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

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002113 on ClinicalTrials.gov Archive Site
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A Pilot Study of Fluconazole Plus Flucytosine for the Treatment of AIDS Patients With Acute Cryptococcal Meningitis.
A Pilot Study of Fluconazole Plus Flucytosine for the Treatment of AIDS Patients With Acute Cryptococcal Meningitis.

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Primary Purpose: Treatment
  • Meningitis, Cryptococcal
  • HIV Infections
  • Drug: Flucytosine
  • Drug: Fluconazole
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Larsen RA, Bozzette SA, Jones BE, Haghighat D, Leal MA, Forthal D, Bauer M, Tilles JG, McCutchan JA, Leedom JM. Fluconazole combined with flucytosine for treatment of cryptococcal meningitis in patients with AIDS. Clin Infect Dis. 1994 Oct;19(4):741-5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
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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.
Both
13 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002113
213A, R-0202
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Pfizer
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NIH AIDS Clinical Trials Information Service
April 1996

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP