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

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00002074

Collaborator

(none)

Locations

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Meningitis, Cryptococcal HIV Infections	Drug: Fluconazole Drug: Amphotericin B	N/A

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Univ of Alabama at Birmingham	Birmingham	Alabama	United States	35294
2	Tucson Veterans Administration Med Ctr	Tucson	Arizona	United States	85724
3	Dr Richard Meyer	Los Angeles	California	United States	90048
4	Davies Med Ctr	San Francisco	California	United States	94114
5	Dr Paul Rothman	Sherman Oaks	California	United States	91403
6	Wilmington Hosp / Med Ctr of Delaware	Wilmington	Delaware	United States	19899
7	George Washington Univ Med Ctr	Washington	District of Columbia	United States	20037
8	Univ of Florida College of Medicine	Gainesville	Florida	United States	32610
9	Univ of South Florida	Tampa	Florida	United States	33612
10	Emory Univ School of Medicine	Atlanta	Georgia	United States	30303
11	Med College of Georgia	Augusta	Georgia	United States	30912
12	DeKalb Gen Hosp	Decatur	Georgia	United States	30033
13	Shallowford Hosp	Decatur	Georgia	United States	30033
14	Northwestern Univ Med School	Chicago	Illinois	United States	60611
15	Dr Michael Bach	Portland	Maine	United States	04102
16	Univ of Maryland / Inst of Human Virology	Baltimore	Maryland	United States	212011192
17	New England Med Ctr	Boston	Massachusetts	United States	02111
18	Univ Hosp	Boston	Massachusetts	United States	02118
19	Ann Arbor Veterans Administration Med Ctr	Ann Arbor	Michigan	United States	48105
20	Harper Hosp	Detroit	Michigan	United States	48201
21	Henry Ford Hosp	Detroit	Michigan	United States	48202
22	Saint Michael's Med Ctr	Newark	New Jersey	United States	07102
23	Albany Med College / AIDS Treatment Ctr	Albany	New York	United States	12203
24	Jewish Hosp Ctr Affiliation	Jamaica	New York	United States	11432
25	Cabrini Med Ctr	New York	New York	United States	10003
26	Chelsea Village Med Ctr	New York	New York	United States	10014
27	Columbia Univ	New York	New York	United States	10032
28	Harlem AIDS Treatment Group / Harlem Hosp Ctr	New York	New York	United States	10037
29	Bowman Gray School of Medicine / North Carolina Baptist Hosp	Winston-Salem	North Carolina	United States	27103
30	Cincinnati Veterans Adm Med Ctr / Univ Hosp	Cincinnati	Ohio	United States	452670405
31	Buckley Braffman Stern Med Associates	Philadelphia	Pennsylvania	United States	19107
32	Univ TX Galveston Med Branch	Galveston	Texas	United States	77550
33	United States Air Force Med Ctr	Lackland Air Force Base	Texas	United States	782365300
34	Southwest Texas Methodist Hosp	San Antonio	Texas	United States	78229
35	Univ TX San Antonio Health Science Ctr	San Antonio	Texas	United States	78284
36	Richmond AIDS Consortium	Richmond	Virginia	United States	23219
37	CHG-118 Group Health / Cooperative of Puget Sound	Seattle	Washington	United States	98112
38	Dr Philip C Craven	Tacoma	Washington	United States	98405
39	Saint Michael's Hosp	Toronto	Ontario	Canada