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

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ClinicalTrials.gov Identifier: NCT00158730
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : November 18, 2005
Sponsor:
Information provided by:
Gilead Sciences

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 immunocompromised patients, as determined by overall response rates at end of course of treatment.

Condition or disease Intervention/treatment Phase
Invasive Aspergillosis Other Fungal Infections Drug: AmBisome Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : April 2003
Study Completion Date : January 2005





Primary Outcome Measures :
  1. Evaluate two regimens determined by overall response rates at end of tx.

Secondary Outcome Measures :
  1. 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


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Ages Eligible for Study:   1 Month and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Additional Information:
ClinicalTrials.gov Identifier: NCT00158730     History of Changes
Other Study ID Numbers: GS-131-101
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: November 18, 2005
Last Verified: September 2005

Additional relevant MeSH terms:
Infection
Mycoses
Aspergillosis
Hyalohyphomycosis
Dermatomycoses
Lung Diseases, Fungal
Skin Diseases, Infectious
Skin Diseases
Liposomal amphotericin B
Amphotericin B
Antifungal Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Amebicides
Anti-Bacterial Agents