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A Pilot Study of Fluconazole Plus Flucytosine for the Treatment of AIDS Patients With Acute Cryptococcal Meningitis.

This study has been completed.

Sponsored by: Pfizer
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002113
  Purpose

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 Intervention
Meningitis, Cryptococcal
HIV Infections
Drug: Flucytosine
Drug: Fluconazole

MedlinePlus related topics:   AIDS    Meningitis   

ChemIDplus related topics:   Fluconazole    Flucytosine   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Safety Study
Official Title:   A Pilot Study of Fluconazole Plus Flucytosine for the Treatment of AIDS Patients With Acute Cryptococcal Meningitis.

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment:   64

Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002113

Locations
United States, California
UCI Med Ctr    
      Orange, California, United States, 92668
Los Angeles County - USC Med Ctr    
      Los Angeles, California, United States, 90033
UCSD Med Ctr - Owen Clinic    
      San Diego, California, United States, 921038681

Sponsors and Collaborators
Pfizer
  More Information

Publications:

Study ID Numbers:   213A, R-0202
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002113
Health Authority:   United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Meningitis  
Cryptococcosis  
Drug Therapy, Combination  
Fluconazole
Flucytosine
Acquired Immunodeficiency Syndrome

Study placed in the following topic categories:
Fluconazole
Sexually Transmitted Diseases, Viral
Clotrimazole
Miconazole
Acquired Immunodeficiency Syndrome
Tioconazole
Central Nervous System Diseases
Flucytosine
Immunologic Deficiency Syndromes
Meningitis
Virus Diseases
Mycoses
Central Nervous System Infections
HIV Infections
Sexually Transmitted Diseases
Meningitis, Cryptococcal
Cryptococcosis
Retroviridae Infections

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
RNA Virus Infections
Meningitis, Fungal
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Nervous System Diseases
Infection
Pharmacologic Actions
Antifungal Agents
Therapeutic Uses
Lentivirus Infections
Central Nervous System Fungal Infections

ClinicalTrials.gov processed this record on September 05, 2008




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