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

Phase 2

Completed

Conditions: Vulvovaginitis
Yeast Infection
Yeast Infection Vaginal
Candidiasis, Vulvovaginal

Interventions: Drug: Oral Encochleated Amphotericin B (CAMB)
Drug: Fluconazole

Registration Number: NCT02971007

Lead Sponsor: Matinas BioPharma Nanotechnologies, Inc.

Brief 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 137

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CAMB 200 mg	Oral Encochleated Amphotericin B (CAMB)	200 mg CAMB (MAT2203) Oral Amphotericin B
CAMB 400 mg	Oral Encochleated Amphotericin B (CAMB)	400 mg CAMB (MAT2203) Oral Amphotericin B
Fluconazole 150 mg	Fluconazole	Fluconazole Diflucan

Primary Outcome Measures

Name	Time	Method
Clinical Outcome Assessed at Test of Cure Visit	12 days	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)

Secondary Outcome Measures

Name	Time	Method
Mycological Outcome Assessed at Test of Cure	12 days	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)
Overall Response	12 Days	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).
Change in Composite Clinical Cure Score	Between randomization visit (Baseline) and Day 12 visit (Test of Cure)	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.

Trial Locations

Locations (23): Lawrence OB/GYN
🇺🇸
Lawrenceville, New Jersey, United States
Advanced Research Institute Inc
🇺🇸
New Port Richey, Florida, United States
PMG Research of Wilmington, LLC
🇺🇸
Wilmington, North Carolina, United States
Jackson Clinic
🇺🇸
Jackson, Tennessee, United States
Altus Research
🇺🇸
Lake Worth, Florida, United States
Healthcare Clinical Data, Inc.
🇺🇸
North Miami, Florida, United States
PMG Research of Salisbury, LLC.
🇺🇸
Salisbury, North Carolina, United States
ProHEALTH Care Associates, LLC - Suffolk OB-GYN
🇺🇸
Port Jefferson, New York, United States
Visions Clinical Research
🇺🇸
Wellington, Florida, United States
Medpharmics
🇺🇸
Metairie, Louisiana, United States
Tidewater Clinical Research, Inc.
🇺🇸
Norfolk, Virginia, United States
Precision Trials, LLC
🇺🇸
Phoenix, Arizona, United States
South Florida Medical Research
🇺🇸
Aventura, Florida, United States
Neostart Corporation dba AGA Clinical Trials
🇺🇸
Hialeah, Florida, United States
Clinical Research of West Florida - Tampa
🇺🇸
Tampa, Florida, United States
Mt. Vernon Clinical Research - Wake Research
🇺🇸
Atlanta, Georgia, United States
Brighton Clinical Research Associates
🇺🇸
Norcross, Georgia, United States
Complete Health Care for Women
🇺🇸
Columbus, Ohio, United States
Alabama Clinical Therapeutics
🇺🇸
Birmingham, Alabama, United States
National Research Institute - Wilshire
🇺🇸
Los Angeles, California, United States
Study Center
🇺🇸
Columbus, Ohio, United States
New England Center for Clinical Research, Inc.
🇺🇸
Fall River, Massachusetts, United States
Clinical Trials of Texas, Inc.
🇺🇸
San Antonio, Texas, United States