ClinicalTrials.gg
CompletedNCT00002068Updated Jun 24, 2005

A Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis

An interventional study of Fluconazole and Amphotericin B in Meningitis, Cryptococcal and HIV Infections, sponsored by Pfizer. Completed at 8 sites in 2 countries. Open to participants aged 13 Years and older. Per ClinicalTrials.gov, last updated 2005-06-24.

Sponsored by Pfizer · Not applicable, Interventional, and Treatment

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

Study summary

To compare the safety and effectiveness of fluconazole and amphotericin B, alone or in combination with flucytosine, as treatment for acute cryptococcal meningitis.

02

Conditions studied

  • Meningitis, Cryptococcal
  • HIV Infections

Keywords

  • AIDS-Related Opportunistic Infections
  • Meningitis
  • Cryptococcosis
  • Drug Therapy, Combination
  • Fluconazole
  • Flucytosine
  • Acquired Immunodeficiency Syndrome
  • Amphotericin B
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

Pfizer is the lead sponsor of 3,334 studies on the registry; 149 are open to participants now.

Of its 601 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.

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

04

Who can participate

Ages eligible
13 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:

  • therapy.
  • Antiviral therapy such as zidovudine.
  • Prophylaxis for Pneumocystis carinii pneumonia.

Concurrent Treatment:

Allowed:

  • Radiation therapy for mucocutaneous Kaposi's sarcoma.

Written must be obtained for each patient, either from the patient himself or from the patient's legal guardian.

  • No prior systemic antifungal therapy for cryptococcosis.
  • Relapse after prior therapy.
  • Success of prior therapy must have been documented by negative cerebrospinal fluid (CSF) culture at the end of therapy. Following prior therapy, such patients may not have received more than 1 mg/kg/wk amphotericin B in the 4 weeks before entry into study.

Prior Medication:

Allowed:

  • Immunosuppressant therapy.
  • Antiviral therapy such as zidovudine.
  • Prophylaxis for Pneumocystis carinii pneumonia.

Exclusion criteria

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

  • Evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis.
  • History of allergy to or intolerance of imidazoles, azoles, or amphotericin B.
  • Moderate or severe liver disease.
  • Comatose.
  • Unlikely to survive more than 2 weeks.

Concurrent Medication:

Excluded within 4 weeks of study entry:

  • Greater than 1 mg/kg/wk amphotericin B.
  • Coumadin-type anticoagulants.
  • Oral hypoglycemics.
  • Barbiturates.
  • Phenytoin.
  • Immunostimulants.
  • drugs or approved (licensed) drugs for investigational indications.

Concurrent Treatment:

Excluded:

  • Lymphocyte replacement.

Patients with the following are excluded:

  • Evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis.
  • History of allergy to or intolerance of imidazoles, azoles, or amphotericin B.
  • Moderate or severe liver disease.
  • Comatose.
  • Unlikely to survive more than 2 weeks.

Prior Medication:

Excluded within 4 weeks of study entry:

  • Greater than 1 mg/kg/wk amphotericin B.
  • Coumadin-type anticoagulants.
  • Oral hypoglycemics.
  • Barbiturates.
  • Phenytoin.
  • Immunostimulants.
  • Investigational drugs or approved (licensed) drugs for investigational indications.

Prior Treatment:

Excluded:

  • Lymphocyte replacement.
Terms in these criteria, in plain language(3)

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.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

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.

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

8 sites
  • Davies Med Ctr
    San Francisco, California 94114, United States
  • Christiana Hosp / Med Ctr of Delaware
    Wilmington, Delaware 19899, United States
  • Univ of South Florida
    Tampa, Florida 33612, United States
  • Univ of Maryland / Inst of Human Virology
    Baltimore, Maryland 212011192, United States
  • Henry Ford Hosp
    Detroit, Michigan 48202, United States
  • Harlem AIDS Treatment Group / Harlem Hosp Ctr
    New York, New York 10037, United States
  • Univ of Tennessee
    Memphis, Tennessee 38163, United States
  • Saint Michael's Hosp
    Toronto, Ontario, Canada
07

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 ↗
08

Registry details

Key details

Study ID
NCT00002068
Lead sponsor
Pfizer
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 Feb 1990. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Fluconazole · Amphotericin B

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