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| Name | Class |
|---|---|
| Enzon Pharmaceuticals, Inc. | INDUSTRY |
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The purpose of this study is to determine if initial therapy with ABLC at 10/mg/kg/d for 7 days are at least effective as ABLC at 5.0 mg/kg/d X 14 days as induction treatment of patients with disseminated cryptococcosis and HIV.
This is a randomized, open label, prospective study of ABLC at 5.0 and 10.0 mg/kg/d for treatment of patients with cryptococcal meningitis. Patients will be randomly assigned in a 1:1 ratio to receive 5.0 or 10.0 mg/kg/d of ABLC as induction therapy for cryptococcal meningitis. Patients receiving 10 mg/kg/d doses will be treated with ABLC for 7 days whereas patients receiving ABLC at 5.0 mg/kg/d will receive 14 days of ABLC therapy. After completion of induction therapy subjects will receive long-term fluconazole maintenance therapy at the discretion of the treating physician. The study will be conducted at the Washington Hospital Center
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5 mg/kg/d ABLC x 14 days | Active Comparator | 5 mg/kg/d of Amphotericin B Lipid Complex for 14 days |
|
| 10/kg/kg/d x 7 days | Experimental | 10 mg/kg/d of Amphotericin B Lipid Complex for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABLC | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Survival | ||
| Time to Sterilization of CSF |
| Measure | Description | Time Frame |
|---|---|---|
| Infusion related and renal toxicity |
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Inclusion Criteria:
Diagnosis of cryptococcal meningitis based on any of the following:
Male or female 18 years of age or older.
All female patients must be non-lactating and have a negative serum pregnancy test at time of screening. Females of childbearing potential must be using a medically acceptable method of contraception and agree to continue its use during the study period, or must be one year postmenopausal, or have been surgically sterilized.
Willing and able to give a signed informed consent, or have a legally authorized representative who is willing or able to give consent
Exclusion Criteria:
A history or evidence of hypersensitivity to AmB or any of its metabolites.
A history or evidence of any psychiatric, neurological metabolic, or other chronic condition, which in the investigator's opinion, would make the patient unsuitable for the study or interfere with the evaluation of ABLC.
Inability to comply with the procedures of the study.
Patients who have received greater than 72 hours of therapy with another systemic antifungal agent within 2 weeks prior to enrollment
Patients with any of the following abnormal laboratory values
Life expectancy of less than 72 hours
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| Name | Affiliation | Role |
|---|---|---|
| Shmuel Shoham, MD | Medstar Health Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
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| ID | Term |
|---|---|
| D003453 | Cryptococcosis |
| ID | Term |
|---|---|
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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