May 2017

Study information

• Verified date: October 2018
• Source: Matinas BioPharma Nanotechnologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Vulvovaginal
• Communicable Diseases
• Infection
• Mycoses
• Vulvovaginitis
• Yeast Infection
• Yeast Infection Vaginal

Intervention

Drug:
• Oral Encochleated Amphotericin B (CAMB)
lipid-crystal nano-particle formulation amphotericin B
• Fluconazole

Locations

Country	Name	City	State
United States	Mt. Vernon Clinical Research - Wake Research	Atlanta	Georgia
United States	South Florida Medical Research	Aventura	Florida
United States	Alabama Clinical Therapeutics	Birmingham	Alabama
United States	Complete Health Care for Women	Columbus	Ohio
United States	Study Center	Columbus	Ohio
United States	New England Center for Clinical Research, Inc.	Fall River	Massachusetts
United States	Neostart Corporation dba AGA Clinical Trials	Hialeah	Florida
United States	Jackson Clinic	Jackson	Tennessee
United States	Altus Research	Lake Worth	Florida
United States	Lawrence OB/GYN	Lawrenceville	New Jersey
United States	National Research Institute - Wilshire	Los Angeles	California
United States	Medpharmics	Metairie	Louisiana
United States	Advanced Research Institute Inc	New Port Richey	Florida
United States	Brighton Clinical Research Associates	Norcross	Georgia
United States	Tidewater Clinical Research, Inc.	Norfolk	Virginia
United States	Healthcare Clinical Data, Inc.	North Miami	Florida
United States	Precision Trials, LLC	Phoenix	Arizona
United States	ProHEALTH Care Associates, LLC - Suffolk OB-GYN	Port Jefferson	New York
United States	PMG Research of Salisbury, LLC.	Salisbury	North Carolina
United States	Clinical Trials of Texas, Inc.	San Antonio	Texas
United States	Clinical Research of West Florida - Tampa	Tampa	Florida
United States	Visions Clinical Research	Wellington	Florida
United States	PMG Research of Wilmington, LLC	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Matinas BioPharma Nanotechnologies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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)