ClinicalTrials.gg
CompletedNCT00002019Updated Jun 24, 2005

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

An interventional study of Amphotericin B, Lipid-based and Amphotericin B in Meningitis, Cryptococcal and HIV Infections, sponsored by Liposome. Completed at 19 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2005-06-24.

Sponsored by Liposome · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Meningitis, Cryptococcal
  • HIV Infections

Keywords

  • Meningitis
  • Liposomes
  • Cryptococcosis
  • Acquired Immunodeficiency Syndrome
  • Amphotericin B
  • Chemistry, Pharmaceutical
03

In context

Meningitis, Cryptococcal

54 studies on the registry are indexed under Meningitis, Cryptococcal; 6 are open to participants now.

Browse Meningitis, Cryptococcal studies →

Lead sponsor

This is the only study on the registry with Liposome as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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.
  • of the patient or guardian prior to entry.

Exclusion criteria

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 /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:

  • .
  • Salicylates or other drugs known to interfere with prostaglandin synthesis except as specified in protocol.
  • Zidovudine.
  • 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.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Treatment

Interventions

06

Study locations

19 sites
  • 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
  • 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
07

References and documents

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)
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00002019
Lead sponsor
Liposome
First posted
Aug 31, 2001
Last update
Jun 24, 2005
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 1999. You cannot join it, but the record below documents what was studied.

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