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

Phase 2

Completed

• Conditions: Candidiasis, Vulvovaginal
• Interventions: Drug: VT-1161; Drug: Fluconazole

• Registration Number: NCT01891331
• Lead Sponsor: Viamet

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-06-17
• Study First Submitted QC: 2013-07-02
• Study First Posted: 2013-07-03
• Study Start: 2013-08
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Results First Submitted: 2018-06-06
• Results First Submitted QC: 2018-06-06
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-05
• Results First Posted: 2018-07-06
• Last Update Posted: 2018-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VT-1161 300mg QD	VT-1161	-
VT-1161 600mg BID	VT-1161	-
VT-1161 600mg QD	VT-1161	-
Fluconazole 150mg	Fluconazole	-

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects With Therapeutic Cure at 28 Days for All-Analysis Population	4 weeks	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: 1. complete resolution of signs and symptoms pertaining to vulvovaginal candidiasis; 2. any new sign or symptom observed at 28 days determined by investigator to not be related to vulvovaginal candidiasis; 3. no use of any other antifungal drug therapy for treatment of vulvovaginal irritation and/or pruritus by subject.

Trial Locations

Locations (7)

Healthcare Clinical Data, Inc; 🇺🇸 North Miami, Florida, United States

Harborview ID Research Clinic; 🇺🇸 Seattle, Washington, United States

SUNY Downstate Medical Center; 🇺🇸 Brooklyn, New York, United States

Altus Research; 🇺🇸 Lake Worth, Florida, United States

Brownstone Clinical Trials, LLC; 🇺🇸 Irving, Texas, United States

Lyndhurst Clinical Research; 🇺🇸 Winston-Salem, North Carolina, United States

Drexel Vaginitis Center; 🇺🇸 Philadelphia, Pennsylvania, United States