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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Meningitis, Cryptococcal, HIV Infections

Intervention / Treatment
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* Drug: Amphotericin B, Lipid-based
* Drug: Amphotericin B


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Amphotericin B, Lipid-based|nan|
|Drug: Amphotericin B|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Meningitis, Liposomes, Cryptococcosis, Acquired Immunodeficiency Syndrome, Amphotericin B, Chemistry, Pharmaceutical