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Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Maintenance Treatment for the Prevention of Relapse of Cryptococcal Meningitis in Patients With Acquired Immunodeficiency Syndrome

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, Fluconazole, Acquired Immunodeficiency Syndrome, Amphotericin B

Eligibility Criteria

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

Inclusion Criteria Concurrent Medication: Allowed: Antivirals such as zidovudine. Prophylaxis (including aerosolized pentamidine) for Pneumocystis carinii pneumonia (PCP). Pfizer must be notified if the patient is receiving ganciclovir (DHPG) at entry. Concurrent Treatment: Allowed: Radiation therapy for mucocutaneous Kaposi's sarcoma. Patients must be oriented to person, place, and time, and able to give written informed consent. Patients must have had an acute episode of cryptococcal meningitis that was documented by recovery and identification of Cryptococcus neoformans from lumbar cerebrospinal fluid (CSF) culture within 6 months prior to entry. Minimum total dose of 15 mg/kg of amphotericin B must have been given (either alone or in combination with flucytosine) during primary therapy. Patients need not be receiving amphotericin B at the time of randomization but must begin study maintenance therapy within 6 weeks of completion of primary amphotericin B therapy. Patients may receive maintenance amphotericin B during the period between completion of primary therapy and study entry. Prior Medication: Allowed: Antivirals such as zidovudine (AZT). Prophylaxis (including aerosolized pentamidine) for Pneumocystis carinii pneumonia (PCP). Exclusion Criteria Co-existing Condition: Patients with the following are excluded: Clinical evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis. History of allergy or intolerance of imidazoles, azoles, or amphotericin B. Moderate or severe liver disease. Concurrent Medication: Excluded: Ketoconazole. Fluconazole. Itraconazole. Miconazole. Any systemic imidazole or azole for more than 7 days after initiation of primary therapy for cryptococcosis. Intrathecal amphotericin B. Coumarin-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: Clinical evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis. History of allergy or intolerance of imidazoles, azoles, or amphotericin B. Moderate or severe liver disease. Inability to take oral medications reliably. Prior Medication: Excluded: Ketoconazole. Fluconazole. Itraconazole. Miconazole. Any systemic imidazole or azole for more than 7 days after initiation of primary therapy for cryptococcosis. Intrathecal amphotericin B. Coumarin-type anticoagulants. Oral hypoglycemics. Barbiturates. Phenytoin. Immunostimulants. Investigational drugs or approved (licensed) drugs for investigational indications. Any exceptions to these prohibitions of concomitant medications must be approved by Pfizer Central Research. Prior Treatment: Excluded: Lymphocyte replacement.

Sites / Locations

  • Univ of Alabama at Birmingham
  • Tucson Veterans Administration Med Ctr
  • Dr Richard Meyer
  • Davies Med Ctr
  • Dr Paul Rothman
  • Wilmington Hosp / Med Ctr of Delaware
  • George Washington Univ Med Ctr
  • Univ of Florida College of Medicine
  • Univ of South Florida
  • Emory Univ School of Medicine
  • Med College of Georgia
  • DeKalb Gen Hosp
  • Shallowford Hosp
  • Northwestern Univ Med School
  • Dr Michael Bach
  • Univ of Maryland / Inst of Human Virology
  • New England Med Ctr
  • Univ Hosp
  • Ann Arbor Veterans Administration Med Ctr
  • Harper Hosp
  • Henry Ford Hosp
  • Saint Michael's Med Ctr
  • Albany Med College / AIDS Treatment Ctr
  • Jewish Hosp Ctr Affiliation
  • Cabrini Med Ctr
  • Chelsea Village Med Ctr
  • Columbia Univ
  • Harlem AIDS Treatment Group / Harlem Hosp Ctr
  • Bowman Gray School of Medicine / North Carolina Baptist Hosp
  • Cincinnati Veterans Adm Med Ctr / Univ Hosp
  • Buckley Braffman Stern Med Associates
  • Univ TX Galveston Med Branch
  • United States Air Force Med Ctr
  • Southwest Texas Methodist Hosp
  • Univ TX San Antonio Health Science Ctr
  • Richmond AIDS Consortium
  • CHG-118 Group Health / Cooperative of Puget Sound
  • Dr Philip C Craven
  • 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
NCT00002074
Brief Title
Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Maintenance Treatment for the Prevention of Relapse of Cryptococcal Meningitis in Patients With Acquired Immunodeficiency Syndrome
Official Title
Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Maintenance Treatment for the Prevention of Relapse of Cryptococcal Meningitis in Patients With Acquired Immunodeficiency Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
May 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 as maintenance treatment for preventing the relapse of cryptococcal meningitis in patients with AIDS.

