Clinical Trial: Safety, Efficacy, and Pharmacokinetics of Amphotericin B Lipid Complex
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Safety, Efficacy, and Pharmacokinetics of Amphotericin B Lipid Complex at 10 mg/kg/d for 7 Days or 5.0 mg/kg/d for 14 Days as Induction Therapy for Disseminated Cryptococcosis
Brief Summary: The purpose of this study is to determine if initial therapy with ABLC at 10/mg/kg/d for 7 days are at least effective as ABLC at 5.0 mg/kg/d X 14 days as induction treatment of patients with disseminated cryptococcosis and HIV.
Detailed Summary: This is a randomized, open label, prospective study of ABLC at 5.0 and 10.0 mg/kg/d for treatment of patients with cryptococcal meningitis. Patients will be randomly assigned in a 1:1 ratio to receive 5.0 or 10.0 mg/kg/d of ABLC as induction therapy for cryptococcal meningitis. Patients receiving 10 mg/kg/d doses will be treated with ABLC for 7 days whereas patients receiving ABLC at 5.0 mg/kg/d will receive 14 days of ABLC therapy. After completion of induction therapy subjects will receive long-term fluconazole maintenance therapy at the discretion of the treating physician. The study will be conducted at the Washington Hospital Center
Sponsor: Medstar Health Research Institute
Current Primary Outcome:
- Survival
- Time to Sterilization of CSF
Original Primary Outcome: Same as current
Current Secondary Outcome: Infusion related and renal toxicity
Original Secondary Outcome: Same as current
Information By: Medstar Health Research Institute
Dates:
Date Received: April 24, 2007
Date Started: January 2007
Date Completion:
Last Updated: August 2, 2012
Last Verified: July 2012
