A Study to Compare the Use of Fluconazole as Continuous Therapy Versus Periodic Therapy in HIV-Positive Patients With Recurrent Thrush

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

This study will evaluate two different management strategies for patients with advanced HIV infection who are at risk for recurrent and fluconazole-refractory oropharyngeal candidiasis. The treatment duration will be at least 24 months in order to evaluate the long-term effects of the treatment strategies on the development of fluconazole-refractory thrush. In addition to investigating antifungal treatment as it relates to fluconazole-refractory infections, the study will evaluate host factors and organism-related factors in order to increase our understanding of the pathogenesis of orophar...

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Eligibility criteria

• • Inclusion Criteria
• You may be eligible for this study if you:
• • Are HIV-positive.
• • Have a CD4+ cell count less than 150 cells/mm3.
• • Had at least one episode of thrush in the 24 months before study entry.
• • Have a life expectancy of at least 12 months.
• • Weigh at least 88 pounds.
• • Are 13 years of age or older (consent of parent or guardian required if under 18).
• • Agree to practice abstinence or use effective methods of birth control during the study.
• • Exclusion Criteria
• You will not be eligible for this study if you:
• • Have an allergy to azoles.
• • Have had 3 episodes or more of thrush within 12 weeks of study entry.
• • Have a history of esophageal candidiasis.
• • Have a history of fluconazole-resistant infection.
• • Have an active opportunistic infection requiring treatment within 14 days before study entry.
• • Have a fungal infection requiring certain medications.
• • Have a severe liver disease (e.g., cirrhosis).
• • Are unable to tolerate oral medications.
• • Take certain medications.
• • Are pregnant or breast-feeding.

Trial Officials