Efficacy and Safety Study of Miconazole Lauriad to Treat Oropharyngeal Candidiasis in HIV Patients
NCT ID: NCT00390780
Last Updated: 2013-09-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
578 participants
INTERVENTIONAL
2006-07-31
2008-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Clotrimazole
Clotrimazole troches, 10 mg, 5 times per day for 14 days
Clotrimazole
10mg troches administered Five Times a Day for 14 days
miconazole Lauriad
Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
miconazole Lauriad
50 mg buccal tablet once a day for 14 days
Interventions
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miconazole Lauriad
50 mg buccal tablet once a day for 14 days
Clotrimazole
10mg troches administered Five Times a Day for 14 days
Eligibility Criteria
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Inclusion Criteria
* Confirmation of oropharyngeal candidiasis by candida culture positive
* HIV-positive patients
* Patients 18 years of age
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Valerio Therapeutics
INDUSTRY
Responsible Party
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Locations
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University of Alabama, Department of diagnostic Sciences School of Dentistry
Birmingham, Alabama, United States
L.A. Gay & Lesbian center, Health & Mental, health services
Los Angeles, California, United States
East Bay AIDS Center
Oakland, California, United States
1401 Noth Palm Canyon
Palm Springs, California, United States
University of Connecticut, School of dental medicine
Farmington, Connecticut, United States
Therafirst Medical Center
Fort Lauderdale, Florida, United States
Fort Lauderdale, Florida, United States
Ryan White Title III Clinic
LaBelle, Florida, United States
University of Miami
Miami, Florida, United States
Triple O Medical Services
West Palm Beach, Florida, United States
Department of oral medicine and diagnostic sciences UIC college of dentistry
Chicago, Illinois, United States
Plus Clinic, University of Maryland Dental school
Baltimore, Maryland, United States
Henry Ford Hospital and Wayne State University, Division of infectious diseases
Detroit, Michigan, United States
AIDS Community Research Initiative of America
New York, New York, United States
Department Diagnostics Sciences, UNC
Chapel Hill, North Carolina, United States
East Carolina University, Brody School of Medicine
Greenville, North Carolina, United States
University of Oklahoma, College of medicine
Tulsa, Oklahoma, United States
Lehigh Valley Hospital Clinical Research Department of Medicine
Allentown, Pennsylvania, United States
Roger Williams Medical Center
Providence, Rhode Island, United States
Bering Omega Dental Clinic
Houston, Texas, United States
Eastern Virginia Medical Center, Center for comprehensive care of immune deficiency
Norfolk, Virginia, 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
Health Sciences Center
Winnipeg, Manitoba, Canada
University of Ottawa Health Services
Ottawa, Ontario, Canada
Montreal Chest Institutes immunodeficiency clinic
Montreal, Quebec, Canada
Montreal General Hospital
Montreal, Quebec, Canada
Countries
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Other Identifiers
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BA/2004/01/04
Identifier Type: -
Identifier Source: org_study_id