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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.

Sponsored by: Liposome
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002019
  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

MedlinePlus related topics:   AIDS    Meningitis   

ChemIDplus related topics:   Amphotericin B    Lipids   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Dose Comparison, Safety Study
Official Title:   Safety and Efficacy of Amphotericin B Lipid Complex in the Treatment of Cryptococcal Meningitis in Patients With the Acquired Immunodeficiency Syndrome
  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

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
Mount Sinai Med Ctr / Jack Martin Fund Clinic    
      New York, New York, United States, 10029
Saint Luke's - Roosevelt Hosp Ctr    
      New York, New York, United States, 10025
Dr Dorothy Friedberg    
      New York, New York, United States, 10016
New York Univ Med Ctr    
      New York, New York, United States, 10016
Cornell Univ Med College    
      New York, New York, United States, 10021
Beth Israel Med Ctr / Peter Krueger Clinic    
      New York, New York, United States, 10003
Mount Sinai Med Ctr    
      New York, New York, United States, 10029
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)
 

Study ID Numbers:   051A
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002019
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

Study placed in the following topic categories:
Abelcet
Amphotericin B
Sexually Transmitted Diseases, Viral
Clotrimazole
Miconazole
Acquired Immunodeficiency Syndrome
Tioconazole
Central Nervous System Diseases
Immunologic Deficiency Syndromes
Meningitis
Virus Diseases
Mycoses
Central Nervous System Infections
HIV Infections
AmBisome
Sexually Transmitted Diseases
Meningitis, Cryptococcal
Cryptococcosis
Retroviridae Infections

Additional relevant MeSH terms:
Anti-Infective Agents
RNA Virus Infections
Meningitis, Fungal
Antiprotozoal Agents
Slow Virus Diseases
Disease
Immune System Diseases
Nervous System Diseases
Infection
Pharmacologic Actions
Anti-Bacterial Agents
Antiparasitic Agents
Pathologic Processes
Antifungal Agents
Therapeutic Uses
Syndrome
Antibiotics, Antifungal
Lentivirus Infections
Central Nervous System Fungal Infections
Amebicides

ClinicalTrials.gov processed this record on September 16, 2008




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