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/ALead Sponsor
Taiwan Liposome CompanyStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Meningitis, Cryptococcal HIV InfectionsIntervention/Treatment
amphotericin b ...Study Participants
NoneTo 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.
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.