Safety, Efficacy, and Pharmacokinetics of Amphotericin B Lipid Complex

NCT01656382 | Withdrawn Phase 4

• 1 other identifier: 2006-273
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Invasive Cryptococcosis

Keywords

ABLC; cryptococcosis

Outcome Measures

Primary Outcomes (2)

• Survival

• Time to Sterilization of CSF

Secondary Outcomes (1)

• Infusion related and renal toxicity

Study Arms (2)

5 mg/kg/d ABLC x 14 days

ACTIVE COMPARATOR

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

Drug: ABLC

10/kg/kg/d x 7 days

EXPERIMENTAL

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

Drug: ABLC

Interventions

ABLC DRUG

10/kg/kg/d x 7 days; 5 mg/kg/d ABLC x 14 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medstar Health Research Institute: lead
• Enzon Pharmaceuticals, Inc.: collaborator

Study Sites (1)

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

MeSH Terms

Conditions

Cryptococcosis

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections

Study Officials

• Shmuel Shoham, MD

  Medstar Health Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2007
• First Posted: August 3, 2012
• Study Start: January 1, 2007
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: February 17, 2021

Record last verified: 2021-02

Locations

US (1)