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

• Status: Completed
• Trial end date: 2002-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether it is better to treat patients with fluconazole on a continuous basis to prevent thrush (yeast infection in the mouth) from coming back or to wait and treat each episode of thrush.

Fluconazole is one of the most commonly prescribed drugs to treat thrush and other yeast infections. However, the number of patients with fluconazole-resistant thrush is increasing, and it is not known whether continuous or intermittent use of fluconazole leads to greater resistance. Therefore, it is important to determine the most effective treatment strategy.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Washington University School of Medicine
• Treatments: Fluconazole

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.