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

Schering-Plough

Status and phase: Completed; Phase 3

Conditions: HIV Infections; Candidiasis, Oral

Treatments: Drug: Fluconazole; Drug: Posaconazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002446

I97-331

305A

C97-331

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.