Efficacy and Safety Study of Miconazole Lauriad to Treat Oropharyngeal Candidiasis in HIV Patients
- Registration Number
- NCT00390780
- Lead Sponsor
- Valerio Therapeutics
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 578
- Patients with clinical picture of oropharyngeal candidiasis
- Confirmation of oropharyngeal candidiasis by candida culture positive
- HIV-positive patients
- Patients 18 years of age
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description miconazole Lauriad miconazole Lauriad Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days Clotrimazole Clotrimazole Clotrimazole troches, 10 mg, 5 times per day for 14 days
- Primary Outcome Measures
Name Time Method 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 17 to 22 days 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.
- Secondary Outcome Measures
Name Time Method Clinical Cure at Day 7 (Using Murray Scoring Scale) 7 days 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.
Clinical Success at Test-of-cure Visit (Day 17-22) (Using Murray Scoring Scale) 17 to 22 days 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.
Clinical Success at Day 7 (Using Murray Scoring Scale) 7 days 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.
Partial Response at Test of Cure Visit (Days 17-22) Using Murray Scoring Scale 17 to 22 days 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
Mycological Cure at the Test of Cure Visit (Day 17-22) 17 to 22 days Mycological cure was defined as a patient who had "no yeast isolated" when oral specimens were cultured for fungi.
Relapse at the Late Post-Therapy Visit (Day 35-38) 35 to 38 days "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".
Oral Discomfort Using Visual Analog Scale (VAS) 14 days 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)
General and Local Tolerability and Oral Discomfort 14 days 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.
Duration of Adhesion of Miconazole Lauriad 50 mg Mucoadhesive Buccal Tablet 14 days 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
Systemic Exposure of Miconazole Lauriad 50 mg Bioadhesive Buccal Tablet 7 days Number of patients with detectable plasma concentration at Visit 3 (day 7)
Susceptibility of Candida Species by Microdilution Test Initiation of treatment to Day 17 to 22 minimum inhibitory concentration (MIC) in nonresponders at test-of-cure visit
Treatment Compliance Initiation of treatment to Day 14 Number of patients who were 100% compliant with the treatment regimen
Trial Locations
- Locations (26)
Montreal General Hospital
🇨🇦Montreal, Quebec, Canada
University of Ottawa Health Services
🇨🇦Ottawa, Ontario, Canada
University of Connecticut, School of dental medicine
🇺🇸Farmington, Connecticut, United States
Plus Clinic, University of Maryland Dental school
🇺🇸Baltimore, Maryland, United States
Department of oral medicine and diagnostic sciences UIC college of dentistry
🇺🇸Chicago, Illinois, United States
Roger Williams Medical Center
🇺🇸Providence, Rhode Island, United States
Eastern Virginia Medical Center, Center for comprehensive care of immune deficiency
🇺🇸Norfolk, Virginia, United States
Henry Ford Hospital and Wayne State University, Division of infectious diseases
🇺🇸Detroit, Michigan, United States
L.A. Gay & Lesbian center, Health & Mental, health services
🇺🇸Los Angeles, California, United States
University of Alabama, Department of diagnostic Sciences School of Dentistry
🇺🇸Birmingham, Alabama, United States
AIDS Community Research Initiative of America
🇺🇸New-York, New York, United States
Lehigh Valley Hospital Clinical Research Department of Medicine
🇺🇸Allentown, Pennsylvania, United States
Health Sciences Center
🇨🇦Winnipeg, Manitoba, Canada
Bering Omega Dental Clinic
🇺🇸Houston, Texas, United States
East Carolina University, Brody School of Medicine
🇺🇸Greenville, North Carolina, United States
1401 Noth Palm Canyon
🇺🇸Palm Springs, California, United States
Therafirst Medical Center
🇺🇸Fort Lauderdale, Florida, United States
University of Miami
🇺🇸Miami, Florida, United States
Ryan White Title III Clinic
🇺🇸Labelle, Florida, United States
Triple O Medical Services
🇺🇸West Palm Beach, Florida, United States
Department Diagnostics Sciences, UNC
🇺🇸Chapel Hill, North Carolina, United States
Downtown Infectious Disease Clinic
🇨🇦Vancouver, British Columbia, Canada
Providence Health Center British Columbia Centre for excellence in HIV/AIDS
🇨🇦Vancouver, British Columbia, Canada
University of Oklahoma, College of medicine
🇺🇸Tulsa, Oklahoma, United States
Montreal Chest Institutes immunodeficiency clinic
🇨🇦Montreal, Quebec, Canada
East Bay AIDS Center
🇺🇸Oakland, California, United States