A Study to Evaluate the Efficacy and Safety of Oral VT-1161 in Patients With Acute Vaginal Candidiasis (Yeast Infection)
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
1 other identifier
interventional
55
1 country
8
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2013
Shorter than P25 for phase_2
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 17, 2013
CompletedFirst Posted
Study publicly available on registry
July 3, 2013
CompletedStudy Start
First participant enrolled
August 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedResults Posted
Study results publicly available
July 6, 2018
CompletedAugust 1, 2018
July 1, 2018
1.3 years
June 17, 2013
June 6, 2018
July 5, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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: 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.
4 weeks
Study Arms (4)
VT-1161 300mg QD
EXPERIMENTALVT-1161 600mg QD
EXPERIMENTALVT-1161 600mg BID
EXPERIMENTALFluconazole 150mg
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Viametlead
Study Sites (8)
Altus Research
Lake Worth, Florida, 33461, United States
Healthcare Clinical Data, Inc
North Miami, Florida, 33161, United States
SUNY Downstate Medical Center
Brooklyn, New York, 11203, United States
Lyndhurst Clinical Research
Raleigh, North Carolina, 27607, United States
Lyndhurst Clinical Research
Winston-Salem, North Carolina, 27103, United States
Drexel Vaginitis Center
Philadelphia, Pennsylvania, 19102, United States
Brownstone Clinical Trials, LLC
Irving, Texas, 75062, United States
Harborview ID Research Clinic
Seattle, Washington, 98104, United States
Related Publications (2)
Vanreppelen G, Nysten J, Baldewijns S, Sillen M, Donders G, Van Dijck P. Oteseconazole (VIVOJA) for prevention of recurrent vulvovaginal candidiasis. Trends Pharmacol Sci. 2023 Jan;44(1):64-65. doi: 10.1016/j.tips.2022.10.004. Epub 2022 Nov 14. No abstract available.
PMID: 36396498DERIVEDBrand 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.
PMID: 32818963DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Neil Moore
- Organization
- Viamet Pharmaceuticals Inc
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 17, 2013
First Posted
July 3, 2013
Study Start
August 1, 2013
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
August 1, 2018
Results First Posted
July 6, 2018
Record last verified: 2018-07