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

Sponsor

Liposome (Industry)

Overall Status

Completed

CT.gov ID

NCT00002019

Collaborator

(none)

Locations

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Meningitis, Cryptococcal HIV Infections	Drug: Amphotericin B, Lipid-based Drug: Amphotericin B	N/A

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 0 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Harbor - UCLA Med Ctr	Torrance	California	United States	90502
2	Dr Thomas Patterson	New Haven	Connecticut	United States	06510
3	Walter Reed Army Med Ctr	Washington	District of Columbia	United States	203075001
4	Rush Presbyterian - Saint Luke's Med Ctr	Chicago	Illinois	United States	60612
5	Natl Naval Med Ctr	Bethesda	Maryland	United States	20889
6	Univ Hosp	Boston	Massachusetts	United States	02118
7	East Orange Veterans Administration Med Ctr	East Orange	New Jersey	United States	07018
8	Saint Michael's Med Ctr	Newark	New Jersey	United States	07102
9	Beth Israel Med Ctr / Peter Krueger Clinic	New York	New York	United States	10003
10	Dr Dorothy Friedberg	New York	New York	United States	10016
11	New York Univ Med Ctr	New York	New York	United States	10016
12	Cornell Univ Med College	New York	New York	United States	10021
13	Saint Luke's - Roosevelt Hosp Ctr	New York	New York	United States	10025
14	Mount Sinai Med Ctr / Jack Martin Fund Clinic	New York	New York	United States	10029
15	Mount Sinai Med Ctr	New York	New York	United States	10029
16	Buckley Braffman Stern Med Associates	Philadelphia	Pennsylvania	United States	19107
17	Univ TX Galveston Med Branch	Galveston	Texas	United States	77550
18	Audie L Murphy Veterans Administration Hosp	San Antonio	Texas	United States	78284
19	Univ of Utah School of Medicine	Salt Lake City	Utah	United States	84132