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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

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.

Detailed Description

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Conditions

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Meningitis, Cryptococcal HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Amphotericin B, Lipid-based

Intervention Type DRUG

Amphotericin B

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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Harbor - UCLA Med Ctr

Torrance, California, United States

Site Status

Dr Thomas Patterson

New Haven, Connecticut, United States

Site Status

Walter Reed Army Med Ctr

Washington D.C., District of Columbia, United States

Site Status

Rush Presbyterian - Saint Luke's Med Ctr

Chicago, Illinois, United States

Site Status

Natl Naval Med Ctr

Bethesda, Maryland, United States

Site Status

Univ Hosp

Boston, Massachusetts, United States

Site Status

East Orange Veterans Administration Med Ctr

East Orange, New Jersey, United States

Site Status