Official Title: “Randomized, Controlled Trial of SCH 56592 Oral Suspension Versus Fluconazole Suspension in the Treatment of Oropharyngeal Candidiasis (OPC) in HIV-Positive Patients”

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.

Study Type: Interventional

Study Design: Treatment, Double-Blind, Safety Study

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.

Intervention(s) in this Clinical Trial

• Drug: Posaconazole
• Drug: Fluconazole

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Schering-Plough

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00002446

Study ID Number: 305A

ClinicalTrials.gov Identifier: NCT00002446

Health Authority: United States: Food and Drug Administration