A Study to Evaluate the Efficacy and Safety of Oral VT-1161 in Patients With Acute Vaginal Candidiasis (Yeast Infection)

Candidiasis, Vulvovaginal Clinical Trial

Official title:

A Phase 2A, Randomized, Double-Blind, Dose Ranging Study to Evaluate the Efficacy and Safety of VT-1161 Oral Tablets Compared to Fluconazole in the Treatment of Patients With Moderate to Severe Acute Vulvovaginal Candidiasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01891331
• Other study ID #: VMT-VT-1161-CL-004
• Status: Completed
• Phase: Phase 2
• Start date: August 2013
• Est. completion date: December 2014

Study information

• Verified date: July 2018
• Source: Viamet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if the novel oral agent VT-1161 is safe and effective in treating patients with acute vulvovaginal candidiasis (also referred to as yeast infection). VT-1161 has been designed to inhibit CYP51, an enzyme essential for fungal growth. Inhibition of CYP51 results in the accumulation of chemicals know to be toxic to the fungus. CYP51 is the molecular target of the class of drugs referred to as 'azole antifungals'. All currently approved azole drugs have poor selectivity for CYP51 and this results in many of the side effects associated with the azole antifungals. The safety profile of the class similarly limits use in chronic treatment of non-life-threatening fungal infections. VT-1161 has been design to be safer and more active against the fungal species typically responsible for vaginal yeast infections (i.e. vulvovaginal candidiasis).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Key Inclusion Criteria:

• Females =18 and <65 years

• Clinical diagnosis of symptomatic acute VVC

• Positive KOH .At least one vulvovaginal sign (vulvovaginal erythema, edema, or excoriation).

• At least one vulvovaginal symptom (vulvovaginal itching, burning, or irritation)

• A minimum composite vulvovaginal signs and symptoms score of =6

• must be be able to swallow capsules

Exclusion Criteria:

• Evidence of major organ system disease

• History of cervical cancer

• History of diabetes mellitus

• Pregnant

• Recent use of systemic antifungal drugs or systemic antimicrobial therapy for any reason

• Recent use of drugs to treat vaginal infections

• Recent use of immunosuppressive therapies

Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Vulvovaginal

Intervention

Drug:
• VT-1161

• Fluconazole

Locations

Country	Name	City	State
United States	SUNY Downstate Medical Center	Brooklyn	New York
United States	Brownstone Clinical Trials, LLC	Irving	Texas
United States	Altus Research	Lake Worth	Florida
United States	Healthcare Clinical Data, Inc	North Miami	Florida
United States	Drexel Vaginitis Center	Philadelphia	Pennsylvania
United States	Lyndhurst Clinical Research	Raleigh	North Carolina
United States	Harborview ID Research Clinic	Seattle	Washington
United States	Lyndhurst Clinical Research	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Viamet

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Subjects With Therapeutic Cure at 28 Days for All-Analysis Population	For this trial, therapeutic cure was defined as mycological AND clinical cure. Mycological cure was defined as a negative fungal culture for Candida species. Clinical cure was defined as all of the following: complete resolution of signs and symptoms pertaining to vulvovaginal candidiasis; any new sign or symptom observed at 28 days determined by investigator to not be related to vulvovaginal candidiasis; no use of any other antifungal drug therapy for treatment of vulvovaginal irritation and/or pruritus by subject.	4 weeks