Efficacy and Safety Study of Miconazole Lauriad to Treat Oropharyngeal Candidiasis in HIV Patients
Completed · Phase 3
Conditions studied: HIV Infections
In brief
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).
Key facts
- Study ID
- NCT00390780
- Run by
- Valerio Therapeutics
- People needed
- 578
- Starts
- 2006-07-01
- Expected to finish
- 2008-01-01
- Last updated by the study team
- 2013-09-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients with clinical picture of oropharyngeal candidiasis
- Confirmation of oropharyngeal candidiasis by candida culture positive
- HIV-positive patients
- Patients 18 years of age
You may not qualify if…
- 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
Where it is running
- 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
- Study site — 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
Full record on ClinicalTrials.gov
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