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

Matinas BioPharma

Status and phase: Withdrawn; Phase 2

Conditions: Yeast Infection; Candidiasis, Vulvovaginal; Vulvovaginal Candidiases; Yeast Infection Vaginal; Vulvovaginitis

Treatments: Drug: Oral Encochleated Amphotericin B (CAMB)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03167957

MB-70008

Details and patient eligibility

About

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).

Full 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.

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

CAMB 200 mg

Experimental group

Description:

200 mg CAMB Oral Amphotericin B

Treatment:

Drug: Oral Encochleated Amphotericin B (CAMB)

Drug: Oral Encochleated Amphotericin B (CAMB)

CAMB 400 mg

Experimental group

Description:

400 mg CAMB Oral Amphotericin B

Treatment:

Drug: Oral Encochleated Amphotericin B (CAMB)

Drug: Oral Encochleated Amphotericin B (CAMB)