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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (18)

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

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

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

Med Univ of South Carolina; 🇺🇸 Charleston, South Carolina, United States

Univ of Texas Health Sciences Ctr; 🇺🇸 San Antonio, Texas, United States

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

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

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

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

SUNY / Health Science Ctr at Brooklyn; 🇺🇸 Brooklyn, New York, United States

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

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

Queen Elizabeth Hosp Respiratory Unit; 🇧🇧 St Michael, Barbados

Jersey City Med Ctr; 🇺🇸 Jersey City, New Jersey, United States

Amelia Ct Clinic; 🇺🇸 Dallas, Texas, United States

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

Univ of Pennsylvania School of Dental Medicine; 🇺🇸 Philadelphia, Pennsylvania, United States

UMDNJ - New Jersey Med School / Cooper Hosp; 🇺🇸 Camden, New Jersey, United States