Study Safety/Efficacy of AmBisome Loading Dose Regimen Versus Standard AmBisome Regimen for Initial Treatment

Invasive Aspergillosis Clinical Trial

Official title: Study of the Safety and Efficacy of AmBisome Loading Dose Regimen Vs. a Standard AmBisome Regimen for Initial Treatment of Invasive Aspergillosis and Other Filamentous Fungal Infections in Immunocompromised Patients

Status Completed

Clinical Trial Summary

To evaluate and compare two AmBisome dosing regimens for the initial treatment of invasive aspergillosis and other filamentous fungal infections diagnosed by modified EORTC criteria in immunocompromised patients, as determined by overall response rates at end of course of treatment.

Clinical Trial Description

To evaluate and compare two AmBisome dosing regimens for the initial treatment of invasive aspergillosis and other filamentous fungal infections diagnosed by modified EORTC criteria in immunocompromised patients, as determined by overall response rates at end of course of treatment.

Determine and compare the following parameters for the two treatment arms:

• Safety and tolerability

• Survival rates and the rates of infection relapse at 4 weeks Post Treatment.

• Survival rate at 12 weeks after study entry.

• Time to favorable overall response and time to End of Treatment for patients with favorable overall response.

• Cumulative dose of study drug given through End of Treatment. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aspergillosis
• Invasive Aspergillosis
• Mycoses
• Other Fungal Infections

• NCT number: NCT00158730
• Study type: Interventional
• Source: Gilead Sciences
• Status: Completed
• Phase: Phase 3
• Start date: April 2003
• Completion date: January 2005