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Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis


N/A
18 Years
N/A
Not Enrolling
Both
Meningitis, Cryptococcal, HIV Infections

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Trial Information

Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis

Inclusion Criteria


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.

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

012F

NCT ID:

NCT00002305

Start Date:

Completion Date:

Related Keywords:

  • Meningitis, Cryptococcal
  • HIV Infections
  • AIDS-Related Opportunistic Infections
  • Meningitis
  • Cryptococcosis
  • Drug Therapy, Combination
  • Fluconazole
  • Flucytosine
  • Acquired Immunodeficiency Syndrome
  • Amphotericin B
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Meningitis
  • Meningitis, Cryptococcal

Name

Location

Mem Sloan - Kettering Cancer Ctr New York, New York  10021
Saint Luke's - Roosevelt Hosp Ctr New York, New York  10025
UCLA CARE Ctr Los Angeles, California  90095
George Washington Univ Med Ctr Washington, District of Columbia  20037
Univ of Miami School of Medicine Miami, Florida  331361013
Northwestern Univ Med School Chicago, Illinois  60611
Tulane Univ School of Medicine New Orleans, Louisiana  70112
Bronx Veterans Administration / Mount Sinai Hosp Bronx, New York  10468
Montefiore Med Ctr / Bronx Municipal Hosp Bronx, New York  10467
Univ of South Florida Tampa, Florida  33612
Univ TX Galveston Med Branch Galveston, Texas  77550
Univ of Alabama at Birmingham Birmingham, Alabama  35294
Henry Ford Hosp Detroit, Michigan  48202
Harlem AIDS Treatment Group / Harlem Hosp Ctr New York, New York  10037
Richmond AIDS Consortium Richmond, Virginia  23298
Med College of Georgia Augusta, Georgia  30912
Univ TX San Antonio Health Science Ctr San Antonio, Texas  782847881
Louisiana State Univ School of Medicine New Orleans, Louisiana  70112
Chelsea Village Med Ctr New York, New York  10014
Univ of Tennessee Memphis, Tennessee  38163
Univ of North Carolina School of Medicine Chapel Hill, North Carolina  275997215
Albany Med College / AIDS Treatment Ctr Albany, New York  12203
Tucson Veterans Administration Med Ctr Tucson, Arizona  85724
Dr Shelly Gordon San Francisco, California  94115
Dr Martin Mass San Francisco, California  94120
Dr Paul Rothman Sherman Oaks, California  91403
Christiana Hosp / Med Ctr of Delaware Wilmington, Delaware  19899
Emory Univ School of Medicine Atlanta, Georgia  30303
DeKalb Gen Hosp Decatur, Georgia  30033
Dr Michael Bach Portland, Maine  04102
Loch Raven Veterans Hosp Baltimore, Maryland  21218
Univ of Maryland / Inst of Human Virology Baltimore, Maryland  212011192
New England Med Ctr Boston, Massachusetts  02111
Univ Hosp Boston, Massachusetts  02118
Ann Arbor Veterans Administration Med Ctr Ann Arbor, Michigan  48105
Harper Hosp Detroit, Michigan  48201
Washington Univ School of Medicine St. Louis, Missouri  63108
Jewish Hosp Ctr Affiliation Jamaica, New York  11432
Columbia Univ New York, New York  10032
Cincinnati Veterans Adm Med Ctr / Univ Hosp Cincinnati, Ohio  452670405
Ohio State Univ Hosp Columbus, Ohio  43210
Dr Daniel Barbaro Dallas, Texas  75235
United States Air Force Med Ctr Lackland Air Force Base, Texas  782365300
CHG-118 Group Health / Cooperative of Puget Sound Seattle, Washington  98112