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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 CtrNew York, New York  10021
Saint Luke's - Roosevelt Hosp CtrNew York, New York  10025
UCLA CARE CtrLos Angeles, California  90095
George Washington Univ Med CtrWashington, District of Columbia  20037
Univ of Miami School of MedicineMiami, Florida  331361013
Northwestern Univ Med SchoolChicago, Illinois  60611
Tulane Univ School of MedicineNew Orleans, Louisiana  70112
Bronx Veterans Administration / Mount Sinai HospBronx, New York  10468
Montefiore Med Ctr / Bronx Municipal HospBronx, New York  10467
Univ of South FloridaTampa, Florida  33612
Univ TX Galveston Med BranchGalveston, Texas  77550
Univ of Alabama at BirminghamBirmingham, Alabama  35294
Henry Ford HospDetroit, Michigan  48202
Harlem AIDS Treatment Group / Harlem Hosp CtrNew York, New York  10037
Richmond AIDS ConsortiumRichmond, Virginia  23298
Med College of GeorgiaAugusta, Georgia  30912
Univ TX San Antonio Health Science CtrSan Antonio, Texas  782847881
Louisiana State Univ School of MedicineNew Orleans, Louisiana  70112
Chelsea Village Med CtrNew York, New York  10014
Univ of TennesseeMemphis, Tennessee  38163
Univ of North Carolina School of MedicineChapel Hill, North Carolina  275997215
Albany Med College / AIDS Treatment CtrAlbany, New York  12203
Tucson Veterans Administration Med CtrTucson, Arizona  85724
Dr Shelly GordonSan Francisco, California  94115
Dr Martin MassSan Francisco, California  94120
Dr Paul RothmanSherman Oaks, California  91403
Christiana Hosp / Med Ctr of DelawareWilmington, Delaware  19899
Emory Univ School of MedicineAtlanta, Georgia  30303
DeKalb Gen HospDecatur, Georgia  30033
Dr Michael BachPortland, Maine  04102
Loch Raven Veterans HospBaltimore, Maryland  21218
Univ of Maryland / Inst of Human VirologyBaltimore, Maryland  212011192
New England Med CtrBoston, Massachusetts  02111
Univ HospBoston, Massachusetts  02118
Ann Arbor Veterans Administration Med CtrAnn Arbor, Michigan  48105
Harper HospDetroit, Michigan  48201
Washington Univ School of MedicineSt. Louis, Missouri  63108
Jewish Hosp Ctr AffiliationJamaica, New York  11432
Columbia UnivNew York, New York  10032
Cincinnati Veterans Adm Med Ctr / Univ HospCincinnati, Ohio  452670405
Ohio State Univ HospColumbus, Ohio  43210
Dr Daniel BarbaroDallas, Texas  75235
United States Air Force Med CtrLackland Air Force Base, Texas  782365300
CHG-118 Group Health / Cooperative of Puget SoundSeattle, Washington  98112