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

Last updated on March 22, 2018

FOR MORE INFORMATION
Study Location
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Cryptococcal Meningitis, HIV Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
13+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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.

NCT00002113
Pfizer
Completed
A Pilot Study of Fluconazole Plus Flucytosine for the Treatment of AIDS Patients With Acute Cryptococcal Meningitis.

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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
Primary Purpose: Treatment
  • Meningitis, Cryptococcal
  • HIV Infections
  • Drug: Flucytosine
  • Drug: Fluconazole
Not Provided
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
Not Provided
Not Provided

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.
Sexes Eligible for Study: All
13 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00002113
213A
R-0202
Not Provided
Not Provided
Not Provided
Not Provided
Pfizer
Not Provided
Not Provided
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

FOR MORE INFORMATION

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