Safety and Efficacy of Amphotericin B Lipid Complex in the Treatment of Cryptococcal Meningitis in Patients With the Acquired Immunodeficiency Syndrome

Completed · Not applicable

Conditions studied: Meningitis, Cryptococcal, HIV Infections

In brief

To evaluate the safety, tolerance and efficacy of three different dosage regimens of Amphotericin B Lipid Complex (ABLC) compared to Fungizone (Amphotericin B) in patients with AIDS and cryptococcal meningitis.

Key facts

Study ID

NCT00002019

Run by

Liposome

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Concurrent Medication:
• Allowed:
• Intravenous pentamidine for treatment of Pneumocystis carinii pneumonia (PCP) but not for prophylaxis.
• Patients must have the following:
• Meet the CDC criteria for diagnosis of AIDS.
• Confirmed episode of acute cryptococcal meningitis.
• Informed consent of the patient or guardian prior to entry.

You may not qualify if…

• Co-existing Condition:
• Patients with the following conditions or symptoms are excluded:
• Clinical evidence of acute or chronic meningitis due to an agent other than Cryptococcus neoformans.
• History of hypersensitivity/anaphylactoid reaction attributed to amphotericin B.
• Any other concomitant condition which, in the opinion of the investigator, would preclude a patient's participation in the study.
• Concurrent Medication:
• Excluded:
• Corticosteroids.
• Salicylates or other drugs known to interfere with prostaglandin synthesis except as specified in protocol.
• Zidovudine.
• Investigational agents.
• Interferon.
• Interleukin-2 (IL-2).
• Steroids.
• Isoprinosine.
• Intrathecal Amphotericin B.
• Intravenous Pentamidine PCP prophylaxis (only treatment).
• Patients with the following are excluded:
• Clinical evidence of acute or chronic meningitis due to an agent other than Cryptococcus neoformans.
• History of hypersensitivity/anaphylactoid reaction attributed to amphotericin B.
• Inability to obtain appropriate follow-up visits.
• Any other concomitant condition which, in the opinion of the investigator, would preclude a patient's participation in the study.
• Prior Medication:
• Excluded within 4 weeks of study entry:
• Amphotericin B.

Where it is running

• Harbor - UCLA Med Ctr — Torrance, California, United States
• Dr Thomas Patterson — New Haven, Connecticut, United States
• Walter Reed Army Med Ctr — Washington D.C., District of Columbia, United States
• Rush Presbyterian - Saint Luke's Med Ctr — Chicago, Illinois, United States
• Natl Naval Med Ctr — Bethesda, Maryland, United States
• Univ Hosp — Boston, Massachusetts, United States
• East Orange Veterans Administration Med Ctr — East Orange, New Jersey, United States
• Saint Michael's Med Ctr — Newark, New Jersey, United States
• Beth Israel Med Ctr / Peter Krueger Clinic — New York, New York, United States
• Dr Dorothy Friedberg — New York, New York, United States
• New York Univ Med Ctr — New York, New York, United States
• Cornell Univ Med College — New York, New York, United States
• Saint Luke's - Roosevelt Hosp Ctr — New York, New York, United States
• Mount Sinai Med Ctr / Jack Martin Fund Clinic — New York, New York, United States
• Mount Sinai Med Ctr — New York, New York, United States
• Buckley Braffman Stern Med Associates — Philadelphia, Pennsylvania, United States
• Univ TX Galveston Med Branch — Galveston, Texas, United States
• Audie L Murphy Veterans Administration Hosp — San Antonio, Texas, United States
• Univ of Utah School of Medicine — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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