NCT03167957

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

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Matinas BioPharma Nanotechnologies, Inc. · Industry
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

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.

Conditions

• Vulvovaginal Candidiases
• Yeast Infection
• Vulvovaginitis
• Yeast Infection Vaginal
• Candidiasis, Vulvovaginal

Interventions

Type	Name	Description
DRUG	Oral Encochleated Amphotericin B (CAMB)	Lipid-crystal nano-particle formulation amphotericin B
DRUG	Oral Encochleated Amphotericin B (CAMB)	Lipid-crystal nano-particle formulation amphotericin B

Timeline

• Start date: 2019-12-01
• Primary completion: 2020-12-01
• Completion: 2020-12-01
• First posted: 2017-05-30
• Last updated: 2019-03-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study