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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.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002113
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: April 1996
  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

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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
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
Sponsors and Collaborators
Pfizer
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00002113     History of Changes
Other Study ID Numbers: 213A, R-0202
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:
Meningitis
Cryptococcosis
Drug Therapy, Combination
Fluconazole
Flucytosine
Acquired Immunodeficiency Syndrome

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Meningitis
Meningitis, Cryptococcal
Central Nervous System Diseases
Central Nervous System Fungal Infections
Central Nervous System Infections
Cryptococcosis
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Meningitis, Fungal
Mycoses
Nervous System Diseases
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Fluconazole
Flucytosine
14-alpha Demethylase Inhibitors
Anti-Infective Agents
Antifungal Agents
Antimetabolites
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014