Safety, Efficacy, and Pharmacokinetics of Amphotericin B Lipid Complex

• Status: Withdrawn
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medstar Health Research Institute
• Collaborator: Enzon Pharmaceuticals, Inc.
• Treatments: Amphotericin B; Liposomal amphotericin B

Criteria

Inclusion Criteria:

1. Diagnosis of cryptococcal meningitis based on any of the following:

• Cerebrospinal fluid positive for C. neoformans

• Cerebrospinal fluid positive for cryptococcal antigen

2. Male or female 18 years of age or older.

3. 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.

4. 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:

1. A history or evidence of hypersensitivity to AmB or any of its metabolites.

2. 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.

3. Inability to comply with the procedures of the study.

4. Patients who have received greater than 72 hours of therapy with another systemic antifungal agent within 2 weeks prior to enrollment

5. Patients with any of the following abnormal laboratory values

• Baseline creatinine clearance of less than 50.

• Bilirubin of greater than 5 times the upper limit of normal

• AST or ALT of greater than 10 times the upper limit of normal

6. Life expectancy of less than 72 hours