Back to resultsSafety, Efficacy, and Pharmacokinetics of Amphotericin B Lipid Complex
Primary Purpose
Invasive Cryptococcosis
Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
ABLC
Sponsored by
About this trial
This is an interventional treatment trial for Invasive Cryptococcosis focused on measuring ABLC, cryptococcosis
Eligibility Criteria
Inclusion Criteria:
Diagnosis of cryptococcal meningitis based on any of the following:
- Cerebrospinal fluid positive for C. neoformans
- Cerebrospinal fluid positive for cryptococcal antigen
- 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
- 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
- Life expectancy of less than 72 hours
Sites / Locations
- Washington Hospital Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
5 mg/kg/d ABLC x 14 days
10/kg/kg/d x 7 days
Arm Description
5 mg/kg/d of Amphotericin B Lipid Complex for 14 days
10 mg/kg/d of Amphotericin B Lipid Complex for 7 days
Outcomes
Primary Outcome Measures
Survival
Time to Sterilization of CSF
Secondary Outcome Measures
Infusion related and renal toxicity
Full Information
NCT ID
NCT01656382
First Posted
April 24, 2007
Last Updated
February 15, 2021
Sponsor
Medstar Health Research Institute
Collaborators
Enzon Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01656382
Brief Title
Safety, Efficacy, and Pharmacokinetics of Amphotericin B Lipid Complex
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Withdrawn
Study Start Date
January 2007 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medstar Health Research Institute
Collaborators
Enzon Pharmaceuticals, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Invasive Cryptococcosis
Keywords
ABLC, cryptococcosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
5 mg/kg/d ABLC x 14 days
Arm Type
Active Comparator
Arm Description
5 mg/kg/d of Amphotericin B Lipid Complex for 14 days
Arm Title
10/kg/kg/d x 7 days
Arm Type
Experimental
Arm Description
10 mg/kg/d of Amphotericin B Lipid Complex for 7 days
Intervention Type
Drug
Intervention Name(s)
ABLC
Primary Outcome Measure Information:
Title
Survival
Title
Time to Sterilization of CSF
Secondary Outcome Measure Information:
Title
Infusion related and renal toxicity
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of cryptococcal meningitis based on any of the following:
Cerebrospinal fluid positive for C. neoformans
Cerebrospinal fluid positive for cryptococcal antigen
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
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
Life expectancy of less than 72 hours
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shmuel Shoham, MD
Organizational Affiliation
Medstar Health Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety, Efficacy, and Pharmacokinetics of Amphotericin B Lipid Complex
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