Clinical trial NCT00390780: Efficacy and Safety Study of Miconazole Lauriad to Treat Oropharyngeal Candidiasis in HIV Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Keywords: Miconazole Lauriad
Oropharyngeal candidiasis
HIV patients
Mycology
Clinical picture of Oropharyngeal candidiasis
Candida culture positive
Treatment Experienced
Lead sponsor: Valerio Therapeutics
Sponsor class: INDUSTRY
First posted: 2006-10-20
Enrollment: 578
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 17 to 22 days
Secondary outcomes:
measure: Clinical Cure at Day 7 (Using Murray Scoring Scale)
timeFrame: 7 days
measure: Clinical Success at Test-of-cure Visit (Day 17-22) (Using Murray Scoring Scale)
timeFrame: 17 to 22 days
measure: Clinical Success at Day 7 (Using Murray Scoring Scale)
timeFrame: 7 days
measure: Partial Response at Test of Cure Visit (Days 17-22) Using Murray Scoring Scale
timeFrame: 17 to 22 days
measure: Mycological Cure at the Test of Cure Visit (Day 17-22)
timeFrame: 17 to 22 days
measure: Relapse at the Late Post-Therapy Visit (Day 35-38)
timeFrame: 35 to 38 days
measure: Oral Discomfort Using Visual Analog Scale (VAS)
timeFrame: 14 days
measure: General and Local Tolerability and Oral Discomfort
timeFrame: 14 days
measure: Duration of Adhesion of Miconazole Lauriad 50 mg Mucoadhesive Buccal Tablet
timeFrame: 14 days
measure: Systemic Exposure of Miconazole Lauriad 50 mg Bioadhesive Buccal Tablet
timeFrame: 7 days
measure: Susceptibility of Candida Species by Microdilution Test
timeFrame: Initiation of treatment to Day 17 to 22
measure: Treatment Compliance
timeFrame: Initiation of treatment to Day 14
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama, Department of diagnostic Sciences School of Dentistry
state: Alabama
city: Los Angeles
country: United States
facility: L.A. Gay & Lesbian center, Health & Mental, health services
state: California
city: Oakland
country: United States
facility: East Bay AIDS Center
state: California
city: Palm Springs
country: United States
facility: 1401 Noth Palm Canyon
state: California
city: Farmington
country: United States
facility: University of Connecticut, School of dental medicine
state: Connecticut
city: Fort Lauderdale
country: United States
facility: Therafirst Medical Center
state: Florida
city: Fort Lauderdale
country: United States
state: Florida
city: Labelle
country: United States
facility: Ryan White Title III Clinic
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: West Palm Beach
country: United States
facility: Triple O Medical Services
state: Florida
city: Chicago
country: United States
facility: Department of oral medicine and diagnostic sciences UIC college of dentistry
state: Illinois
city: Baltimore
country: United States
facility: Plus Clinic, University of Maryland Dental school
state: Maryland
city: Detroit
country: United States
facility: Henry Ford Hospital and Wayne State University, Division of infectious diseases
state: Michigan
city: New-York
country: United States
facility: AIDS Community Research Initiative of America
state: New York
city: Chapel Hill
country: United States
facility: Department Diagnostics Sciences, UNC
state: North Carolina
city: Greenville
country: United States
facility: East Carolina University, Brody School of Medicine
state: North Carolina
city: Tulsa
country: United States
facility: University of Oklahoma, College of medicine
state: Oklahoma
city: Allentown
country: United States
facility: Lehigh Valley Hospital Clinical Research Department of Medicine
state: Pennsylvania
city: Providence
country: United States
facility: Roger Williams Medical Center
state: Rhode Island
city: Houston
country: United States
facility: Bering Omega Dental Clinic
state: Texas
city: Norfolk
country: United States
facility: Eastern Virginia Medical Center, Center for comprehensive care of immune deficiency
state: Virginia
city: Vancouver
country: Canada
facility: Downtown Infectious Disease Clinic
state: British Columbia
city: Vancouver
country: Canada
facility: Providence Health Center British Columbia Centre for excellence in HIV/AIDS
state: British Columbia
city: Winnipeg
country: Canada
facility: Health Sciences Center
state: Manitoba
city: Ottawa
country: Canada
facility: University of Ottawa Health Services
state: Ontario
city: Montreal
country: Canada
facility: Montreal Chest Institutes immunodeficiency clinic
state: Quebec
city: Montreal
country: Canada
facility: Montreal General Hospital
state: Quebec
Study officials:
References: