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

• Sponsor: Viamet (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01891331
• Collaborator: (none)
• Enrollment: 55
• Locations: 8
• Arms: 4
• Duration (Months): 16
• Patients Per Site: 6.9
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Candidiasis, Vulvovaginal	Drug: VT-1161; Drug: Fluconazole	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 55 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• 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 Start Date: Aug 1, 2013
• Actual Primary Completion Date: Dec 1, 2014
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: VT-1161 300mg QD	Drug: VT-1161
Experimental: VT-1161 600mg QD	Drug: VT-1161
Experimental: VT-1161 600mg BID	Drug: VT-1161
Active Comparator: Fluconazole 150mg	Drug: Fluconazole

Outcome Measures

Primary Outcome Measures

1. 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: 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Altus Research	Lake Worth	Florida	United States	33461
2	Healthcare Clinical Data, Inc	North Miami	Florida	United States	33161
3	SUNY Downstate Medical Center	Brooklyn	New York	United States	11203
4	Lyndhurst Clinical Research	Raleigh	North Carolina	United States	27607
5	Lyndhurst Clinical Research	Winston-Salem	North Carolina	United States	27103
6	Drexel Vaginitis Center	Philadelphia	Pennsylvania	United States	19102
7	Brownstone Clinical Trials, LLC	Irving	Texas	United States	75062
8	Harborview ID Research Clinic	Seattle	Washington	United States	98104

Sponsors and Collaborators

• Viamet

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Viamet
• ClinicalTrials.gov Identifier: NCT01891331
• Other Study ID Numbers: VMT-VT-1161-CL-004
• First Posted: Jul 3, 2013
• Last Update Posted: Aug 1, 2018
• Last Verified: Jul 1, 2018

• Additional relevant MeSH terms: Candidiasis; Candidiasis, Vulvovaginal; Fluconazole

Study Results

Participant Flow

Arm/Group Title	VT-1161 300mg QD	VT-1161 600mg QD	VT-1161 600mg BID	Fluconazole 150mg
Arm/Group Description	VT-1161 300mg once daily for 3 days	VT-1161 600mg once daily for 3 days	VT-1161 600mg twice daily for 3 days	Single dose of fluconazole 150mg
Period Title: Overall Study
STARTED	14	12	14	15
COMPLETED	12	10	13	13
NOT COMPLETED	2	2	1	2

Baseline Characteristics

Arm/Group Title	VT-1161 300mg QD	VT-1161 600mg QD	VT-1161 600mg BID	Fluconazole 150mg	Total
Arm/Group Description	Total of all reporting groups
Overall Participants	14	12	14	15	55
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	34.4 (12.01)	38.2 (11.77)	27.6 (7.37)	31.3 (8.22)	32.7 (10.4)
Sex: Female, Male (Count of Participants)
Female	14 100%	12 100%	14 100%	15 100%	55 100%
Male	0 0%	0 0%	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Percentage of Subjects With Therapeutic Cure at 28 Days for All-Analysis Population
Description	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.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	VT-1161 300mg QD	VT-1161 600mg QD	VT-1161 600mg BID	Fluconazole 150mg
Arm/Group Description
Measure Participants	14	12	14	15
Count of Participants [Participants]	9 64.3%	9 75%	11 78.6%	10 66.7%

