Candidiasis, Oral, HIV Infections
Conditions
Keywords
AIDS-Related Opportunistic Infections, Fluconazole, Administration, Oral, Antifungal Agents, Candidiasis, Oral, Pharyngeal Diseases, posaconazole
Brief 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.
Detailed 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.
Interventions
DRUGPosaconazole
DRUGFluconazole
Sponsors
Schering-Plough
Study design
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Countries
Barbados, United States
Outcome results
None listed