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An Open, Non-Comparative Study of Intravenous and Oral Fluconazole in the Treatment of Acute Cryptococcal Meningitis Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about An Open, Non-Comparative Study of Intravenous and Oral Fluconazole in the Treatment of Acute Cryptococcal Meningitis conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. An Open, Non-Comparative Study of Intravenous and Oral Fluconazole in the Treatment of Acute Cryptococcal Meningitis Clinical research trials and An Open, Non-Comparative Study of Intravenous and Oral Fluconazole in the Treatment of Acute Cryptococcal Meningitis health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including An Open, Non-Comparative Study of Intravenous and Oral Fluconazole in the Treatment of Acute Cryptococcal Meningitis. An Open, Non-Comparative Study of Intravenous and Oral Fluconazole in the Treatment of Acute Cryptococcal Meningitis Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a An Open, Non-Comparative Study of Intravenous and Oral Fluconazole in the Treatment of Acute Cryptococcal Meningitis clinical trial. Test subjects typically receive the most expert healthcare available for their An Open, Non-Comparative Study of Intravenous and Oral Fluconazole in the Treatment of Acute Cryptococcal Meningitis condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > An Open, Non-Comparative Study of Intravenous and Oral Fluconazole in the Treatment of Acute Cryptococcal Meningitis  An Open, Non-Comparative Study of Intravenous and Oral Fluconazole in the Treatment of Acute Cryptococcal Meningitis
An 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. Lack of satisfactory response will allow increase of dose. Both newly diagnosed and relapsed patients are eligible.
Details:
Eligibility:
Study Type: Interventional, Treatment, Open Label
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Antivirals such as zidovudine (AZT). - Prophylaxis for Pneumocystis carinii pneumonia (including 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 (including 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 other than 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 other than aerosolized pentamidine. Prior Treatment: Excluded: - Lymphocyte replacement.
Total Enrollment:
Location and Contact Information:
Saint Michael's Med Ctr
Newark, New Jersey, 07102
United States
SUNY / Health Sciences Ctr at Brooklyn
Brooklyn, New York, 11203
United States
Cabrini Med Ctr
New York City, New York, 10003
United States
Cook County Hosp
Chicago, Illinois, 60612
United States
Additional Information:
Study ID Numbers: 012K; 056-164
Study Start Date:
Record last reviewed: December 1989
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002077
Other Meningitis, Cryptococcal Studies:
1. A Comparison of Fluconazole and Amphotericin B in the Treatment of Cryptococcal Meningitis
2. Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis
3. Safety and Antifungal Activity of Recombinant Interferon-gamma 1b (rIFN-gamma 1b) Given with Standard Therapy in Patients with Cryptococcal Meningitis
4. A Study of Fluconazole in the Treatment of Cryptococcal Meningitis in Patients Who Have Not Had Success with Amphotericin B
5. An Open, Non-Comparative Study of Intravenous and Oral Fluconazole in the Treatment of Acute Cryptococcal Meningitis
Related Studies:
Other Meningitis, Cryptococcal Clinical Trials
Other New York Clinical Trials
Other Brooklyn Clinical Trials
An Open, Non-Comparative Study of Intravenous and Oral Fluconazole in the Treatment of Acute Cryptococcal Meningitis
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