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, Fluconazole, 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
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Concurrent Medication: Allowed: Antivirals such as zidovudine. Prophylaxis (including aerosolized pentamidine) for Pneumocystis carinii pneumonia (PCP). Pfizer must be notified if the patient is receiving ganciclovir (DHPG) at entry. Concurrent Treatment: Allowed: Radiation therapy for mucocutaneous Kaposi's sarcoma. Patients must be oriented to person, place, and time, and able to give written informed consent. Patients must have had an acute episode of cryptococcal meningitis that was documented by recovery and identification of Cryptococcus neoformans from lumbar cerebrospinal fluid (CSF) culture within 6 months prior to entry. Minimum total dose of 15 mg/kg of amphotericin B must have been given (either alone or in combination with flucytosine) during primary therapy. Patients need not be receiving amphotericin B at the time of randomization but must begin study maintenance therapy within 6 weeks of completion of primary amphotericin B therapy. Patients may receive maintenance amphotericin B during the period between completion of primary therapy and study entry. Prior Medication: Allowed: Antivirals such as zidovudine (AZT). Prophylaxis (including aerosolized pentamidine) for Pneumocystis carinii pneumonia (PCP). Exclusion Criteria Co-existing Condition: Patients with the following are excluded: Clinical evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis. History of allergy or intolerance of imidazoles, azoles, or amphotericin B. Moderate or severe liver disease. Concurrent Medication: Excluded: Ketoconazole. Fluconazole. Itraconazole. Miconazole. Any systemic imidazole or azole for more than 7 days after initiation of primary therapy for cryptococcosis. Intrathecal amphotericin B. Coumarin-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: Clinical evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis. History of allergy or intolerance of imidazoles, azoles, or amphotericin B. Moderate or severe liver disease. Inability to take oral medications reliably. Prior Medication: Excluded: Ketoconazole. Fluconazole. Itraconazole. Miconazole. Any systemic imidazole or azole for more than 7 days after initiation of primary therapy for cryptococcosis. Intrathecal amphotericin B. Coumarin-type anticoagulants. Oral hypoglycemics. Barbiturates. Phenytoin. Immunostimulants. Investigational drugs or approved (licensed) drugs for investigational indications. Any exceptions to these prohibitions of concomitant medications must be approved by Pfizer Central Research. Prior Treatment: Excluded: Lymphocyte replacement.
Facility Information:
Facility Name
Univ of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Tucson Veterans Administration Med Ctr
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Dr Richard Meyer
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Davies Med Ctr
City
San Francisco
State/Province
California
ZIP/Postal Code
94114
Country
United States
Facility Name
Dr Paul Rothman
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Wilmington Hosp / Med Ctr of Delaware
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19899
Country
United States
Facility Name
George Washington Univ Med Ctr
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Univ of Florida College of Medicine
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Univ of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Emory Univ School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Med College of Georgia
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
DeKalb Gen Hosp
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Shallowford Hosp
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Northwestern Univ Med School
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Dr Michael Bach
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
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
New England Med Ctr
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Univ Hosp
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Ann Arbor Veterans Administration Med Ctr
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Facility Name
Harper Hosp
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Henry Ford Hosp
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Saint Michael's Med Ctr
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07102
Country
United States
Facility Name
Albany Med College / AIDS Treatment Ctr
City
Albany
State/Province
New York
ZIP/Postal Code
12203
Country
United States
Facility Name
Jewish Hosp Ctr Affiliation
City
Jamaica
State/Province
New York
ZIP/Postal Code
11432
Country
United States
Facility Name
Cabrini Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Chelsea Village Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10014
Country
United States
Facility Name
Columbia Univ
City
New York
State/Province
New York
ZIP/Postal Code
10032
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
Bowman Gray School of Medicine / North Carolina Baptist Hosp
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Cincinnati Veterans Adm Med Ctr / Univ Hosp
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
452670405
Country
United States
Facility Name
Buckley Braffman Stern Med Associates
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Univ TX Galveston Med Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77550
Country
United States
Facility Name
United States Air Force Med Ctr
City
Lackland Air Force Base
State/Province
Texas
ZIP/Postal Code
782365300
Country
United States
Facility Name
Southwest Texas Methodist Hosp
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Univ TX San Antonio Health Science Ctr
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78284
Country
United States
Facility Name
Richmond AIDS Consortium
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Facility Name
CHG-118 Group Health / Cooperative of Puget Sound
City
Seattle
State/Province
Washington
ZIP/Postal Code
98112
Country
United States
Facility Name
Dr Philip C Craven
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Saint Michael's Hosp
City
Toronto
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
1538722
Citation
Powderly WG, Saag MS, Cloud GA, Robinson P, Meyer RD, Jacobson JM, Graybill JR, Sugar AM, McAuliffe VJ, Follansbee SE, et al. A controlled trial of fluconazole or amphotericin B to prevent relapse of cryptococcal meningitis in patients with the acquired immunodeficiency syndrome. The NIAID AIDS Clinical Trials Group and Mycoses Study Group. N Engl J Med. 1992 Mar 19;326(12):793-8. doi: 10.1056/NEJM199203193261203.
Results Reference
background
PubMed Identifier
1727236
Citation
Saag MS, Powderly WG, Cloud GA, Robinson P, Grieco MH, Sharkey PK, Thompson SE, Sugar AM, Tuazon CU, Fisher JF, et al. Comparison of amphotericin B with fluconazole in the treatment of acute AIDS-associated cryptococcal meningitis. The NIAID Mycoses Study Group and the AIDS Clinical Trials Group. N Engl J Med. 1992 Jan 9;326(2):83-9. doi: 10.1056/NEJM199201093260202.
Results Reference
background

Learn more about this trial

Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Maintenance Treatment for the Prevention of Relapse of Cryptococcal Meningitis in Patients With Acquired Immunodeficiency Syndrome

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