MeningitisNCT00002010
Open, Non-Comparative Study of Fluconazole in Patients With Coccidioidal Meningitis
A study testing Fluconazole in people with Meningitis and HIV Infections, run by Pfizer at 3 sites in United States.
Trial summary
The study is intended to examine the efficacy of fluconazole for the treatment of coccidioidal meningitis in patients with new onset of infection, relapse of previous infection, or failed previous therapy. Drug efficacy, safety and tolerance will be examined. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Meningitis, HIV Infections
- What is being tested?
- Fluconazole
- How many people
- Not given
- Where
- 3 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:
- Immunosuppressive therapy including corticosteroids and/or cytotoxic agents.
- Antiviral therapy (e.g., zidovudine (AZT)).
- Prophylaxis for Pneumocystis carinii pneumonia (PCP).
- Any exceptions to use of concomitant medications must be approved by Pfizer Central Research prior to study entry.
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- Concurrent Treatment:
- Allowed:
- Radiation therapy for mucocutaneous Kaposi's sarcoma.
- Patients must:
- Be clinically judged to be in need of treatment for coccidioidal meningitis.
- Have > 1 week life expectancy.
- Allowed:
- Immunocompromised patients.
- Patients with renal disease will have the dose of fluconazole adjusted and serum levels may be monitored.
- Prior Medication:
- Allowed:
- Amphotericin B.
- Ketoconazole.
- Miconazole.
Who cannot join
- Co-existing Condition:
- Patients with the following conditions or symptoms are excluded:
- Current antifungal infection that is responding to another agent. Findings of improvement include one of the following, while on other therapy (without subsequent relapse of the item):
- CSF culture conversion from positive to negative.
- OR
- CSF antibody titer decrease of at least one dilution.
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- OR
- Improvement in signs and symptoms of meningitis.
- Have received more than minimal systemic antifungal therapy (see Patient Inclusion Criteria), unless they meet criteria for previous treatment failure or relapse. They must not have received this therapy since the time relapse or failure was documented, except for minimal antifungal therapy allowed in Patient Inclusion Criteria.
- Immediately life-threatening coccidioidomycosis defined as infection of such a degree of clinical severity that the patient would be expected to die within 1 week, if untreated, based on clinical judgment.
- Experienced a prior allergic reaction or major side effect from an imidazole or triazole compound.
- Concurrent Medication:
- Excluded:
- Barbiturates.
- Phenytoin.
- Oral hypoglycemics.
- Coumadin type anticoagulants.
- Other systemic or intrathecal antifungal therapy.
- Other experimental agents with exceptions noted in concomitant medications section.
- Any exceptions to these prohibitions of concomitant medications must be approved by Pfizer Central Research prior to study entry.
- Patients with the following are excluded:
- Are responding or are improving on current antifungal therapy with another agent.
- Have received more than minimal systemic antifungal therapy (see Patient Inclusion Criteria), unless they meet criteria for previous treatment failure or relapse. They must not have received this therapy since the time relapse or failure was documented, except for minimal antifungal therapy allowed in Patient Inclusion Criteria.
- Immediately life-threatening coccidioidomycosis defined as infection of such a degree of clinical severity that the patient would be expected to die within 1 week, if untreated, based on clinical judgment.
- Experienced a prior allergic reaction or major side effect from an imidazole or triazole compound.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Audie L Murphy Veterans Administration Hosp
San Antonio, Texas, 78284
HIV Research Group
San Diego, California, 92102
Tucson Veterans Administration Med Ctr
Tucson, Arizona, 85724
About this study
The study is intended to examine the efficacy of fluconazole for the treatment of coccidioidal meningitis in patients with new onset of infection, relapse of previous infection, or failed previous therapy. Drug efficacy, safety and tolerance will be examined.
- Conditions
- Meningitis, HIV Infections
- Being tested
- Fluconazole
- Keywords
- AIDS-Related Opportunistic Infections, Meningitis, Fluconazole, Coccidioidin, Acquired Immunodeficiency Syndrome, Coccidioidomycosis
- Medical subject headings
- Meningitis, HIV Infections, AIDS-Related Opportunistic Infections, Acquired Immunodeficiency Syndrome, Coccidioidomycosis
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 MeningitisStudies 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
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002010
- Sponsor's protocol ID
- 012P
- Other IDs
- 056-170
- Status last verified
- Feb 1992
- 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
- Open, Non-Comparative Study of Fluconazole in Patients With Coccidioidal Meningitis
- ClinicalTrials.gov ID
- NCT00002010
- Acronym / sponsor ID
- 012P
- Conditions
- Meningitis, HIV Infections
- Keywords
- AIDS-Related Opportunistic Infections, Meningitis, Fluconazole, Coccidioidin, Acquired Immunodeficiency Syndrome, Coccidioidomycosis
- 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.
The study is intended to examine the efficacy of fluconazole for the treatment of coccidioidal meningitis in patients with new onset of infection, relapse of previous infection, or failed previous therapy. Drug efficacy, safety and tolerance will be examined.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (20 listed)
- Immunosuppressive therapy including corticosteroids and/or cytotoxic agents.
- Antiviral therapy (e.g., zidovudine (AZT)).
- Prophylaxis for Pneumocystis carinii pneumonia (PCP).
- Any exceptions to use of concomitant medications must be approved by Pfizer Central Research prior to study entry.
- Radiation therapy for mucocutaneous Kaposi's sarcoma.
Key exclusion criteria (25 listed)
- Current antifungal infection that is responding to another agent. Findings of improvement include one of the following, while on other therapy (without subsequent relapse of the item):
- CSF culture conversion from positive to negative.
- OR
- CSF antibody titer decrease of at least one dilution.
- OR
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.
3 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 and HIV Infections, run by Pfizer at 3 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 20 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 3 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.