Safety and Efficacy of Amphotericin B Lipid Complex in the Treatment of Cryptococcal Meningitis in Patients With the Acquired Immunodeficiency Syndrome
Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Meningitis, Cryptococcal; HIV Infections
Intervention: Amphotericin B, Lipid-based (Drug); Amphotericin B (Drug)
Phase: N/A
Status: Completed
Sponsored by: Liposome
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.
Clinical Details
Official title: Safety and Efficacy of Amphotericin B Lipid Complex in the Treatment of Cryptococcal Meningitis in Patients With the Acquired Immunodeficiency Syndrome
Study design: Treatment, Dose Comparison, Safety Study
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Harbor - UCLA Med Ctr, Torrance, California 90502, United States
Dr Thomas Patterson, New Haven, Connecticut 06510, United States
Walter Reed Army Med Ctr, Washington, 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
Mount Sinai Med Ctr / Jack Martin Fund Clinic, New York, New York 10029, United States
Saint Luke's - Roosevelt Hosp Ctr, New York, New York 10025, 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
Beth Israel Med Ctr / Peter Krueger Clinic, New York, New York 10003, 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
Additional Information
Related publications: 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)
Last updated: June 23, 2005
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