Safety and Effectiveness of Giving L-743,872 to Patients With Thrush That Has Not Been Cured With Fluconazole

Candidiasis, Oral, HIV Infections

AIDS-Related Opportunistic Infections, Dose-Response Relationship, Drug, Fluconazole, Antifungal Agents, Candidiasis, Oral, Pharyngeal Diseases, MK 0991

The purpose of this study is to see if it is safe and effective to give L-743,872 to patients with thrush, an AIDS-related yeast infection of the mouth, that has not been cured with fluconazole treatment.

Patients are randomized to treatment with L-743,872 at one of two doses administered intravenously by a peripheral line once-daily. Patients are treated for 48 hours beyond resolution of symptoms or for a maximum of 14 days. Each patient is expected to complete the study, including the 14-day follow-up, within approximately 4 weeks. A physical examination is performed daily during the antifungal treatment period and at the follow-up visits 7 and 14 days post-therapy. Laboratory tests of blood and urine for safety are performed every three days during treatment and at follow-up 7 days post-therapy. Liver enzymes are drawn at the 14-day follow-up visit.

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United States