Trials / Completed
CompletedNCT00158730
Study Safety/Efficacy of AmBisome Loading Dose Regimen Versus Standard AmBisome Regimen for Initial Treatment
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
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 800 (planned)
- Sponsor
- Gilead Sciences · Industry
- Sex
- All
- Age
- 1 Month
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AmBisome |
Timeline
- Start date
- 2003-04-01
- Completion
- 2005-01-01
- First posted
- 2005-09-12
- Last updated
- 2005-11-18
Source: ClinicalTrials.gov record NCT00158730. Inclusion in this directory is not an endorsement.