A Comparison of Fluconazole and Amphotericin B in the Treatment of Cryptococcal Meningitis

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00002305

Collaborator

(none)

Locations

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Meningitis, Cryptococcal HIV Infections	Drug: Flucytosine 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 Treatment for Acute Cryptococcal Meningitis

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 0 Years

Sexes Eligible for Study:

All

Accepts 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.
Any exceptions to these prohibitions of concomitant medications must be approved by Pfizer Central Research.

Concurrent Medication:

Excluded:

Coumadin-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.
Excluded within 4 weeks of study entry:
Greater than 1 mg/kg/wk amphotericin B.

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:

Coumadin-type anticoagulants.
Oral hypoglycemics.
Barbiturates.
Phenytoin.
Immunostimulants.
Investigational drugs or approved (licensed) drugs for investigational indications.
Excluded within 4 weeks of study entry:
Greater than 1 mg/kg/wk amphotericin B.

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	UCLA CARE Ctr	Los Angeles	California	United States	90095
4	Dr Shelly Gordon	San Francisco	California	United States	94115
5	Dr Martin Mass	San Francisco	California	United States	94120
6	Dr Paul Rothman	Sherman Oaks	California	United States	91403
7	Christiana Hosp / Med Ctr of Delaware	Wilmington	Delaware	United States	19899
8	George Washington Univ Med Ctr	Washington	District of Columbia	United States	20037
9	Univ of Miami School of Medicine	Miami	Florida	United States	331361013
10	Univ of South Florida	Tampa	Florida	United States	33612
11	Emory Univ School of Medicine	Atlanta	Georgia	United States	30303
12	Med College of Georgia	Augusta	Georgia	United States	30912
13	DeKalb Gen Hosp	Decatur	Georgia	United States	30033
14	Northwestern Univ Med School	Chicago	Illinois	United States	60611
15	Louisiana State Univ School of Medicine	New Orleans	Louisiana	United States	70112
16	Tulane Univ School of Medicine	New Orleans	Louisiana	United States	70112
17	Dr Michael Bach	Portland	Maine	United States	04102
18	Univ of Maryland / Inst of Human Virology	Baltimore	Maryland	United States	212011192
19	Loch Raven Veterans Hosp	Baltimore	Maryland	United States	21218
20	New England Med Ctr	Boston	Massachusetts	United States	02111
21	Univ Hosp	Boston	Massachusetts	United States	02118
22	Ann Arbor Veterans Administration Med Ctr	Ann Arbor	Michigan	United States	48105
23	Harper Hosp	Detroit	Michigan	United States	48201
24	Henry Ford Hosp	Detroit	Michigan	United States	48202
25	Washington Univ School of Medicine	St. Louis	Missouri	United States	63108
26	Albany Med College / AIDS Treatment Ctr	Albany	New York	United States	12203
27	Montefiore Med Ctr / Bronx Municipal Hosp	Bronx	New York	United States	10467
28	Bronx Veterans Administration / Mount Sinai Hosp	Bronx	New York	United States	10468
29	Jewish Hosp Ctr Affiliation	Jamaica	New York	United States	11432
30	Chelsea Village Med Ctr	New York	New York	United States	10014
31	Mem Sloan - Kettering Cancer Ctr	New York	New York	United States	10021
32	Saint Luke's - Roosevelt Hosp Ctr	New York	New York	United States	10025
33	Columbia Univ	New York	New York	United States	10032
34	Harlem AIDS Treatment Group / Harlem Hosp Ctr	New York	New York	United States	10037
35	Univ of North Carolina School of Medicine	Chapel Hill	North Carolina	United States	275997215
36	Cincinnati Veterans Adm Med Ctr / Univ Hosp	Cincinnati	Ohio	United States	452670405
37	Ohio State Univ Hosp	Columbus	Ohio	United States	43210
38	Univ of Tennessee	Memphis	Tennessee	United States	38163
39	Dr Daniel Barbaro	Dallas	Texas	United States	75235
40	Univ TX Galveston Med Branch	Galveston	Texas	United States	77550
41	United States Air Force Med Ctr	Lackland Air Force Base	Texas	United States	782365300
42	Univ TX San Antonio Health Science Ctr	San Antonio	Texas	United States	78284
43	Richmond AIDS Consortium	Richmond	Virginia	United States	23219
44	CHG-118 Group Health / Cooperative of Puget Sound	Seattle	Washington	United States	98112
45	Saint Michael's Hosp	Toronto	Ontario	Canada