Open, Non-Comparative Study of Fluconazole in Patients With Coccidioidal Meningitis
This study has been completed.
Sponsor:
Pfizer
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002010
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: February 1992
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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.
Condition | Intervention |
---|---|
Meningitis HIV Infections |
Drug: Fluconazole |
Study Type: | Interventional |
Study Design: | Endpoint Classification: Safety Study Masking: Open Label Primary Purpose: Treatment |
Official Title: | Open, Non-Comparative Study of Fluconazole in Patients With Coccidioidal Meningitis |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
Drug Information available for:
Fluconazole
U.S. FDA Resources
Further study details as provided by NIH AIDS Clinical Trials Information Service:
![](https://webarchive.library.unt.edu/web/20130312224047im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria
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.
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.
Exclusion Criteria
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.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00002010
Locations
United States, Arizona | |
Tucson Veterans Administration Med Ctr | |
Tucson, Arizona, United States, 85724 | |
United States, California | |
HIV Research Group | |
San Diego, California, United States, 92102 | |
United States, Texas | |
Audie L Murphy Veterans Administration Hosp | |
San Antonio, Texas, United States, 78284 |
Sponsors and Collaborators
Pfizer
![](https://webarchive.library.unt.edu/web/20130312224047im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
No publications provided
ClinicalTrials.gov Identifier: | NCT00002010 History of Changes |
Other Study ID Numbers: | 012P, 056-170 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
Health Authority: | United States: Food and Drug Administration |
Keywords provided by NIH AIDS Clinical Trials Information Service:
AIDS-Related Opportunistic Infections Meningitis Fluconazole |
Coccidioidin Acquired Immunodeficiency Syndrome Coccidioidomycosis |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Meningitis Coccidioidomycosis Meningitis, Fungal Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
Central Nervous System Infections Central Nervous System Diseases Nervous System Diseases Mycoses Central Nervous System Fungal Infections Fluconazole Antifungal Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions 14-alpha Demethylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on March 10, 2013