Clinical trial NCT00002074: 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
Overall status: COMPLETED
Phase: NA
Conditions: Meningitis, Cryptococcal
HIV Infections
Keywords: AIDS-Related Opportunistic Infections
Meningitis
Cryptococcosis
Fluconazole
Acquired Immunodeficiency Syndrome
Amphotericin B
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.


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.

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