Status:
COMPLETED
Study Safety/Efficacy of AmBisome Loading Dose Regimen Versus Standard AmBisome Regimen for Initial Treatment
Lead Sponsor:
Gilead Sciences
Conditions:
Invasive Aspergillosis
Other Fungal Infections
Eligibility:
All Genders
1+ years
Phase:
PHASE3
Brief 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 immunocompromis...
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 immunocompromis...
Eligibility Criteria
Inclusion
- Immunocompromised due to hematologic malignancies, chemotherapy-induced neutropenia, hematopoietic stem cell transplantation, solid organ transplantation, other conditions resulting in severe neutropenia, HIV infection, prolonged corticosteroid therapy (greater than or less than 20 mg of Prednisone or equivalent for greater than or less than 3 weeks), treatment with other immunosuppressant medications, or other acquired or hereditary immunocompromising conditions that place the patients at risk for IFI. Evidence of Proven, Probably or Possible IFFI by modified EORTC criteria. Continued treatment with study drug is contingent upon confirmation of diagnosis of Proven or Probable IFI within 4 working days after study entry.
Exclusion
- Life expectancy of less than 30 days; chronic IFI (defined as signs/symptoms of IFI present for less 4 weeks preceding entry into study;prior systemic therapy of greater than or less than 4 days with any polyene anti-fungal agent within 14 days of study enrollment;prior systemic therapy of greater than or less than 4 days with non-polyenes for the current, documented IFI. Use of another investigational, unlicensed drug within 30 days of screening or concurrent participation in another clinical trial using an investigational, unlicensed drug; serum creatinine greater than 2 x upper limit of normal (ULN), serum ALT or AST less than 5 x ULN; pregnant or lactating women; history of allergy or serious adverse reaction to any polyene anti-fungal agent.
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
End Date :
January 1 2005
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT00158730
Start Date
April 1 2003
End Date
January 1 2005
Last Update
November 18 2005
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