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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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002019
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: November 1999
  Purpose

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 Intervention
Meningitis, Cryptococcal
HIV Infections
Drug: Amphotericin B, Lipid-based
Drug: Amphotericin B

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
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

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002019

Locations
United States, California
Harbor - UCLA Med Ctr
Torrance, California, United States, 90502
United States, Connecticut
Dr Thomas Patterson
New Haven, Connecticut, United States, 06510
United States, District of Columbia
Walter Reed Army Med Ctr
Washington, District of Columbia, United States, 203075001
United States, Illinois
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States, 60612
United States, Maryland
Natl Naval Med Ctr
Bethesda, Maryland, United States, 20889
United States, Massachusetts
Univ Hosp
Boston, Massachusetts, United States, 02118
United States, New Jersey
East Orange Veterans Administration Med Ctr
East Orange, New Jersey, United States, 07018
Saint Michael's Med Ctr
Newark, New Jersey, United States, 07102
United States, New York
Dr Dorothy Friedberg
New York, New York, United States, 10016
Cornell Univ Med College
New York, New York, United States, 10021
Saint Luke's - Roosevelt Hosp Ctr
New York, New York, United States, 10025
Mount Sinai Med Ctr
New York, New York, United States, 10029
Mount Sinai Med Ctr / Jack Martin Fund Clinic
New York, New York, United States, 10029
Beth Israel Med Ctr / Peter Krueger Clinic
New York, New York, United States, 10003
New York Univ Med Ctr
New York, New York, United States, 10016
United States, Pennsylvania
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
Univ TX Galveston Med Branch
Galveston, Texas, United States, 77550
Audie L Murphy Veterans Administration Hosp
San Antonio, Texas, United States, 78284
United States, Utah
Univ of Utah School of Medicine
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
Liposome
  More Information

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)

ClinicalTrials.gov Identifier: NCT00002019     History of Changes
Other Study ID Numbers: 051A
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Meningitis
Liposomes
Cryptococcosis
Acquired Immunodeficiency Syndrome
Amphotericin B
Chemistry, Pharmaceutical

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Meningitis
Meningitis, Cryptococcal
Syndrome
Central Nervous System Diseases
Central Nervous System Fungal Infections
Central Nervous System Infections
Cryptococcosis
Disease
Immune System Diseases
Lentivirus Infections
Meningitis, Fungal
Mycoses
Nervous System Diseases
Pathologic Processes
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Amphotericin B
Liposomal amphotericin B
Amebicides
Anti-Bacterial Agents
Anti-Infective Agents
Antifungal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on November 25, 2014