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

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Flucytosine

Fluconazole

About this trial

This is an interventional treatment trial for Meningitis, Cryptococcal focused on measuring Meningitis, Cryptococcosis, Drug Therapy, Combination, Fluconazole, Flucytosine, Acquired Immunodeficiency Syndrome

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Los Angeles County - USC Med Ctr
UCI Med Ctr
UCSD Med Ctr - Owen Clinic

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00002113

First Posted

November 2, 1999

Last Updated

June 23, 2005

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00002113

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 1996

Overall Recruitment Status

Completed

Study Start Date

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Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Name of the Sponsor

Pfizer

4. Oversight

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Meningitis, Cryptococcal, HIV Infections

Keywords

Meningitis, Cryptococcosis, Drug Therapy, Combination, Fluconazole, Flucytosine, Acquired Immunodeficiency Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Allocation

Randomized

Enrollment

64 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Flucytosine

Intervention Type

Drug

Intervention Name(s)

Fluconazole

10. Eligibility

Sex

All

Minimum Age & Unit of Time

13 Years

Accepts Healthy Volunteers

No

Eligibility 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.

Facility Information:

Facility Name

Los Angeles County - USC Med Ctr

City

Los Angeles

State/Province

California

ZIP/Postal Code

90033

Country

United States

Facility Name

UCI Med Ctr

City

Orange

State/Province

California

ZIP/Postal Code

92668

Country

United States

Facility Name

UCSD Med Ctr - Owen Clinic

City

San Diego

State/Province

California

ZIP/Postal Code

921038681

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

7803641

Citation

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. doi: 10.1093/clinids/19.4.741.

Results Reference

background

Meningitis, Cryptococcal, HIV Infections

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial