Safety, Efficacy, and Pharmacokinetics of Amphotericin B Lipid Complex

NCT ID: NCT01656382

Last Updated: 2021-02-17

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2010-01-31

Brief 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.

Detailed Description

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

Conditions

Invasive Cryptococcosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

5 mg/kg/d ABLC x 14 days

5 mg/kg/d of Amphotericin B Lipid Complex for 14 days

Group Type: ACTIVE_COMPARATOR

ABLC

Intervention Type: DRUG

10/kg/kg/d x 7 days

10 mg/kg/d of Amphotericin B Lipid Complex for 7 days

Group Type: EXPERIMENTAL

ABLC

Intervention Type: DRUG

Interventions

ABLC

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Enzon Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: collaborator

Medstar Health Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shmuel Shoham, MD

Role: PRINCIPAL_INVESTIGATOR

Medstar Health Research Institute

Locations

Washington Hospital Center

Washington D.C., District of Columbia, United States

Countries

United States

Other Identifiers

2006-273

Identifier Type: -

Identifier Source: org_study_id