Meningitis, CryptococcalNCT00002305
A Comparison of Fluconazole and Amphotericin B in the Treatment of Cryptococcal Meningitis
A study testing Flucytosine, Fluconazole and Amphotericin B in people with Meningitis, Cryptococcal and HIV Infections, run by Pfizer at 45 sites in 2 countries.
Trial summary
To compare the safety and effectiveness of fluconazole and amphotericin B, alone or in combination with flucytosine, as treatment for acute cryptococcal meningitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meningitis, Cryptococcal, HIV Infections
- What is being tested?
- Flucytosine, Fluconazole and Amphotericin B
- How many people
- Not given
- Where
- 45 sitesin 2 countries
- Study dates
- Start not givento not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Concurrent Medication:
- Allowed:
- Immunosuppressant therapy.
- Antiviral therapy such as zidovudine.
- Prophylaxis for Pneumocystis carinii pneumonia.
- Concurrent Treatment:
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- Allowed:
- Radiation therapy for mucocutaneous Kaposi's sarcoma.
- Written informed consent 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.
Who cannot join
- 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.
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- Unlikely to survive more than 2 weeks.
- Any exceptions to these prohibitions of concomitant medications must be approved by Pfizer Central Research.
- Concurrent Medication:
- Excluded:
- Coumadin-type anticoagulants.
- Oral hypoglycemics.
- Barbiturates.
- Phenytoin.
- Immunostimulants.
- Investigational drugs or approved (licensed) drugs for investigational indications.
- Any exceptions to these prohibitions of concomitant medications must be approved by Pfizer Central Research.
- Excluded within 4 weeks of study entry:
- Greater than 1 mg/kg/wk amphotericin B.
- 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:
- Coumadin-type anticoagulants.
- Oral hypoglycemics.
- Barbiturates.
- Phenytoin.
- Immunostimulants.
- Investigational drugs or approved (licensed) drugs for investigational indications.
- Excluded within 4 weeks of study entry:
- Greater than 1 mg/kg/wk amphotericin B.
- Prior Treatment:
- Excluded:
- Lymphocyte replacement.
Trial locations and contacts
45 sites in 2 countries.
45 sites in 2 countries
United States44 sites
Albany Med College / AIDS Treatment Ctr
Albany, New York, 12203
Ann Arbor Veterans Administration Med Ctr
Ann Arbor, Michigan, 48105
Emory Univ School of Medicine
Atlanta, Georgia, 30303
Med College of Georgia
Augusta, Georgia, 30912
Univ of Maryland / Inst of Human Virology
Baltimore, Maryland, 212011192
Loch Raven Veterans Hosp
Baltimore, Maryland, 21218
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
New England Med Ctr
Boston, Massachusetts, 02111
Univ Hosp
Boston, Massachusetts, 02118
Univ of North Carolina School of Medicine
Chapel Hill, North Carolina, 275997215
Northwestern Univ Med School
Chicago, Illinois, 60611
Cincinnati Veterans Adm Med Ctr / Univ Hosp
Cincinnati, Ohio, 452670405
Ohio State Univ Hosp
Columbus, Ohio, 43210
Dr Daniel Barbaro
Dallas, Texas, 75235
DeKalb Gen Hosp
Decatur, Georgia, 30033
Harper Hosp
Detroit, Michigan, 48201
Henry Ford Hosp
Detroit, Michigan, 48202
Univ TX Galveston Med Branch
Galveston, Texas, 77550
Jewish Hosp Ctr Affiliation
Jamaica, New York, 11432
United States Air Force Med Ctr
Lackland Air Force Base, Texas, 782365300
UCLA CARE Ctr
Los Angeles, California, 90095
Univ of Tennessee
Memphis, Tennessee, 38163
Univ of Miami School of Medicine
Miami, Florida, 331361013
Louisiana State Univ School of Medicine
New Orleans, Louisiana, 70112
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112
Chelsea Village Med Ctr
New York, New York, 10014
Mem Sloan - Kettering Cancer Ctr
New York, New York, 10021
Saint Luke's - Roosevelt Hosp Ctr
New York, New York, 10025
Columbia Univ
New York, New York, 10032
Harlem AIDS Treatment Group / Harlem Hosp Ctr
New York, New York, 10037
Dr Michael Bach
Portland, Maine, 04102
Richmond AIDS Consortium
Richmond, Virginia, 23219
Univ TX San Antonio Health Science Ctr
San Antonio, Texas, 78284
Dr Shelly Gordon
San Francisco, California, 94115
Dr Martin Mass
San Francisco, California, 94120
CHG-118 Group Health / Cooperative of Puget Sound
Seattle, Washington, 98112
Dr Paul Rothman
Sherman Oaks, California, 91403
Washington Univ School of Medicine
St Louis, Missouri, 63108
Univ of South Florida
Tampa, Florida, 33612
Montefiore Med Ctr / Bronx Municipal Hosp
The Bronx, New York, 10467
Bronx Veterans Administration / Mount Sinai Hosp
The Bronx, New York, 10468
Tucson Veterans Administration Med Ctr
Tucson, Arizona, 85724
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037
Christiana Hosp / Med Ctr of Delaware
Wilmington, Delaware, 19899
About this study
Official title: Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis
To compare the safety and effectiveness of fluconazole and amphotericin B, alone or in combination with flucytosine, as treatment for acute cryptococcal meningitis.
- Conditions
- Meningitis, Cryptococcal, HIV Infections
- Being tested
- Flucytosine, Fluconazole, Amphotericin B
- Keywords
- AIDS-Related Opportunistic Infections, Meningitis, Cryptococcosis, Drug Therapy, Combination, Fluconazole, Flucytosine, Acquired Immunodeficiency Syndrome, Amphotericin B
- Medical subject headings
- Meningitis, Cryptococcal, HIV Infections, AIDS-Related Opportunistic Infections, Meningitis, Cryptococcosis, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlucytosineDrug
FluconazoleDrug
Amphotericin BDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meningitis, CryptococcalStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002305
- Sponsor's protocol ID
- 012F
- Other IDs
- 056-159
- Status last verified
- Dec 1989
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis
- ClinicalTrials.gov ID
- NCT00002305
- Acronym / sponsor ID
- 012F
- Conditions
- Meningitis, Cryptococcal, HIV Infections
- Keywords
- AIDS-Related Opportunistic Infections, Meningitis, Cryptococcosis, Drug Therapy, Combination, Fluconazole, Flucytosine, Acquired Immunodeficiency Syndrome, Amphotericin B
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the safety and effectiveness of fluconazole and amphotericin B, alone or in combination with flucytosine, as treatment for acute cryptococcal meningitis.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Immunosuppressant therapy.
- Antiviral therapy such as zidovudine.
- Prophylaxis for Pneumocystis carinii pneumonia.
- Radiation therapy for mucocutaneous Kaposi's sarcoma.
- Written informed consent must be obtained for each patient, either from the patient himself or from the patient's legal guardian.
Key exclusion criteria (41 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flucytosine | Drug | – |
| Fluconazole | Drug | – |
| Amphotericin B | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
45 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flucytosine, Fluconazole and Amphotericin B in people with Meningitis, Cryptococcal and HIV Infections, run by Pfizer at 45 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 41 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.