Overview

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

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Liposome
Treatments:
Amphotericin B
Liposomal 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.