WithdrawnPhase 4

Safety, Efficacy, and Pharmacokinetics of Amphotericin B Lipid Complex

United States0Started 2007-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Diagnosis of cryptococcal meningitis based on any of the following:
✓. 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

Exclusion criteria

✕. 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
✕. Life expectancy of less than 72 hours

What they're measuring

Survival

Time to Sterilization of CSF

Trial details

NCT IDNCT01656382

SponsorMedstar Health Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-01

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