Study Safety/Efficacy of AmBisome Loading Dose Regimen Versus Standard AmBisome Regimen for Initial Treatment
Information source: Gilead Sciences
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Invasive Aspergillosis; Other Fungal Infections
Intervention: AmBisome (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Gilead Sciences
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 Details
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
Study design: Treatment, Randomized, Double-Blind, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Evaluate two regimens determined by overall response rates at end of tx.
Secondary outcome: Compare Safety/tolerability; survival rates/rates of infection relapse at 4 wks post tx; survival rate at 12 wks after study entry; TOVR; time to end of tx for patients w/favorable overall response;cumulative dose
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.
Eligibility
Minimum age: 1 Month.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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.
Locations and Contacts
Additional Information
Website for AmBisome Website for Gilead
Starting date: April 2003
Ending date: January 2005
Last updated: November 17, 2005
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