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Efficacy and Safety Study of Miconazole Lauriad to Treat Oropharyngeal Candidiasis in HIV Patients

This study has been completed.
Sponsor:
Information provided by:
BioAlliance Pharma SA
ClinicalTrials.gov Identifier:
NCT00390780
First received: October 19, 2006
Last updated: January 9, 2009
Last verified: January 2009
History of Changes
  Purpose

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).


Condition Intervention Phase
HIV Infections
 Drug: miconazole Lauriad
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by BioAlliance Pharma SA:

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 19) using the scoring scale of Murray

Secondary Outcome Measures:
  • Clinical cure at Day 7
  • Clinical success rates at Day 7 and at the Test of Cure visit (Day 17-19)
  • Microbiological cure at the Test of Cure visit (Day 17-19)
  • Rate of relapse at Day 35-38
  • General and local tolerability and oral discomfort
  • Duration of adhesion of miconazole Lauriad 50 mg bioadhesive buccal tablet
  • Systemic exposure of miconazole Lauriad 50 mg bioadhesive buccal tablet
  • Susceptibility of Candida species by microdilution test
  • Compliance

Enrollment: 578
Study Start Date: July 2006
Study Completion Date: January 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00390780

  Show 27 Study Locations
Sponsors and Collaborators
BioAlliance Pharma SA
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00390780     History of Changes
Other Study ID Numbers: BA/2004/01/04
Study First Received: October 19, 2006
Last Updated: January 9, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by BioAlliance Pharma SA:
Miconazole Lauriad
Oropharyngeal candidiasis
HIV patients
Mycology
 Clinical picture of Oropharyngeal candidiasis
Candida culture positive
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Candidiasis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
 Mycoses
Miconazole
Clotrimazole
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Local

ClinicalTrials.gov processed this record on March 10, 2013