Official Title

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

    N/A
  • Study Type

    Interventional
  • Status

    Completed No Results Posted
  • Intervention/Treatment

    amphotericin b ...
  • Study Participants

    None
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.
Study Started
Nov 02
1999
Last Update
Jun 24
2005
Estimate

Drug Amphotericin B, Lipid-based

Drug Amphotericin B

Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.
Excluded within 2 weeks of study entry:
Any other experimental drug.
No Results Posted