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Sponsored by: |
Gilead Sciences |
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Information provided by: | Gilead Sciences |
ClinicalTrials.gov Identifier: | NCT00158730 |
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 |
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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 |
Estimated Enrollment: | 800 |
Study Start Date: | April 2003 |
Estimated Study Completion Date: | January 2005 |
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:
Ages Eligible for Study: | 1 Month and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | GS-131-101 |
Study First Received: | September 7, 2005 |
Last Updated: | November 17, 2005 |
ClinicalTrials.gov Identifier: | NCT00158730 |
Health Authority: | United States: Food and Drug Administration |
Abelcet Amphotericin B Mycoses Clotrimazole |
Miconazole Tioconazole Aspergillosis Liposomal amphotericin B |
Anti-Bacterial Agents Anti-Infective Agents Communicable Diseases Antiparasitic Agents Antiprotozoal Agents Antifungal Agents |
Therapeutic Uses Antibiotics, Antifungal Amebicides Infection Pharmacologic Actions |