Safety, Efficacy, and Pharmacokinetics of Amphotericin B Lipid Complex

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01656382
Recruitment Status : Completed
First Posted : August 3, 2012
Last Update Posted : August 3, 2012
Enzon Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Medstar Health Research Institute

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.

Condition or disease Intervention/treatment Phase
Invasive Cryptococcosis Drug: ABLC Phase 4

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2007
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 5 mg/kg/d ABLC x 14 days
5 mg/kg/d of Amphotericin B Lipid Complex for 14 days
Drug: ABLC
Experimental: 10/kg/kg/d x 7 days
10 mg/kg/d of Amphotericin B Lipid Complex for 7 days
Drug: ABLC

Primary Outcome Measures :
  1. Survival
  2. Time to Sterilization of CSF

Secondary Outcome Measures :
  1. Infusion related and renal toxicity

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01656382

United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
Sponsors and Collaborators
Medstar Health Research Institute
Enzon Pharmaceuticals, Inc.
Principal Investigator: Shmuel Shoham, MD Washington Hospital Center

Responsible Party: Medstar Health Research Institute Identifier: NCT01656382     History of Changes
Other Study ID Numbers: 2006-273
First Posted: August 3, 2012    Key Record Dates
Last Update Posted: August 3, 2012
Last Verified: July 2012

Keywords provided by Medstar Health Research Institute:

Additional relevant MeSH terms:
Amphotericin B
Liposomal amphotericin B
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Anti-Bacterial Agents
Antifungal Agents