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Clinical Trials

MainTitle

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

This study has been completed
Sponsor
Pfizer


Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier
NCT00002113

First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: April 1996
History of Changes
Purpose

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
Primary Purpose: Treatment
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:

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

Eligibility

Ages Eligible for Study: 13 Years and older  
Sexes Eligible for Study: All  
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

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

More Information


Responsible Party: Pfizer  
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  

Keywords provided by NIH AIDS Clinical Trials Information Service:

Meningitis
Cryptococcosis
Drug Therapy, Combination
Fluconazole
Flucytosine
Acquired Immunodeficiency Syndrome

Additional relevant MeSH terms:
HIV Infections
Meningitis
Meningitis, Cryptococcal
Fluconazole
Flucytosine

ClinicalTrials.gov processed this data on October 16, 2017
This information is provided by ClinicalTrials.gov.