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Trial record 10 of 17 for:    "Vulvovaginal Candidiasis" | "Fluconazole"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03167957
Recruitment Status : Withdrawn (No longer target indication)
First Posted : May 30, 2017
Last Update Posted : March 8, 2019
Sponsor:
Information provided by (Responsible Party):
Matinas BioPharma Nanotechnologies, Inc.

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).

Condition or disease Intervention/treatment Phase
Vulvovaginal Candidiases Yeast Infection Vulvovaginitis Yeast Infection Vaginal Candidiasis, Vulvovaginal Drug: Oral Encochleated Amphotericin B (CAMB) Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : December 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Yeast Infections

Arm Intervention/treatment
Experimental: CAMB 200 mg
200 mg CAMB Oral Amphotericin B
Drug: Oral Encochleated Amphotericin B (CAMB)
Lipid-crystal nano-particle formulation amphotericin B
Other Name: MAT2203

Experimental: CAMB 400 mg
400 mg CAMB Oral Amphotericin B
Drug: Oral Encochleated Amphotericin B (CAMB)
Lipid-crystal nano-particle formulation amphotericin B
Other Name: MAT2203




Primary Outcome Measures :
  1. The proportion of subjects with clinical cure at the Test of Cure visit [ Time Frame: 28 days ]
    Resolution of the VVC signs and symptoms that were present at baseline without further antifungal treatment

  2. The proportion of subjects with mycological eradication at the Test of Cure visit [ Time Frame: 28 days ]
    Negative culture for growth of baseline Candida


Secondary Outcome Measures :
  1. Incidence of treatment emergent adverse events [ Time Frame: 28 days ]
    Safety assessments include laboratory assessments, vital signs and physical exam



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03167957


Locations
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United States, Michigan
Tolan Park Clinic
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
Matinas BioPharma Nanotechnologies, Inc.

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Responsible Party: Matinas BioPharma Nanotechnologies, Inc.
ClinicalTrials.gov Identifier: NCT03167957     History of Changes
Other Study ID Numbers: MB-70008
First Posted: May 30, 2017    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Matinas BioPharma Nanotechnologies, Inc.:
fluconazole
fluconazole-resistant
Additional relevant MeSH terms:
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Fluconazole
Infection
Communicable Diseases
Candidiasis
Candidiasis, Vulvovaginal
Mycoses
Vulvovaginitis
Vaginitis
Vaginal Diseases
Genital Diseases, Female
Vulvitis
Vulvar Diseases
Amphotericin B
Liposomal amphotericin B
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Bacterial Agents