Safety, Efficacy, and Pharmacokinetics of Amphotericin B Lipid Complex

This study has been completed.
Sponsor:
Collaborator:
Enzon Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Medstar Research Institute
ClinicalTrials.gov Identifier:
NCT01656382
First received: April 24, 2007
Last updated: August 2, 2012
Last verified: July 2012

April 24, 2007
August 2, 2012
January 2007
January 2010   (final data collection date for primary outcome measure)
  • Survival [ Designated as safety issue: No ]
  • Time to Sterilization of CSF [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01656382 on ClinicalTrials.gov Archive Site
Infusion related and renal toxicity [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Safety, Efficacy, and Pharmacokinetics of Amphotericin B Lipid Complex
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

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

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Invasive Cryptococcosis
Drug: ABLC
  • Active Comparator: 5 mg/kg/d ABLC x 14 days
    5 mg/kg/d of Amphotericin B Lipid Complex for 14 days
    Intervention: Drug: ABLC
  • Experimental: 10/kg/kg/d x 7 days
    10 mg/kg/d of Amphotericin B Lipid Complex for 7 days
    Intervention: Drug: ABLC
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
January 2010
January 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01656382
2006-273
No
Medstar Research Institute
Medstar Research Institute
Enzon Pharmaceuticals, Inc.
Principal Investigator: Shmuel Shoham, MD Washington Hospital Center
Medstar Research Institute
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP