Safety, Efficacy, and Pharmacokinetics of Amphotericin B Lipid Complex

MedStar Health

Status and phase: Withdrawn; Phase 4

Conditions: Invasive Cryptococcosis

Treatments: Drug: ABLC

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01656382

2006-273

Details and patient eligibility

About

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.

Full 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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

5 mg/kg/d ABLC x 14 days

Active Comparator group

Description:

5 mg/kg/d of Amphotericin B Lipid Complex for 14 days

Treatment:

Drug: ABLC

10/kg/kg/d x 7 days

Experimental group

Description:

10 mg/kg/d of Amphotericin B Lipid Complex for 7 days

Treatment:

Drug: ABLC