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| 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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind 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 |
| 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:
Eligibility| Ages Eligible for Study: | 1 Month and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| ClinicalTrials.gov Identifier: | NCT00158730 History of Changes |
| Other Study ID Numbers: | GS-131-101 |
| Study First Received: | September 7, 2005 |
| Last Updated: | November 17, 2005 |
| Health Authority: | United States: Food and Drug Administration |
|
Aspergillosis Mycoses Amphotericin B Liposomal amphotericin B Amebicides Antiprotozoal Agents |
Antiparasitic Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antifungal Agents Anti-Bacterial Agents |