Comparative Randomized Study of the Efficacy, Safety, and Toleration of Fluconazole Oral Suspension or Nystatin Oral Suspension in the Treatment of Patients With Oropharyngeal Candidiasis in Association With the Acquired Immunodeficiency Syndrome

Not Applicable

Completed

• Conditions: Candidiasis, Oral; HIV Infections

• Registration Number: NCT00002112
• Lead Sponsor: Pfizer

Brief Summary

To compare the efficacy, safety, and toleration of fluconazole as a single daily oral suspension for 14 days versus nystatin oral suspension 4 times daily for 14 days in the treatment of oropharyngeal candidiasis in patients with AIDS or HIV infection.

Detailed Description

Patients are randomized to receive fluconazole oral suspension once daily (swallowed at approximately the same time every day) for 14 days or nystatin oral suspension used to rinse the mouth four times daily for 14 days. No food or drink is permitted immediately following the administration of the nystatin.

Study Timeline

• Status Verified: 1996-04
• Study First Submitted: 1999-11-02
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Last Update Submitted: 2005-06-23
• Last Update Posted: 2005-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (5)

California Med Research Group; 🇺🇸 Fresno, California, United States

UCSF Hosp; 🇺🇸 San Francisco, California, United States

Johns Hopkins School of Medicine; 🇺🇸 Baltimore, Maryland, United States

Med College of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Hampton Roads Med Specialists; 🇺🇸 Hampton, Virginia, United States