HIV Infections Clinical Trial
Official title:
A Pilot Study of Fluconazole Plus Flucytosine for the Treatment of AIDS Patients With Acute Cryptococcal Meningitis.
NCT number | NCT00002113 |
Other study ID # | 213A |
Secondary ID | R-0202 |
Status | Completed |
Phase | N/A |
First received | November 2, 1999 |
Last updated | June 23, 2005 |
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.
Status | Completed |
Enrollment | 64 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 13 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety Study, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Los Angeles County - USC Med Ctr | Los Angeles | California |
United States | UCI Med Ctr | Orange | California |
United States | UCSD Med Ctr - Owen Clinic | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
United States,
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. — View Citation
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