Back to resultsEfficacy and Safety Study of Miconazole Lauriad to Treat Oropharyngeal Candidiasis in HIV Patients
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
miconazole Lauriad
Clotrimazole
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Miconazole Lauriad, Oropharyngeal candidiasis, HIV patients, Mycology, Clinical picture of Oropharyngeal candidiasis, Candida culture positive, Treatment Experienced
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
Sites / Locations
- University of Alabama, Department of diagnostic Sciences School of Dentistry
- L.A. Gay & Lesbian center, Health & Mental, health services
- East Bay AIDS Center
- 1401 Noth Palm Canyon
- University of Connecticut, School of dental medicine
- Therafirst Medical Center
- Ryan White Title III Clinic
- University of Miami
- Triple O Medical Services
- Department of oral medicine and diagnostic sciences UIC college of dentistry
- Plus Clinic, University of Maryland Dental school
- Henry Ford Hospital and Wayne State University, Division of infectious diseases
- AIDS Community Research Initiative of America
- Department Diagnostics Sciences, UNC
- East Carolina University, Brody School of Medicine
- University of Oklahoma, College of medicine
- Lehigh Valley Hospital Clinical Research Department of Medicine
- Roger Williams Medical Center
- Bering Omega Dental Clinic
- Eastern Virginia Medical Center, Center for comprehensive care of immune deficiency
- Downtown Infectious Disease Clinic
- Providence Health Center British Columbia Centre for excellence in HIV/AIDS
- Health Sciences Center
- University of Ottawa Health Services
- Montreal Chest Institutes immunodeficiency clinic
- Montreal General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Clotrimazole
miconazole Lauriad
Arm Description
Clotrimazole troches, 10 mg, 5 times per day for 14 days
Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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
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.
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".
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)
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.
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
Systemic Exposure of Miconazole Lauriad 50 mg Bioadhesive Buccal Tablet
Number of patients with detectable plasma concentration at Visit 3 (day 7)
Susceptibility of Candida Species by Microdilution Test
minimum inhibitory concentration (MIC) in nonresponders at test-of-cure visit
Treatment Compliance
Number of patients who were 100% compliant with the treatment regimen
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00390780
Brief Title
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
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
January 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Onxeo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Miconazole Lauriad, Oropharyngeal candidiasis, HIV patients, Mycology, Clinical picture of Oropharyngeal candidiasis, Candida culture positive, Treatment Experienced
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
578 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Clotrimazole
Arm Type
Active Comparator
Arm Description
Clotrimazole troches, 10 mg, 5 times per day for 14 days
Arm Title
miconazole Lauriad
Arm Type
Experimental
Arm Description
Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
Intervention Type
Drug
Intervention Name(s)
miconazole Lauriad
Intervention Description
50 mg buccal tablet once a day for 14 days
Intervention Type
Drug
Intervention Name(s)
Clotrimazole
Intervention Description
10mg troches administered Five Times a Day for 14 days
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
17 to 22 days
Secondary Outcome Measure Information:
Title
Clinical Cure at Day 7 (Using Murray Scoring Scale)
Description
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.
Time Frame
7 days
Title
Clinical Success at Test-of-cure Visit (Day 17-22) (Using Murray Scoring Scale)
Description
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.
Time Frame
17 to 22 days
Title
Clinical Success at Day 7 (Using Murray Scoring Scale)
Description
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.
Time Frame
7 days
Title
Partial Response at Test of Cure Visit (Days 17-22) Using Murray Scoring Scale
Description
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
Time Frame
17 to 22 days
Title
Mycological Cure at the Test of Cure Visit (Day 17-22)
Description
Mycological cure was defined as a patient who had "no yeast isolated" when oral specimens were cultured for fungi.
Time Frame
17 to 22 days
Title
Relapse at the Late Post-Therapy Visit (Day 35-38)
Description
"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".
Time Frame
35 to 38 days
Title
Oral Discomfort Using Visual Analog Scale (VAS)
Description
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)
Time Frame
14 days
Title
General and Local Tolerability and Oral Discomfort
Description
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.
Time Frame
14 days
Title
Duration of Adhesion of Miconazole Lauriad 50 mg Mucoadhesive Buccal Tablet
Description
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
Time Frame
14 days
Title
Systemic Exposure of Miconazole Lauriad 50 mg Bioadhesive Buccal Tablet
Description
Number of patients with detectable plasma concentration at Visit 3 (day 7)
Time Frame
7 days
Title
Susceptibility of Candida Species by Microdilution Test
Description
minimum inhibitory concentration (MIC) in nonresponders at test-of-cure visit
Time Frame
Initiation of treatment to Day 17 to 22
Title
Treatment Compliance
Description
Number of patients who were 100% compliant with the treatment regimen
Time Frame
Initiation of treatment to Day 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University of Alabama, Department of diagnostic Sciences School of Dentistry
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-00007
Country
United States
Facility Name
L.A. Gay & Lesbian center, Health & Mental, health services
City
Los Angeles
State/Province
California
ZIP/Postal Code
90028
Country
United States
Facility Name
East Bay AIDS Center
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
1401 Noth Palm Canyon
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Facility Name
University of Connecticut, School of dental medicine
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
Facility Name
Therafirst Medical Center
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
City
Fort Lauderdale
State/Province
Florida
Country
United States
Facility Name
Ryan White Title III Clinic
City
Labelle
State/Province
Florida
ZIP/Postal Code
33935
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Triple O Medical Services
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
21201
Country
United States
Facility Name
Department of oral medicine and diagnostic sciences UIC college of dentistry
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612-7213
Country
United States
Facility Name
Plus Clinic, University of Maryland Dental school
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Henry Ford Hospital and Wayne State University, Division of infectious diseases
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
AIDS Community Research Initiative of America
City
New-York
State/Province
New York
ZIP/Postal Code
10018
Country
United States
Facility Name
Department Diagnostics Sciences, UNC
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7450
Country
United States
Facility Name
East Carolina University, Brody School of Medicine
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27858
Country
United States
Facility Name
University of Oklahoma, College of medicine
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74129
Country
United States
Facility Name
Lehigh Valley Hospital Clinical Research Department of Medicine
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18102
Country
United States
Facility Name
Roger Williams Medical Center
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02908
Country
United States
Facility Name
Bering Omega Dental Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77006
Country
United States
Facility Name
Eastern Virginia Medical Center, Center for comprehensive care of immune deficiency
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Downtown Infectious Disease Clinic
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Providence Health Center British Columbia Centre for excellence in HIV/AIDS
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Health Sciences Center
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
GG441-820
Country
Canada
Facility Name
University of Ottawa Health Services
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
Montreal Chest Institutes immunodeficiency clinic
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2x2P4
Country
Canada
Facility Name
Montreal General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
12. IPD Sharing Statement
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Efficacy and Safety Study of Miconazole Lauriad to Treat Oropharyngeal Candidiasis in HIV Patients
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