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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002074
• Other study ID #: 012D
• Secondary ID: 056-157
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: May 1990
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Immunologic Deficiency Syndromes
• Meningitis
• Meningitis, Cryptococcal

Intervention

Drug:
• Fluconazole

• Amphotericin B

Locations

Country	Name	City	State
Canada	Saint Michael's Hosp	Toronto	Ontario
United States	Albany Med College / AIDS Treatment Ctr	Albany	New York
United States	Ann Arbor Veterans Administration Med Ctr	Ann Arbor	Michigan
United States	Emory Univ School of Medicine	Atlanta	Georgia
United States	Med College of Georgia	Augusta	Georgia
United States	Univ of Maryland / Inst of Human Virology	Baltimore	Maryland
United States	Univ of Alabama at Birmingham	Birmingham	Alabama
United States	New England Med Ctr	Boston	Massachusetts
United States	Univ Hosp	Boston	Massachusetts
United States	Northwestern Univ Med School	Chicago	Illinois
United States	Cincinnati Veterans Adm Med Ctr / Univ Hosp	Cincinnati	Ohio
United States	DeKalb Gen Hosp	Decatur	Georgia
United States	Shallowford Hosp	Decatur	Georgia
United States	Harper Hosp	Detroit	Michigan
United States	Henry Ford Hosp	Detroit	Michigan
United States	Univ of Florida College of Medicine	Gainesville	Florida
United States	Univ TX Galveston Med Branch	Galveston	Texas
United States	Jewish Hosp Ctr Affiliation	Jamaica	New York
United States	United States Air Force Med Ctr	Lackland Air Force Base	Texas
United States	Dr Richard Meyer	Los Angeles	California
United States	Cabrini Med Ctr	New York	New York
United States	Chelsea Village Med Ctr	New York	New York
United States	Columbia Univ	New York	New York
United States	Harlem AIDS Treatment Group / Harlem Hosp Ctr	New York	New York
United States	Saint Michael's Med Ctr	Newark	New Jersey
United States	Buckley Braffman Stern Med Associates	Philadelphia	Pennsylvania
United States	Dr Michael Bach	Portland	Maine
United States	Richmond AIDS Consortium	Richmond	Virginia
United States	Southwest Texas Methodist Hosp	San Antonio	Texas
United States	Univ TX San Antonio Health Science Ctr	San Antonio	Texas
United States	Davies Med Ctr	San Francisco	California
United States	CHG-118 Group Health / Cooperative of Puget Sound	Seattle	Washington
United States	Dr Paul Rothman	Sherman Oaks	California
United States	Dr Philip C Craven	Tacoma	Washington
United States	Univ of South Florida	Tampa	Florida
United States	Tucson Veterans Administration Med Ctr	Tucson	Arizona
United States	George Washington Univ Med Ctr	Washington	District of Columbia
United States	Wilmington Hosp / Med Ctr of Delaware	Wilmington	Delaware
United States	Bowman Gray School of Medicine / North Carolina Baptist Hosp	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (2)

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. — View 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. — View Citation