A Pilot Study of Fluconazole Plus Flucytosine for the Treatment of AIDS Patients With Acute Cryptococcal Meningitis.
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| ClinicalTrials.gov Identifier: NCT00002113 |
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Recruitment Status
:
Completed
First Posted
: August 31, 2001
Last Update Posted
: June 24, 2005
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To evaluate and estimate the safety and efficacy of the combination of fluconazole and flucytosine as treatment for acute cryptococcal meningitis in patients with AIDS.
Fluconazole and flucytosine have different mechanisms of action. Since fluconazole has not been associated with hematologic suppression and does not produce renal impairment that can result in higher serum flucytosine levels, this combination may be better tolerated than is amphotericin B plus flucytosine.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Meningitis, Cryptococcal HIV Infections | Drug: Flucytosine Drug: Fluconazole | Not Applicable |
Fluconazole and flucytosine have different mechanisms of action. Since fluconazole has not been associated with hematologic suppression and does not produce renal impairment that can result in higher serum flucytosine levels, this combination may be better tolerated than is amphotericin B plus flucytosine.
Patients in each cohort receive a lower dose of fluconazole alone or in combination with flucytosine, or a higher dose of fluconazole alone. Doses in subsequent cohorts are escalated if safety data in the previous cohort is satisfactory. Patients are evaluated weekly for the first 4 weeks and every 2 weeks thereafter. Therapy continues until 8 weeks after the CSF becomes culture negative, up to a maximum of 26 weeks.
| Study Type : | Interventional (Clinical Trial) |
| Enrollment : | 64 participants |
| Allocation: | Randomized |
| Primary Purpose: | Treatment |
| Official Title: | A Pilot Study of Fluconazole Plus Flucytosine for the Treatment of AIDS Patients With Acute Cryptococcal Meningitis. |
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| Ages Eligible for Study: | 13 Years and older (Child, Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
- Antiviral therapy (AZT, DHPG).
- Prophylaxis for Pneumocystis carinii pneumonia.
- Treatment for intercurrent opportunistic infection.
Concurrent Treatment:
Allowed:
- Radiation therapy for mucocutaneous Kaposi's sarcoma.
Patients must have:
- AIDS.
- Evidence of Cryptococcal neoformans in culture or lumbar CSF OR clinical and CSF findings compatible with cryptococcal meningitis.
- No evidence of acute or chronic meningitis of any etiology other than cryptococcosis.
- Life expectancy of at least 2 weeks.
Prior Medication:
Allowed:
- Prior antiviral therapy (AZT, DHPG).
- Prophylaxis for Pneumocystis carinii pneumonia.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
- Relapsing on maintenance triazole therapy for cryptococcal meningitis.
- Unable to take oral medication.
Concurrent Medication:
Excluded:
- Concomitant use of any antifungal agent other than study drug.
Patients with the following prior conditions are excluded:
History of allergy to or intolerance of imidazoles, azoles, or flucytosine.
Prior Medication:
Excluded:
- More than 1 mg/kg amphotericin B.
- Systemic antifungal agents within 7 days prior to study entry.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002113
| United States, California | |
| Los Angeles County - USC Med Ctr | |
| Los Angeles, California, United States, 90033 | |
| UCI Med Ctr | |
| Orange, California, United States, 92668 | |
| UCSD Med Ctr - Owen Clinic | |
| San Diego, California, United States, 921038681 | |
Publications:
| ClinicalTrials.gov Identifier: | NCT00002113 History of Changes |
| Other Study ID Numbers: |
213A R-0202 |
| First Posted: | August 31, 2001 Key Record Dates |
| Last Update Posted: | June 24, 2005 |
| Last Verified: | April 1996 |
Keywords provided by NIH AIDS Clinical Trials Information Service:
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Meningitis Cryptococcosis Drug Therapy, Combination |
Fluconazole Flucytosine Acquired Immunodeficiency Syndrome |
Additional relevant MeSH terms:
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HIV Infections Meningitis Meningitis, Cryptococcal Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Central Nervous System Diseases Nervous System Diseases Meningitis, Fungal Central Nervous System Fungal Infections |
Mycoses Cryptococcosis Central Nervous System Infections Fluconazole Flucytosine Antifungal Agents Anti-Infective Agents 14-alpha Demethylase Inhibitors Cytochrome P-450 Enzyme Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Steroid Synthesis Inhibitors Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |