HIV InfectionsPhase 3NCT00390780
Efficacy and Safety Study of Miconazole Lauriad to Treat Oropharyngeal Candidiasis in HIV Patients
A Phase 3 study testing miconazole Lauriad and Clotrimazole in people with HIV Infections, run by Valerio Therapeutics at 27 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- miconazole Lauriad and Clotrimazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 578 participants
- Where
- 27 sitesin 2 countries
- Study dates
- Jul 2006to Jan 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with clinical picture of oropharyngeal candidiasis
- Confirmation of oropharyngeal candidiasis by candida culture positive
- HIV-positive patients
- Patients 18 years of age
Who cannot join
- 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
Trial locations and contacts
27 sites in 2 countries.
27 sites in 2 countries
United States21 sites
Lehigh Valley Hospital Clinical Research Department of Medicine
Allentown, Pennsylvania, 18102
Plus Clinic, University of Maryland Dental school
Baltimore, Maryland, 21201
University of Alabama, Department of diagnostic Sciences School of Dentistry
Birmingham, Alabama, 35294-00007
Department Diagnostics Sciences, UNC
Chapel Hill, North Carolina, 27599-7450
Department of oral medicine and diagnostic sciences UIC college of dentistry
Chicago, Illinois, 60612-7213
Henry Ford Hospital and Wayne State University, Division of infectious diseases
Detroit, Michigan, 48202
University of Connecticut, School of dental medicine
Farmington, Connecticut, 06030
Therafirst Medical Center
Fort Lauderdale, Florida, 33308
Study site
Fort Lauderdale, Florida
East Carolina University, Brody School of Medicine
Greenville, North Carolina, 27858
Bering Omega Dental Clinic
Houston, Texas, 77006
Ryan White Title III Clinic
LaBelle, Florida, 33935
L.A. Gay & Lesbian center, Health & Mental, health services
Los Angeles, California, 90028
University of Miami
Miami, Florida, 33136
AIDS Community Research Initiative of America
New York, New York, 10018
Eastern Virginia Medical Center, Center for comprehensive care of immune deficiency
Norfolk, Virginia, 23507
East Bay AIDS Center
Oakland, California, 94609
1401 Noth Palm Canyon
Palm Springs, California, 92262
Roger Williams Medical Center
Providence, Rhode Island, 02908
University of Oklahoma, College of medicine
Tulsa, Oklahoma, 74129
Triple O Medical Services
West Palm Beach, Florida, 21201
Canada6 sites
Montreal Chest Institutes immunodeficiency clinic
Montreal, Quebec, H2x2P4
Montreal General Hospital
Montreal, Quebec, H3G 1A4
University of Ottawa Health Services
Ottawa, Ontario
Downtown Infectious Disease Clinic
Vancouver, British Columbia
Providence Health Center British Columbia Centre for excellence in HIV/AIDS
Vancouver, British Columbia
Health Sciences Center
Winnipeg, Manitoba, GG441-820
About this study
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
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).
- Conditions
- HIV Infections
- Being tested
- miconazole Lauriad, Clotrimazole
- Keywords
- Miconazole Lauriad, Oropharyngeal candidiasis, HIV patients, Mycology, Clinical picture of Oropharyngeal candidiasis, Candida culture positive, Treatment Experienced
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
miconazole LauriadDrug
50 mg buccal tablet once a day for 14 days
ClotrimazoleDrug
10mg troches administered Five Times a Day for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Clotrimazole | Active comparator | Clotrimazole troches, 10 mg, 5 times per day for 14 days Receives: Drug: Clotrimazole |
| miconazole Lauriad | Experimental | Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days Receives: Drug: miconazole Lauriad |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 17 to 22 days
Secondary outcomes (12)
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.
Measured: 7 days
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.
Measured: 17 to 22 days
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.
Measured: 7 days
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
Measured: 17 to 22 days
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.
Measured: 17 to 22 days
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".
Measured: 35 to 38 days
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)
Measured: 14 days
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.
Measured: 14 days
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
Measured: 14 days
Systemic Exposure of Miconazole Lauriad 50 mg Bioadhesive Buccal Tablet
Number of patients with detectable plasma concentration at Visit 3 (day 7)
Measured: 7 days
Susceptibility of Candida Species by Microdilution Test
minimum inhibitory concentration (MIC) in nonresponders at test-of-cure visit
Measured: Initiation of treatment to Day 17 to 22
Treatment Compliance
Number of patients who were 100% compliant with the treatment regimen
Measured: Initiation of treatment to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2006 (estimated)
- Study startJul 2006
- Primary completionDec 2007
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 578 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valerio Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00390780
- Sponsor's protocol ID
- BA/2004/01/04
- Status last verified
- Feb 2013
- First submitted
- 19 Oct 2006
- Last updated
- 16 Sep 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00390780
- Acronym / sponsor ID
- BA/2004/01/04
- Conditions
- HIV Infections
- Keywords
- Miconazole Lauriad, Oropharyngeal candidiasis, HIV patients, Mycology, Clinical picture of Oropharyngeal candidiasis, Candida culture positive, Treatment Experienced
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 578 participants (actual)
- Lead sponsor
- Valerio TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 20 Oct 2006 (estimated)
- Results
- Posted 29 Aug 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clotrimazole | Active comparator | Drug: ClotrimazoleClotrimazole troches, 10 mg, 5 times per day for 14 days |
| miconazole Lauriad | Experimental | Drug: miconazole LauriadMiconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with clinical picture of oropharyngeal candidiasis
- Confirmation of oropharyngeal candidiasis by candida culture positive
- HIV-positive patients
- Patients 18 years of age
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| miconazole Lauriad50 mg buccal tablet once a day for 14 days | Drug | miconazole Lauriad |
| Clotrimazole10mg troches administered Five Times a Day for 14 days | Drug | Clotrimazole |
Primary outcome
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
Time frame: 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.
12 secondary outcomes
Clinical Cure at Day 7 (Using Murray Scoring Scale)
Time frame: 7 days
Clinical Success at Test-of-cure Visit (Day 17-22) (Using Murray Scoring Scale)
Time frame: 17 to 22 days
Clinical Success at Day 7 (Using Murray Scoring Scale)
Time frame: 7 days
Partial Response at Test of Cure Visit (Days 17-22) Using Murray Scoring Scale
Time frame: 17 to 22 days
Mycological Cure at the Test of Cure Visit (Day 17-22)
Time frame: 17 to 22 days
Relapse at the Late Post-Therapy Visit (Day 35-38)
Time frame: 35 to 38 days
Oral Discomfort Using Visual Analog Scale (VAS)
Time frame: 14 days
General and Local Tolerability and Oral Discomfort
Time frame: 14 days
Duration of Adhesion of Miconazole Lauriad 50 mg Mucoadhesive Buccal Tablet
Time frame: 14 days
Systemic Exposure of Miconazole Lauriad 50 mg Bioadhesive Buccal Tablet
Time frame: 7 days
Susceptibility of Candida Species by Microdilution Test
Time frame: Initiation of treatment to Day 17 to 22
Treatment Compliance
Time frame: Initiation of treatment to Day 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
27 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing miconazole Lauriad and Clotrimazole in people with HIV Infections, run by Valerio Therapeutics at 27 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 17 to 22 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2013.