Safety, Efficacy, and Pharmacokinetics of Amphotericin B Lipid Complex

Invasive Cryptococcosis Clinical Trial

Official title:

Safety, Efficacy, and Pharmacokinetics of Amphotericin B Lipid Complex at 10 mg/kg/d for 7 Days or 5.0 mg/kg/d for 14 Days as Induction Therapy for Disseminated Cryptococcosis in Patients With HIV

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01656382
• Other study ID #: 2006-273
• Status: Withdrawn
• Phase: Phase 4
• Start date: January 2007
• Est. completion date: January 2010

Study information

• Verified date: February 2021
• Source: Medstar Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cryptococcosis
• Invasive Cryptococcosis

Intervention

Drug:
• ABLC

Locations

Country	Name	City	State
United States	Washington Hospital Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Medstar Health Research Institute	Enzon Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival
Primary	Time to Sterilization of CSF
Secondary	Infusion related and renal toxicity