Meningitis, CryptococcalNCT00002306
A Study of Fluconazole in the Treatment of Cryptococcal Meningitis in Patients Who Have Not Had Success With Amphotericin B
A study testing Fluconazole in people with Meningitis, Cryptococcal and HIV Infections, run by Pfizer at 14 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Meningitis, Cryptococcal, HIV Infections
- What is being tested?
- Fluconazole
- How many people
- Not given
- Where
- 14 sitesUnited States
- 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Concurrent Medication:
- Allowed:
- Immunosuppressant therapy.
- Antiviral therapy such as zidovudine.
- Prophylaxis for Pneumocystis carinii pneumonia.
- Aerosolized pentamidine.
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- 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 informed consent 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.
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 or azoles.
- Moderate or severe liver disease.
- Concurrent Treatment:
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- 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.
- Life expectancy of < 2 weeks.
- Prior Medication:
- Excluded:
- Coumadin-type anticoagulants.
- Oral hypoglycemics.
- Barbiturates.
- Phenytoin.
- Immunostimulants.
- Investigational drugs or approved (licensed) drugs for investigational indications.
- Prior Treatment:
- Excluded:
- Lymphocyte replacement.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
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 Alabama at Birmingham
Birmingham, Alabama, 35294
Univ Hosp
Boston, Massachusetts, 02118
Cincinnati Veterans Adm Med Ctr / Univ Hosp
Cincinnati, Ohio, 452670405
United States Air Force Med Ctr
Lackland Air Force Base, Texas, 782365300
Saint Luke's - Roosevelt Hosp Ctr
New York, New York, 10025
Southwest Texas Methodist Hosp
San Antonio, Texas, 78229
Univ TX San Antonio Health Science Ctr
San Antonio, Texas, 78284
Washington Univ School of Medicine
St Louis, Missouri, 63108
Univ of South Florida
Tampa, Florida, 33612
Bronx Veterans Administration / Mount Sinai Hosp
The Bronx, New York, 10468
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037
About this study
Official title: Multi-Center Evaluation of Fluconazole (UK-49,858) as Treatment for Acute Cryptococcal Meningitis in Patients Who Have Failed to Respond or Have Experienced Unacceptable Toxicity During Treatment With Amphotericin B
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.
- Conditions
- Meningitis, Cryptococcal, HIV Infections
- Being tested
- Fluconazole
- Keywords
- AIDS-Related Opportunistic Infections, Meningitis, Cryptococcosis, Fluconazole, 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.
FluconazoleDrug
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
- NCT00002306
- Sponsor's protocol ID
- 012I
- Other IDs
- 056-161
- Status last verified
- Feb 1990
- 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
- Multi-Center Evaluation of Fluconazole (UK-49,858) as Treatment for Acute Cryptococcal Meningitis in Patients Who Have Failed to Respond or Have Experienced Unacceptable Toxicity During Treatment With Amphotericin B
- ClinicalTrials.gov ID
- NCT00002306
- Acronym / sponsor ID
- 012I
- Conditions
- Meningitis, Cryptococcal, HIV Infections
- Keywords
- AIDS-Related Opportunistic Infections, Meningitis, Cryptococcosis, Fluconazole, 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 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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (19 listed)
- Immunosuppressant therapy.
- Antiviral therapy such as zidovudine.
- Prophylaxis for Pneumocystis carinii pneumonia.
- Aerosolized pentamidine.
- Radiation therapy for mucocutaneous Kaposi's sarcoma.
Key exclusion criteria (25 listed)
- 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.
- Lymphocyte replacement.
- Evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis.
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 |
|---|---|---|
| Fluconazole | 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.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluconazole in people with Meningitis, Cryptococcal and HIV Infections, run by Pfizer at 14 sites in United States.
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 19 inclusion and 25 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 14 sites in United States. 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.