ClinicalTrials.gg
CompletedNCT00002306Updated Jun 24, 2005

A Study of Fluconazole in the Treatment of Cryptococcal Meningitis in Patients Who Have Not Had Success With Amphotericin B

An interventional study of Fluconazole in Meningitis, Cryptococcal and HIV Infections, sponsored by Pfizer. Completed at 14 sites in United States. 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 evaluate the safety and effectiveness of fluconazole as treatment for acute cryptococcal meningitis in patients who have had an unsatisfactory response to or have experienced unacceptable toxicity with amphotericin B.

02

Conditions studied

  • Meningitis, Cryptococcal
  • HIV Infections

Keywords

  • AIDS-Related Opportunistic Infections
  • Meningitis
  • Cryptococcosis
  • Fluconazole
  • 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.
  • Aerosolized pentamidine.

Concurrent Treatment:

Allowed:

  • Radiation therapy for mucocutaneous Kaposi's sarcoma.

Not previously treated for acute cryptococcal meningitis and not eligible for Pfizer Central Research, protocol #159.

  • Patients must have a baseline cerebrospinal fluid (CSF) culture-positive for Cryptococcus neoformans.
  • Written must be obtained for each patient, either from the patient himself or from the patient's legal guardian.
  • Each individual patient must be approved by Pfizer Central Research prior to study entry.

Prior Medication:

Allowed:

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

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 or azoles.
  • Moderate or severe liver disease.

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 or azoles.
  • Moderate or severe liver disease.
  • Satisfactory response to amphotericin B and have received a total amphotericin B dose of 15 mg/kg or more since CSF culture documentation of the current episode of acute cryptococcal meningitis.
  • of \< 2 weeks.

Prior Medication:

Excluded:

  • Coumadin-type anticoagulants.
  • Oral hypoglycemics.
  • Barbiturates.
  • Phenytoin.
  • Immunostimulants.
  • drugs or approved (licensed) drugs for investigational indications.

Prior Treatment:

Excluded:

  • Lymphocyte replacement.
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.

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.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

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

14 sites
  • Univ of Alabama at Birmingham
    Birmingham, Alabama 35294, United States
  • George Washington Univ Med Ctr
    Washington, District of Columbia 20037, United States
  • Univ of South Florida
    Tampa, Florida 33612, United States
  • Emory Univ School of Medicine
    Atlanta, Georgia 30303, United States
  • Med College of Georgia
    Augusta, Georgia 30912, United States
  • Univ Hosp
    Boston, Massachusetts 02118, United States
  • Ann Arbor Veterans Administration Med Ctr
    Ann Arbor, Michigan 48105, United States
  • Washington Univ School of Medicine
    St. Louis, Missouri 63108, United States
  • Bronx Veterans Administration / Mount Sinai Hosp
    Bronx, New York 10468, United States
  • Saint Luke's - Roosevelt Hosp Ctr
    New York, New York 10025, United States
  • Cincinnati Veterans Adm Med Ctr / Univ Hosp
    Cincinnati, Ohio 452670405, United States
  • United States Air Force Med Ctr
    Lackland Air Force Base, Texas 782365300, United States
  • Southwest Texas Methodist Hosp
    San Antonio, Texas 78229, United States
  • Univ TX San Antonio Health Science Ctr
    San Antonio, Texas 78284, United States
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
NCT00002306
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.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Fluconazole

Start the discussion