Clinical trial NCT02971007: Safety and Efficacy of Oral Encochleated Amphotericin B (CAMB/MAT2203) in the Treatment of Vulvovaginal Candidiasis (VVC)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Vulvovaginitis
Yeast Infection
Yeast Infection Vaginal
Candidiasis, Vulvovaginal
Lead sponsor: Matinas BioPharma Nanotechnologies, Inc.
Sponsor class: INDUSTRY
First posted: 2016-11-22
Enrollment: 137
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical Outcome Assessed at Test of Cure Visit
timeFrame: 12 days
Secondary outcomes:
measure: Mycological Outcome Assessed at Test of Cure
timeFrame: 12 days
measure: Overall Response
timeFrame: 12 Days
measure: Change in Composite Clinical Cure Score
timeFrame: Between randomization visit (Baseline) and Day 12 visit (Test of Cure)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics
state: Alabama
city: Phoenix
country: United States
facility: Precision Trials, LLC
state: Arizona
city: Los Angeles
country: United States
facility: National Research Institute - Wilshire
state: California
city: Aventura
country: United States
facility: South Florida Medical Research
state: Florida
city: Hialeah
country: United States
facility: Neostart Corporation dba AGA Clinical Trials
state: Florida
city: Lake Worth
country: United States
facility: Altus Research
state: Florida
city: New Port Richey
country: United States
facility: Advanced Research Institute Inc
state: Florida
city: North Miami
country: United States
facility: Healthcare Clinical Data, Inc.
state: Florida
city: Tampa
country: United States
facility: Clinical Research of West Florida - Tampa
state: Florida
city: Wellington
country: United States
facility: Visions Clinical Research
state: Florida
city: Atlanta
country: United States
facility: Mt. Vernon Clinical Research - Wake Research
state: Georgia
city: Norcross
country: United States
facility: Brighton Clinical Research Associates
state: Georgia
city: Metairie
country: United States
facility: Medpharmics
state: Louisiana
city: Fall River
country: United States
facility: New England Center for Clinical Research, Inc.
state: Massachusetts
city: Lawrenceville
country: United States
facility: Lawrence OB/GYN
state: New Jersey
city: Port Jefferson
country: United States
facility: ProHEALTH Care Associates, LLC - Suffolk OB-GYN
state: New York
city: Salisbury
country: United States
facility: PMG Research of Salisbury, LLC.
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington, LLC
state: North Carolina
city: Columbus
country: United States
facility: Complete Health Care for Women
state: Ohio
city: Columbus
country: United States
facility: Study Center
state: Ohio
city: Jackson
country: United States
facility: Jackson Clinic
state: Tennessee
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc.
state: Texas
city: Norfolk
country: United States
facility: Tidewater Clinical Research, Inc.
state: Virginia
Study officials:
affiliation: Matinas BioPharma Nanotechnologies, Inc.
name: Douglas Kling
role: STUDY_DIRECTOR
References: