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

Condition(s) targeted: HIV Infections

Intervention: miconazole Lauriad (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: BioAlliance Pharma SA

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).

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 design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

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 19) using the scoring scale of Murray

Secondary outcome:

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

University of Alabama, Department of diagnostic Sciences School of Dentistry, Birmingham, Alabama 35294-00007, United States

Providence Health Center British Columbia Centre for excellence in HIV/AIDS, Vancouver, British Columbia, Canada

Downtown Infectious Disease Clinic, Vancouver, British Columbia, Canada

East Bay AIDS Center, Oakland, California 94609, United States

L.A. Gay & Lesbian center, Health & Mental, health services, Los Angeles, California 90028, United States

1401 Noth Palm Canyon, Palm Springs, California 92262, United States

University of Connecticut, School of dental medicine, Farmington, Connecticut 06030, United States

Therafirst Medical Center, Fort Lauderdale, Florida 33308, United States

University of Miami, Miami, Florida 33136, United States

Ryan White Title III Clinic, Labelle, Florida 33935, United States

Triple O Medical Services, West Palm Beach, Florida 21201, United States

Fort Lauderdale, Florida, United States

Department of oral medicine and diagnostic sciences UIC college of dentistry, Chicago, Illinois 60612-7213, United States

Health Sciences Center, Winnipeg, Manitoba GG441-820, Canada

Plus Clinic, University of Maryland Dental school, Baltimore, Maryland 21201, United States

Henry Ford Hospital and Wayne State University, Division of infectious diseases, Detroit, Michigan 48202, United States

AIDS Community Research Initiative of America, New-York, New York 10018, United States

East Carolina University, Brody School of Medicine, Greenville, North Carolina 27858, United States

Department Diagnostics Sciences, UNC, Chapel Hill, North Carolina 27599-7450, United States

University of Oklahoma, College of medicine, Tulsa, Oklahoma 74129, United States

University of Ottawa Health Services, Ottawa, Ontario, Canada

Lehigh Valley Hospital Clinical Research Department of Medicine, Allentown, Pennsylvania 18102, United States

Montreal Chest Institutes immunodeficiency clinic, Montreal, Quebec H2x2P4, Canada

Montreal General Hospital, Montreal, Quebec H3G 1A4, Canada

Roger Williams Medical Center, Providence, Rhode Island 02908, United States

Bering Omega Dental Clinic, Houston, Texas 77006, United States

Eastern Virginia Medical Center, Center for comprehensive care of immune deficiency, Norfolk, Virginia 23507, United States

Starting date: July 2006
Ending date: November 2007
Last updated: December 5, 2007