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

Completed · Phase 3

Conditions studied: Candidiasis, Oral, HIV Infections

In brief

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.

Key facts

Study ID

NCT00002446

Run by

Schering-Plough

People needed

300

Starts

1998-08-01

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• You may be eligible for this study if you:
• Are at least 18 years old.
• Are HIV-positive.
• Have thrush (oropharyngeal candidiasis).
• Agree to practice sexual abstinence or use effective barrier methods of birth control (e.g., condoms).
• Are able to take study medication and return for clinic visits during the study.
• Are expected to live for at least 2 months.

You may not qualify if…

• You will not be eligible for this study if you:
• Have received protease inhibitors for the first time within 30 days prior to study entry.
• Have received certain medications.
• Have certain other types of fungal infections.
• Have certain types of cancer.
• Have received SCH 56592 within 3 months prior to study entry.
• Are pregnant or breast-feeding.
• Cannot take medications by mouth.
• Are allergic to azole drugs.
• Have certain medical conditions.
• Have been in this study before.

Where it is running

• 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 D.C., 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
• UMDNJ - New Jersey Med School / Cooper Hosp — Camden, New Jersey, United States
• Jersey City Med Ctr — Jersey City, New Jersey, United States
• SUNY / Health Science Ctr at Brooklyn — Brooklyn, New York, United States
• Univ of Pennsylvania School of Dental Medicine — Philadelphia, Pennsylvania, United States
• Med Univ of South Carolina — Charleston, South Carolina, United States
• Amelia Ct Clinic — Dallas, Texas, United States
• Univ of Texas Health Sciences Ctr — San Antonio, Texas, United States
• Queen Elizabeth Hosp Respiratory Unit — Saint Michael, Barbados

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.