Safety and Effectiveness of Fluconazole Versus SCH 56592 to Treat Thrush in HIV-Positive Patients

Phase 3

Completed

• Conditions: Candidiasis, Oral; HIV Infections

• Registration Number: NCT00002446
• Lead Sponsor: Schering-Plough

Brief Summary

The purpose of this study is to compare the safety and effectiveness of 2 treatments for thrush (a fungal infection of the mouth and throat) in HIV-positive patients. Fluconazole is a drug that is commonly used to treat thrush. SCH 56592 is a new drug that will be compared to fluconazole.

Detailed Description

Patients receive SCH 56592 oral suspension or fluconazole suspension for 14 days. Patients remain on study for 44 days total and are monitored for safety and efficacy of study treatment.

Study Timeline

• Study Start: 1998-08
• Study First Submitted: 1999-11-02
• Status Verified: 2000-02
• 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: 300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (18)

East Bay AIDS Ctr; 🇺🇸 Berkeley, California, United States

ViRx Inc; 🇺🇸 San Francisco, California, United States

Kaiser Foundation Hospital; 🇺🇸 San Francisco, California, United States

Infectious Disease and AIDS Clinic; 🇺🇸 Denver, Colorado, United States

Dupont Circle Physicians Group; 🇺🇸 Washington, District of Columbia, United States

Boulevard Comprehensive Care Ctr; 🇺🇸 Jacksonville, Florida, United States

Miami Veterans Administration Med Ctr; 🇺🇸 Miami, Florida, United States

TRIAD Health Practice; 🇺🇸 Chicago, Illinois, United States

Community Hosp Indianapolis; 🇺🇸 Indianapolis, Indiana, United States

Wayne State Univ / Harper Hosp; 🇺🇸 Detroit, Michigan, United States

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