Completed

Fluconazole and Flucytosine Combination for AIDS Patients With Acute Cryptococcal Meningitis

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What is being tested

Flucytosine

+ Fluconazole

Drug
Who is being recruted

Blood-Borne Infections+24

+ Neuroinflammatory Diseases

+ Urogenital Diseases

Over 13 Years
+15 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
See protocol details

Summary

Principal SponsorPfizer
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

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.

NCT00002113
Principal SponsorPfizer
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

64 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 13 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsNeuroinflammatory DiseasesUrogenital DiseasesGenital DiseasesBacterial Infections and MycosesCentral Nervous System DiseasesCentral Nervous System InfectionsCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsMycosesNervous System DiseasesRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsMeningitis, FungalCentral Nervous System Fungal InfectionsAcquired Immunodeficiency SyndromeCryptococcosisMeningitisHIV InfectionsMeningitis, Cryptococcal

Criteria

9 inclusion criteria required to participate
Allowed: Antiviral therapy (AZT, DHPG)
Allowed: Prior antiviral therapy (AZT, DHPG)
Allowed: Prophylaxis for Pneumocystis carinii pneumonia
Allowed: Radiation therapy for mucocutaneous Kaposi's sarcoma
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6 exclusion criteria prevent from participating
Concomitant use of any antifungal agent other than study drug
History of allergy to or intolerance of imidazoles, azoles, or flucytosine
More than 1 mg/kg amphotericin B
Relapsing on maintenance triazole therapy for cryptococcal meningitis
Show More Criteria

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Los Angeles County - USC Med Ctr

Los Angeles, United StatesOpen Los Angeles County - USC Med Ctr in Google Maps

UCI Med Ctr

Orange, United States

UCSD Med Ctr - Owen Clinic

San Diego, United States
Completed3 Study Centers