A Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis
This study has been completed.
Sponsor:
Pfizer
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002068
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: February 1990
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To compare the safety and effectiveness of fluconazole and amphotericin B, alone or in combination with flucytosine, as treatment for acute cryptococcal meningitis.
Condition | Intervention |
---|---|
Meningitis, Cryptococcal HIV Infections |
Drug: Fluconazole Drug: Amphotericin B |
Study Type: | Interventional |
Study Design: | Primary Purpose: Treatment |
Official Title: | A Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis |
Resource links provided by NLM:
Further study details as provided by NIH AIDS Clinical Trials Information Service:
![](https://webarchive.library.unt.edu/web/20130312224319im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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.
Concurrent Medication:
Excluded within 4 weeks of study entry:
- Greater than 1 mg/kg/wk amphotericin B.
- Coumadin-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:
- 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 within 4 weeks of study entry:
- Greater than 1 mg/kg/wk amphotericin B.
- Coumadin-type anticoagulants.
- Oral hypoglycemics.
- Barbiturates.
- Phenytoin.
- Immunostimulants.
- Investigational drugs or approved (licensed) drugs for investigational indications.
Prior Treatment:
Excluded:
- Lymphocyte replacement.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00002068
Locations
United States, California | |
Davies Med Ctr | |
San Francisco, California, United States, 94114 | |
United States, Delaware | |
Christiana Hosp / Med Ctr of Delaware | |
Wilmington, Delaware, United States, 19899 | |
United States, Florida | |
Univ of South Florida | |
Tampa, Florida, United States, 33612 | |
United States, Maryland | |
Univ of Maryland / Inst of Human Virology | |
Baltimore, Maryland, United States, 212011192 | |
United States, Michigan | |
Henry Ford Hosp | |
Detroit, Michigan, United States, 48202 | |
United States, New York | |
Harlem AIDS Treatment Group / Harlem Hosp Ctr | |
New York, New York, United States, 10037 | |
United States, Tennessee | |
Univ of Tennessee | |
Memphis, Tennessee, United States, 38163 | |
Canada, Ontario | |
Saint Michael's Hosp | |
Toronto, Ontario, Canada |
Sponsors and Collaborators
Pfizer
![](https://webarchive.library.unt.edu/web/20130312224319im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
No publications provided
ClinicalTrials.gov Identifier: | NCT00002068 History of Changes |
Other Study ID Numbers: | 012H, 056-159B |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
Health Authority: | United States: Food and Drug Administration |
Keywords provided by NIH AIDS Clinical Trials Information Service:
AIDS-Related Opportunistic Infections Meningitis Cryptococcosis Drug Therapy, Combination |
Fluconazole Flucytosine Acquired Immunodeficiency Syndrome Amphotericin B |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Meningitis Meningitis, Cryptococcal Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Central Nervous System Infections Central Nervous System Diseases |
Nervous System Diseases Meningitis, Fungal Central Nervous System Fungal Infections Mycoses Cryptococcosis Amphotericin B Liposomal amphotericin B Fluconazole Amebicides Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antifungal Agents |
ClinicalTrials.gov processed this record on March 10, 2013