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A Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis

Primary Purpose

Meningitis, Cryptococcal, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Fluconazole
Amphotericin B
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Meningitis, Cryptococcal focused on measuring AIDS-Related Opportunistic Infections, Meningitis, Cryptococcosis, Drug Therapy, Combination, Fluconazole, Flucytosine, Acquired Immunodeficiency Syndrome, Amphotericin B

Eligibility Criteria

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

Inclusion Criteria Concurrent Medication: Allowed: Immunosuppressant therapy. Antiviral therapy such as zidovudine. Prophylaxis for Pneumocystis carinii pneumonia. 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: Immunosuppressant therapy. Antiviral therapy such as zidovudine. Prophylaxis for Pneumocystis carinii pneumonia. Exclusion Criteria 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. Concurrent Medication: Excluded within 4 weeks of study entry: Greater than 1 mg/kg/wk amphotericin B. Coumadin-type anticoagulants. Oral hypoglycemics. Barbiturates. Phenytoin. Immunostimulants. Investigational drugs or approved (licensed) drugs for investigational indications. Concurrent Treatment: Excluded: Lymphocyte replacement. 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. Prior Medication: Excluded within 4 weeks of study entry: Greater than 1 mg/kg/wk amphotericin B. Coumadin-type anticoagulants. Oral hypoglycemics. Barbiturates. Phenytoin. Immunostimulants. Investigational drugs or approved (licensed) drugs for investigational indications. Prior Treatment: Excluded: Lymphocyte replacement.

Sites / Locations

  • Davies Med Ctr
  • Christiana Hosp / Med Ctr of Delaware
  • Univ of South Florida
  • Univ of Maryland / Inst of Human Virology
  • Henry Ford Hosp
  • Harlem AIDS Treatment Group / Harlem Hosp Ctr
  • Univ of Tennessee
  • Saint Michael's Hosp

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00002068
Brief Title
A Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis
Official Title
A Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis
Study Type
Interventional

2. Study Status

Record Verification Date
February 1990
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meningitis, Cryptococcal, HIV Infections
Keywords
AIDS-Related Opportunistic Infections, Meningitis, Cryptococcosis, Drug Therapy, Combination, Fluconazole, Flucytosine, Acquired Immunodeficiency Syndrome, Amphotericin B

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Fluconazole
Intervention Type
Drug
Intervention Name(s)
Amphotericin B

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Concurrent Medication: Allowed: Immunosuppressant therapy. Antiviral therapy such as zidovudine. Prophylaxis for Pneumocystis carinii pneumonia. 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: Immunosuppressant therapy. Antiviral therapy such as zidovudine. Prophylaxis for Pneumocystis carinii pneumonia. Exclusion Criteria 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. Concurrent Medication: Excluded within 4 weeks of study entry: Greater than 1 mg/kg/wk amphotericin B. Coumadin-type anticoagulants. Oral hypoglycemics. Barbiturates. Phenytoin. Immunostimulants. Investigational drugs or approved (licensed) drugs for investigational indications. Concurrent Treatment: Excluded: Lymphocyte replacement. 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. Prior Medication: Excluded within 4 weeks of study entry: Greater than 1 mg/kg/wk amphotericin B. Coumadin-type anticoagulants. Oral hypoglycemics. Barbiturates. Phenytoin. Immunostimulants. Investigational drugs or approved (licensed) drugs for investigational indications. Prior Treatment: Excluded: Lymphocyte replacement.
Facility Information:
Facility Name
Davies Med Ctr
City
San Francisco
State/Province
California
ZIP/Postal Code
94114
Country
United States
Facility Name
Christiana Hosp / Med Ctr of Delaware
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19899
Country
United States
Facility Name
Univ of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Univ of Maryland / Inst of Human Virology
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
212011192
Country
United States
Facility Name
Henry Ford Hosp
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Harlem AIDS Treatment Group / Harlem Hosp Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10037
Country
United States
Facility Name
Univ of Tennessee
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38163
Country
United States
Facility Name
Saint Michael's Hosp
City
Toronto
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

A Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis

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