CompletedPhase 3

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

United States578 participantsStarted 2006-07

Plain-language 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).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Trial details

NCT IDNCT00390780

SponsorValerio Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2007-12

Results submitted2012-09-07

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