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

Liposome

Status: Completed

Conditions: Meningitis, Cryptococcal; HIV Infections

Treatments: Drug: Amphotericin B; Drug: Amphotericin B, Lipid-based

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002019

051A

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.