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Home > "O" Clinical Trials Conditions > Open, Non-Comparative Study of Intravenous and Oral Fluconazole in the Treatment of Acute Cryptococcal Meningitis  Open, Non-Comparative Study of Intravenous and Oral Fluconazole in the Treatment of Acute Cryptococcal Meningitis
Open, Non-Comparative Study of Intravenous and Oral Fluconazole in the Treatment of Acute Cryptococcal Meningitis
For Condition: Meningitis, Cryptococcal,HIV Infections
Status: Completed
Sponsor(s): Pfizer ,
Synopsis: To evaluate the safety and effectiveness of fluconazole as an intravenous dose as initial treatment for acute cryptococcal meningitis followed by oral therapy in AIDS and non-AIDS patients. Both newly diagnosed and relapsed patients are eligible. The effectiveness of maintenance fluconazole therapy in sustaining a clinical cure in AIDS patients will also be evaluated.
Details:
Eligibility:
Study Type: Interventional, Treatment, Open Label
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Antivirals such as zidovudine. Prophylaxis for Pneumocystis carinii pneumonia. Aerosolized pentamidine. 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. - Patient's treatment status must be one of the following: - No prior systemic antifungal therapy for cryptococcosis. - Relapse after prior therapy. The success of prior therapy must have been documented by negative 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 the study. Prior Medication: Allowed: - Antivirals such as zidovudine (AZT). Prophylaxis for Pneumocystis carinii pneumonia. Aerosolized pentamidine. Exclusion Criteria Co-existing Condition: Patients with the following are excluded: - Evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis. - A history of allergy to or intolerance of imidazoles or azoles. - Moderate or severe liver disease defined by specified lab values. - Life expectancy of < 2 weeks. Concurrent Medication: Excluded: - Coumarin-type anticoagulants. - Oral hypoglycemics. - Barbiturates. - Phenytoin. - Immunostimulants. - Investigational drugs or approved (licensed) drugs for investigational indications except aerosolized pentamidine. Concurrent Treatment: Excluded: - Lymphocyte replacement. Patients with the following are excluded: - Evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis. - A history of allergy to or intolerance of imidazoles or azoles. - Moderate or severe liver disease defined by specified lab values. - Life expectancy of < 2 weeks. Prior Medication: Excluded: - Coumarin-type anticoagulants. - Oral hypoglycemics. - Barbiturates. - Phenytoin. - Immunostimulants. - Investigational drugs or approved (licensed) drugs for investigational indications except aerosolized pentamidine. Prior Treatment: Excluded: - Lymphocyte replacement.
Total Enrollment:
Location and Contact Information:
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, 19107
United States
Cornell Univ Med Ctr
New York City, New York, 10021
United States
Cook County Hosp
Chicago, Illinois, 60612
United States
SUNY / Health Sciences Ctr at Brooklyn
Brooklyn, New York, 11203
United States
Summitt Med Ctr / San Francisco Gen Hosp
Oakland, California, 94609
United States
Additional Information:
Study ID Numbers: 012L; 056-164A
Study Start Date:
Record last reviewed: February 1990
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002040
Other Hiv Infections Studies:
1. A Study of Fluconazole in the Treatment of Cryptococcal Meningitis in Patients with AIDS
2. Open, Non-Comparative Study of Intravenous and Oral Fluconazole in the Treatment of Acute Cryptococcal Meningitis
3. A Randomized Double Blind Protocol Comparing Amphotericin B With Flucytosine to Amphotericin B Alone Followed by a Comparison of Fluconazole and Itraconazole in the Treatment of Acute Cryptococcal Meningitis
4. 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
5. A Pilot Study of Fluconazole Plus Flucytosine for the Treatment of AIDS Patients With Acute Cryptococcal Meningitis.
Related Studies:
Other HIV Infections Clinical Trials
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Other Oakland Clinical Trials
Open, Non-Comparative Study of Intravenous and Oral Fluconazole in the Treatment of Acute Cryptococcal Meningitis
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