Adverse Events

Arm/Group Title	VT-1161 300mg QD		VT-1161 600mg QD		VT-1161 600mg BID		Fluconazole 150mg
Arm/Group Description
All Cause Mortality
	VT-1161 300mg QD		VT-1161 600mg QD		VT-1161 600mg BID		Fluconazole 150mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	VT-1161 300mg QD		VT-1161 600mg QD		VT-1161 600mg BID		Fluconazole 150mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/14 (0%)		0/12 (0%)		0/14 (0%)		0/15 (0%)
Other (Not Including Serious) Adverse Events
	VT-1161 300mg QD		VT-1161 600mg QD		VT-1161 600mg BID		Fluconazole 150mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/14 (71.4%)		6/12 (50%)		3/14 (21.4%)		10/15 (66.7%)
Cardiac disorders
Palpitations	0/14 (0%)		1/12 (8.3%)		0/14 (0%)		0/15 (0%)
Eye disorders
Conjunctivitis	0/14 (0%)		0/12 (0%)		0/14 (0%)		1/15 (6.7%)
Gastrointestinal disorders
Abdominal Pain	0/14 (0%)		0/12 (0%)		1/14 (7.1%)		0/15 (0%)
Nausea	1/14 (7.1%)		2/12 (16.7%)		0/14 (0%)		0/15 (0%)
Infections and infestations
Conjunctivitis Bacterial	1/14 (7.1%)		0/12 (0%)		0/14 (0%)		0/15 (0%)
Ear Infection	1/14 (7.1%)		0/12 (0%)		0/14 (0%)		1/15 (6.7%)
Herpes Simplex	0/14 (0%)		0/12 (0%)		0/14 (0%)		1/15 (6.7%)
Influenza	0/14 (0%)		0/12 (0%)		0/14 (0%)		1/15 (6.7%)
Nasopharyngitis	1/14 (7.1%)		0/12 (0%)		0/14 (0%)		2/15 (13.3%)
Esophageal Candidiasis	0/14 (0%)		0/12 (0%)		0/14 (0%)		1/15 (6.7%)
Pharyngitis	0/14 (0%)		0/12 (0%)		1/14 (7.1%)		0/15 (0%)
Sinusitits	1/14 (7.1%)		0/12 (0%)		0/14 (0%)		0/15 (0%)
Trichamoniasis	1/14 (7.1%)		0/12 (0%)		0/14 (0%)		0/15 (0%)
Upper Respiratory Tract Infection	1/14 (7.1%)		1/12 (8.3%)		0/14 (0%)		0/15 (0%)
Urinary Tract Infection	1/14 (7.1%)		1/12 (8.3%)		0/14 (0%)		0/15 (0%)
Vaginitis Bacterial	2/14 (14.3%)		1/12 (8.3%)		0/14 (0%)		2/15 (13.3%)
Injury, poisoning and procedural complications
Laceration	0/14 (0%)		1/12 (8.3%)		0/14 (0%)		0/15 (0%)
Investigations
Liver Function Test Abnormal	0/14 (0%)		1/12 (8.3%)		0/14 (0%)		0/15 (0%)
Musculoskeletal and connective tissue disorders
Back Pain	0/14 (0%)		0/12 (0%)		0/14 (0%)		1/15 (6.7%)
Pain in Extremity	1/14 (7.1%)		0/12 (0%)		0/14 (0%)		0/15 (0%)
Nervous system disorders
Carpal Tunnel Syndrome	0/14 (0%)		1/12 (8.3%)		0/14 (0%)		0/15 (0%)
Dizziness	0/14 (0%)		1/12 (8.3%)		0/14 (0%)		0/15 (0%)
Dysgeusia	0/14 (0%)		1/12 (8.3%)		0/14 (0%)		0/15 (0%)
Headache	0/14 (0%)		1/12 (8.3%)		0/14 (0%)		0/15 (0%)
Pregnancy, puerperium and perinatal conditions
Pregnancy	0/14 (0%)		0/12 (0%)		0/14 (0%)		2/15 (13.3%)
Psychiatric disorders
Insomnia	0/14 (0%)		0/12 (0%)		0/14 (0%)		1/15 (6.7%)
Renal and urinary disorders
Urine Odor Abnormal	0/14 (0%)		1/12 (8.3%)		0/14 (0%)		0/15 (0%)
Reproductive system and breast disorders
Dysmenorrhea	0/14 (0%)		0/12 (0%)		0/14 (0%)		1/15 (6.7%)
Dyspareunia	1/14 (7.1%)		0/12 (0%)		0/14 (0%)		0/15 (0%)
Fibrocystic Breast Disease	0/14 (0%)		1/12 (8.3%)		0/14 (0%)		0/15 (0%)
Metrorrhagia	1/14 (7.1%)		0/12 (0%)		0/14 (0%)		0/15 (0%)
Uterine Hemorrhage	0/14 (0%)		0/12 (0%)		0/14 (0%)		1/15 (6.7%)
Vaginal Discharge	0/14 (0%)		0/12 (0%)		0/14 (0%)		1/15 (6.7%)
Vulvovaginal Pruritus	0/14 (0%)		1/12 (8.3%)		1/14 (7.1%)		0/15 (0%)
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain	1/14 (7.1%)		0/12 (0%)		0/14 (0%)		0/15 (0%)
Skin and subcutaneous tissue disorders
Dermatitis Contact	1/14 (7.1%)		0/12 (0%)		0/14 (0%)		0/15 (0%)
Erythema	0/14 (0%)		0/12 (0%)		1/14 (7.1%)		0/15 (0%)
Pruritus	0/14 (0%)		0/12 (0%)		0/14 (0%)		1/15 (6.7%)
Urticaria	1/14 (7.1%)		0/12 (0%)		0/14 (0%)		0/15 (0%)
Vascular disorders
Hematoma	0/14 (0%)		0/12 (0%)		0/14 (0%)		1/15 (6.7%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Neither institution nor principal investigator shall publish the results of the trial without prior written consent of the sponsor, which it may withhold in its sole discretion.