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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00002019
Enrollment
Unknown
Registered
2001-08-31
Start date
Unknown
Completion date
Unknown
Last updated
2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections, Meningitis, Cryptococcal

Keywords

Meningitis, Liposomes, Cryptococcosis, Acquired Immunodeficiency Syndrome, Amphotericin B, Chemistry, Pharmaceutical

Brief 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.

Interventions

DRUGAmphotericin B, Lipid-based
DRUGAmphotericin B

Sponsors

Liposome
Lead SponsorINDUSTRY

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026