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

June 23, 2005 updated by: Liposome
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Liposome

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (ESTIMATE)

August 31, 2001

Study Record Updates

Last Update Posted (ESTIMATE)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

November 1, 1999

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 051A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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