Clinical Trial: A Study of Amphotericin B in the Treatment of Fungal Infections of the Mouth in HIV-Infected Patients Who Have Not Had Success With Fluconazole
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase II Trial of Amphotericin B Oral Suspension for Fluconazole-Resistant Oral Candidiasis in HIV-Infected Patients
Brief Summary:
To assess response and toxicity in patients with fluconazole-resistant oral candidiasis ( thrush ) when given initial induction with amphotericin B oral suspension.
Experience with amphotericin B oral suspension for drug-sensitive thrush in HIV-infected patients is limited but encouraging.
Detailed Summary:
Experience with amphotericin B oral suspension for drug-sensitive thrush in HIV-infected patients is limited but encouraging.
Patients swish and swallow amphotericin B oral suspension after each meal and at bedtime for 14 days, at which time they are deemed a responder, nonresponder, or failure to induction therapy. Responders receive maintenance twice daily, while nonresponders receive 14 further days of initial induction. Failures discontinue the study. Responders after 28 days of induction are placed on maintenance. After successful completion of initial induction, patients remain on study for 6 months.
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Current Primary Outcome:
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: National Institute of Allergy and Infectious Diseases (NIAID)
Dates:
Date Received: November 2, 1999
Date Started:
Date Completion:
Last Updated: May 1, 2012
Last Verified: May 2012
