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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Schering-Plough
• Treatments: Fluconazole; Posaconazole

Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.