Efficacy and Safety Study of Miconazole Lauriad to Treat Oropharyngeal Candidiasis in HIV Patients

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the clinical cure of miconazole Lauriad 50 mg (1x50mg) Bioadhesive buccal tablets compared with clotrimazole troches (5x10mg) after 14 days of treatment (at the test of cure visit, at Day 17-19).

Official Title
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A Comparative Randomized, Double-blind, Double-Dummy, Multicenter Study of the Efficacy and Safety of Miconazole Lauriad 50mg Administered Once a Day and Mycelex Troches (Clotrimazole 10mg) Administered Five Times a Day in the Treatment of Oropharyngeal Candidiasis in Immunocompromised Patients

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: miconazole Lauriad
* Drug: Clotrimazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with clinical picture of oropharyngeal candidiasis Confirmation of oropharyngeal candidiasis by candida culture positive HIV-positive patients Patients 18 years of age Exclusion Criteria: Patients with signs or symptoms of systemic candidiasis Patients with signs or symptoms of esophagitis Pregnant or breast-feeding women Patients who have taken systemic antifungals within the past 30 days Patients who have taken local antifungals within the past 7 days

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Clotrimazole<br>Clotrimazole troches, 10 mg, 5 times per day for 14 days | Drug: Clotrimazole<br>* 10mg troches administered Five Times a Day for 14 days<br>|
| Experimental: miconazole Lauriad<br>Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days | Drug: miconazole Lauriad<br>* 50 mg buccal tablet once a day for 14 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Cure (Defined as a Complete Resolution of Signs and Symptoms) After 14 Days of Treatment at the Test of Cure Visit (Day 17-Day 22) Using Murray Scoring Scale | Murray scoring scale range: extent of oral lesions (signs) 0 (none) to 3 (extensive or confluent), ordinal; symptoms (soreness/burning) 0 (absent) to 3 (severe), ordinal. Clinical cure was defined as a complete resolution of signs and symptoms (extent of oral lesions score = 0, symptoms score = 0). Clinical failure was defined as any patient who failed to be clinically cured by the treatment. | 17 to 22 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Cure at Day 7 (Using Murray Scoring Scale) | Murray scoring scale range: extent of oral lesions (signs) 0 (none) to 3 (extensive or confluent), ordinal; symptoms (soreness/burning) 0 (absent) to 3 (severe), ordinal. Clinical cure was defined as a complete resolution of signs and symptoms (extent of oral lesions score = 0, symptoms score = 0). Clinical failure was defined as any patient who failed to be clinically cured by the treatment. | 7 days | 
| Clinical Success at Test-of-cure Visit (Day 17-22) (Using Murray Scoring Scale) | Murray scoring scale range: extent of oral lesions (signs) 0 (none) to 3 (extensive or confluent), ordinal; symptoms (soreness/burning) 0 (absent) to 3 (severe), ordinal. Clinical success was defined as clinical cure or clinical improvement. Clinical cure was defined as a complete resolution of signs and symptoms (extent of oral lesions score = 0, symptoms score = 0). Clinical improvement was defined as having no visible lesion (extent of lesions score = 0) and minimal symptoms (soreness/burning score <2). Clinical failure was defined as any patient who failed to be clinically cured by the treatment. | 17 to 22 days | 
| Clinical Success at Day 7 (Using Murray Scoring Scale) | Murray scoring scale range: extent of oral lesions (signs) 0 (none) to 3 (extensive or confluent), ordinal; symptoms (soreness/burning) 0 (absent) to 3 (severe), ordinal. Clinical success was defined as clinical cure or clinical improvement. Clinical cure was defined as a complete resolution of signs and symptoms (extent of oral lesions score = 0, symptoms score = 0). Clinical improvement was defined as having no visible lesion (extent of lesions score = 0) and minimal symptoms (soreness/burning score <2). Clinical failure was defined as any patient who failed to be clinically cured by the treatment. | 7 days | 
| Partial Response at Test of Cure Visit (Days 17-22) Using Murray Scoring Scale | Murray scoring scale range: extent of oral lesions (signs) 0 (none) to 3 (extensive or confluent), ordinal; symptoms (soreness/burning) 0 (absent) to 3 (severe), ordinal. Clinical success was defined as clinical cure or clinical improvement. Partial response is having decrease in Murray extent of oral lesions score by at least 1 level and a stable Murray symptoms score, with partial symptom response defined as having a decrease in the Murray symptoms (soreness/burning) score by at least 1 level and a stable Murray extent of oral lesions score, and partial clinical/symptom response defined as decrease in Murray extent of oral lesions score by at least 1 level and a decrease in the Murray symptoms (soreness/burning) score by at least 1 level | 17 to 22 days | 
| Mycological Cure at the Test of Cure Visit (Day 17-22) | Mycological cure was defined as a patient who had no yeast isolated when oral specimens were cultured for fungi. | 17 to 22 days | 
| Relapse at the Late Post-Therapy Visit (Day 35-38) | Number of patients represents the number of participants who completed visit 6 (the late post-therapy visit on Days 35-38) and had been a clinical success at test-of-cure visit (visit 5). For this subset of participants, relapse was defined as a patient who responded to treatment by clinical cure or improvement (i.e., clinical success) on Days 17-22 at the test-of-cure visit (visit 5) and subsequently had an increase in the extent of oral lesions or symptoms, as assessed at the late post-therapy visit on Days 35-38 (visit 6). No relapse indicates participants who were considered a clinical success at visit 5 and did not have a subsequent increase in the extent of oral lesions or symptoms, as assessed at the late post-therapy visit (visit 6). The remaining number of participants in the Intent-to-Treat population who did not meet the criteria for relapse assessment at visit 6 is listed under Not Analyzed-ITT. | 35 to 38 days | 
| Oral Discomfort Using Visual Analog Scale (VAS) | Visual analog scale was used by the patient in the patient diary. The scale ranged from 0 (no oral discomfort) to 10 (maximum oral discomfort) | 14 days | 
| General and Local Tolerability and Oral Discomfort | Overall local adverse reactions, including gingival inflammation, gum pain, alterations in taste of food when eating, alterations in taste when not eating, and dry mouth. Visit 4 occurred on Day 14. | 14 days | 
| Duration of Adhesion of Miconazole Lauriad 50 mg Mucoadhesive Buccal Tablet | The mean durations of adhesion from initiation of treatment to Day 14 of miconazole Lauriad 50 mg mucoadhesive buccal tablet (or, in the case of the Clotrimazole troches treatment arm, the placebo mucoadhesive buccal tablet) were rounded to the nearest hour | 14 days | 
| Systemic Exposure of Miconazole Lauriad 50 mg Bioadhesive Buccal Tablet | Number of patients with detectable plasma concentration at Visit 3 (day 7) | 7 days | 
| Susceptibility of Candida Species by Microdilution Test | minimum inhibitory concentration (MIC) in nonresponders at test-of-cure visit | Initiation of treatment to Day 17 to 22 | 
| Treatment Compliance | Number of patients who were 100% compliant with the treatment regimen | Initiation of treatment to Day 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Miconazole Lauriad, Oropharyngeal candidiasis, HIV patients, Mycology, Clinical picture of Oropharyngeal candidiasis, Candida culture positive, Treatment Experienced