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

Valerio Therapeutics

Status and phase: Completed; Phase 3

Conditions: HIV Infections

Treatments: Drug: Clotrimazole; Drug: miconazole Lauriad

Study type: Interventional

Funder types: Industry

Identifiers

NCT00390780

BA/2004/01/04

Details and patient eligibility

About

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).

Enrollment: 578 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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578 participants in 2 patient groups

Clotrimazole

Active Comparator group

Description:

Clotrimazole troches, 10 mg, 5 times per day for 14 days

Treatment:

Drug: Clotrimazole

miconazole Lauriad

Experimental group

Description:

Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days

Treatment:

Drug: miconazole Lauriad