Phase 3 N=578 Randomized Quadruple-blind Treatment

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

HIV Infections

Bottom Line

View on ClinicalTrials.gov: NCT00390780 ↗

Enrolled (actual)

578

Serious AEs

3.3%

Results posted

Aug 2013

Primary outcome: Primary: 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 — 176; 187; 114; 100 participants — p=>0.025

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: miconazole Lauriad (Drug); Clotrimazole (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Valerio Therapeutics
Primary completion: Dec 2007

Outcome Measures

Outcome	Result	p-value
PRIMARY 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	176; 187; 114; 100; 164; 175	>0.025
SECONDARY Clinical Cure at Day 7 (Using Murray Scoring Scale)	67; 71; 210; 202; 13; 14	>0.025
SECONDARY Clinical Success at Test-of-cure Visit (Day 17-22) (Using Murray Scoring Scale)	188; 199; 80; 61; 22; 27	0.0974
SECONDARY Clinical Success at Day 7 (Using Murray Scoring Scale)	92; 89; 185; 184; 13; 14	0.8787
SECONDARY Partial Response at Test of Cure Visit (Days 17-22) Using Murray Scoring Scale	139; 140; 120; 123	0.8820
SECONDARY Mycological Cure at the Test of Cure Visit (Day 17-22)	79; 71; 185; 185; 26; 31	0.5816
SECONDARY Relapse at the Late Post-Therapy Visit (Day 35-38)	183; 197; 51; 53; 132; 144	0.8330
SECONDARY Oral Discomfort Using Visual Analog Scale (VAS)	0.8; 0.4	—
SECONDARY General and Local Tolerability and Oral Discomfort	34; 26; 235; 233; 21; 28	—
SECONDARY Duration of Adhesion of Miconazole Lauriad 50 mg Mucoadhesive Buccal Tablet	13; 13	—
SECONDARY Systemic Exposure of Miconazole Lauriad 50 mg Bioadhesive Buccal Tablet	0; 0	—
SECONDARY Susceptibility of Candida Species by Microdilution Test	0.0099; 0.0073; 0.0764; 0.1664	0.1860
SECONDARY Treatment Compliance	253; 250	—

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).

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00390780). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.