Safety and Efficacy of Amphotericin B Lipid Complex in the Treatment of Cryptococcal Meningitis in Patients With the Acquired Immunodeficiency Syndrome
1 other identifier
interventional
N/A
1 country
19
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
November 1, 1999
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Liposomelead
Study Sites (19)
Harbor - UCLA Med Ctr
Torrance, California, 90502, United States
Dr Thomas Patterson
New Haven, Connecticut, 06510, United States
Walter Reed Army Med Ctr
Washington D.C., District of Columbia, 203075001, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612, United States
Natl Naval Med Ctr
Bethesda, Maryland, 20889, United States
Univ Hosp
Boston, Massachusetts, 02118, United States
East Orange Veterans Administration Med Ctr
East Orange, New Jersey, 07018, United States
Saint Michael's Med Ctr
Newark, New Jersey, 07102, United States
Beth Israel Med Ctr / Peter Krueger Clinic
New York, New York, 10003, United States
Dr Dorothy Friedberg
New York, New York, 10016, United States
New York Univ Med Ctr
New York, New York, 10016, United States
Cornell Univ Med College
New York, New York, 10021, United States
Saint Luke's - Roosevelt Hosp Ctr
New York, New York, 10025, United States
Mount Sinai Med Ctr / Jack Martin Fund Clinic
New York, New York, 10029, United States
Mount Sinai Med Ctr
New York, New York, 10029, United States
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, 19107, United States
Univ TX Galveston Med Branch
Galveston, Texas, 77550, United States
Audie L Murphy Veterans Administration Hosp
San Antonio, Texas, 78284, United States
Univ of Utah School of Medicine
Salt Lake City, Utah, 84132, United States
Related Publications (1)
al-Haddadin D, Fan-Havard P, Boghossian J, Marton R, Vincent-Graber D, Dungo L, Eng RH, Johnson ES. Amphotericin B-lipid complex (ABLC) in treatment of cryptococcal meningitis in AIDS. Int Conf AIDS. 1992 Jul 19-24;8(2):B109 (abstract no PoB 3132)
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1999-11