Status:

COMPLETED

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

Lead Sponsor:

Valerio Therapeutics

Conditions:

HIV Infections

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief 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 th...

Eligibility Criteria

Inclusion

  • Patients with clinical picture of oropharyngeal candidiasis
  • Confirmation of oropharyngeal candidiasis by candida culture positive
  • HIV-positive patients
  • Patients 18 years of age

Exclusion

  • 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

Key Trial Info

Start Date :

July 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2008

Estimated Enrollment :

578 Patients enrolled

Trial Details

Trial ID

NCT00390780

Start Date

July 1 2006

End Date

January 1 2008

Last Update

September 16 2013

Active Locations (27)

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Page 1 of 7 (27 locations)

1

University of Alabama, Department of diagnostic Sciences School of Dentistry

Birmingham, Alabama, United States, 35294-00007

2

L.A. Gay & Lesbian center, Health & Mental, health services

Los Angeles, California, United States, 90028

3

East Bay AIDS Center

Oakland, California, United States, 94609

4

1401 Noth Palm Canyon

Palm Springs, California, United States, 92262