NCT00002075

Brief Summary

To compare the safety and effectiveness of fluconazole and amphotericin B, alone or in combination with flucytosine, as treatment for acute cryptococcal meningitis.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

September 1, 1989

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

Meningitis, CryptococcalHIV Infections

Keywords

AIDS-Related Opportunistic InfectionsMeningitisCryptococcosisDrug Therapy, CombinationFluconazoleFlucytosineAcquired Immunodeficiency SyndromeAmphotericin B

Interventions

FlucytosineDRUG
FluconazoleDRUG
Amphotericin BDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Concurrent Medication:
  • Allowed:
  • Immunosuppressant therapy.
  • Antiviral such as zidovudine.
  • Radiation therapy for mucocutaneous Kaposi's sarcoma.
  • Prophylaxis for Pneumocystis carinii pneumonia (PCP) including aerosol pentamidine.
  • Concurrent Treatment:
  • Allowed:
  • Radiation therapy for mucocutaneous Kaposi's sarcoma.
  • Written informed consent must be obtained for each patient, either from the patient himself or from the patient's legal guardian.
  • No prior systemic antifungal therapy for cryptococcosis.
  • Relapse after prior therapy.
  • Success of prior therapy must have been documented by negative cerebrospinal fluid (CSF) culture at the end of therapy. Following prior therapy, such patients may not have received more than 1 mg/kg/wk amphotericin B in the 4 weeks before entry into study.
  • Prior Medication:
  • Allowed:
  • +3 more criteria

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following are excluded:
  • Evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis.
  • History of allergy to or intolerance of imidazoles, azoles, or amphotericin B.
  • Moderate or severe liver disease.
  • Comatose.
  • Unlikely to survive more than 2 weeks.
  • Any exceptions to these prohibitions of concomitant medications must be approved by Pfizer Central Research.
  • Concurrent Medication:
  • Excluded:
  • Coumadin-type anticoagulants.
  • Oral hypoglycemics.
  • Barbiturates.
  • Phenytoin.
  • Immunostimulants.
  • +26 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr Robert Larsen

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Meningitis, CryptococcalHIV InfectionsAIDS-Related Opportunistic InfectionsMeningitisCryptococcosisAcquired Immunodeficiency Syndrome

Interventions

FlucytosineFluconazoleAmphotericin B

Condition Hierarchy (Ancestors)

Meningitis, FungalCentral Nervous System Fungal InfectionsMycosesBacterial Infections and MycosesInfectionsCentral Nervous System InfectionsCentral Nervous System DiseasesNervous System DiseasesNeuroinflammatory DiseasesBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesOpportunistic InfectionsSlow Virus Diseases

Intervention Hierarchy (Ancestors)

CytosinePyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTriazolesAzolesMacrolidesPolyketidesLactonesOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1989-09

Locations

US(1)