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
  Purpose

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 Intervention Phase
Invasive Cryptococcosis
Drug: ABLC
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Medstar Research Institute:

Primary Outcome Measures:
  • Survival [ Designated as safety issue: No ]
  • Time to Sterilization of CSF [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Infusion related and renal toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment: 18
Study Start Date: January 2007
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01656382

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

No publications provided

Responsible Party: Medstar Research Institute
ClinicalTrials.gov Identifier: NCT01656382     History of Changes
Other Study ID Numbers: 2006-273
Study First Received: April 24, 2007
Last Updated: August 2, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Medstar Research Institute:
ABLC
cryptococcosis

Additional relevant MeSH terms:
Cryptococcosis
Mycoses
Amphotericin B
Liposomal amphotericin B
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Bacterial Agents
Antifungal Agents

ClinicalTrials.gov processed this record on August 28, 2014