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Study Safety/Efficacy of AmBisome Loading Dose Regimen Versus Standard AmBisome Regimen for Initial Treatment
This study has been completed.
First Received: September 7, 2005   Last Updated: November 17, 2005   History of Changes
Sponsor: Gilead Sciences
Information provided by: Gilead Sciences
ClinicalTrials.gov Identifier: NCT00158730
  Purpose

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 Intervention Phase
Invasive Aspergillosis
Other Fungal Infections
Drug: AmBisome
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 800
Study Start Date: April 2003
Estimated Study Completion Date: January 2005
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

Ages Eligible for Study:   1 Month and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Additional Information:
No publications provided

Study ID Numbers: GS-131-101
Study First Received: September 7, 2005
Last Updated: November 17, 2005
ClinicalTrials.gov Identifier: NCT00158730     History of Changes
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Abelcet
Communicable Diseases
Amphotericin B
Anti-Infective Agents
Antiprotozoal Agents
Aspergillosis
Infection
Liposomal amphotericin B
Pharmacologic Actions
Anti-Bacterial Agents
Mycoses
Antiparasitic Agents
Antifungal Agents
Therapeutic Uses
Antibiotics, Antifungal
Amebicides

ClinicalTrials.gov processed this record on February 08, 2010