Clinical trial NCT01891331: A Study to Evaluate the Efficacy and Safety of Oral VT-1161 in Patients With Acute Vaginal Candidiasis (Yeast Infection)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Candidiasis, Vulvovaginal
Lead sponsor: Viamet
Sponsor class: INDUSTRY
First posted: 2013-07-03
Enrollment: 55
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Subjects With Therapeutic Cure at 28 Days for All-Analysis Population
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lake Worth
country: United States
facility: Altus Research
state: Florida
city: North Miami
country: United States
facility: Healthcare Clinical Data, Inc
state: Florida
city: Brooklyn
country: United States
facility: SUNY Downstate Medical Center
state: New York
city: Raleigh
country: United States
facility: Lyndhurst Clinical Research
state: North Carolina
city: Winston-Salem
country: United States
facility: Lyndhurst Clinical Research
state: North Carolina
city: Philadelphia
country: United States
facility: Drexel Vaginitis Center
state: Pennsylvania
city: Irving
country: United States
facility: Brownstone Clinical Trials, LLC
state: Texas
city: Seattle
country: United States
facility: Harborview ID Research Clinic
state: Washington
Study officials:
References:
citation: Brand SR, Sobel JD, Nyirjesy P, Ghannoum MA, Schotzinger RJ, Degenhardt TP. A Randomized Phase 2 Study of VT-1161 for the Treatment of Acute Vulvovaginal Candidiasis. Clin Infect Dis. 2021 Oct 5;73(7):e1518-e1524. doi: 10.1093/cid/ciaa1204.