|
Open, Non-Comparative Study of Intravenous and Oral Fluconazole in the Treatment of Acute Cryptococcal Meningitis Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Open, Non-Comparative Study of Intravenous and Oral Fluconazole in the Treatment of Acute Cryptococcal Meningitis conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Open, Non-Comparative Study of Intravenous and Oral Fluconazole in the Treatment of Acute Cryptococcal Meningitis Clinical research trials and Open, Non-Comparative Study of Intravenous and Oral Fluconazole in the Treatment of Acute Cryptococcal Meningitis medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as 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 Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Open, Non-Comparative Study of Intravenous and Oral Fluconazole in the Treatment of Acute Cryptococcal Meningitis clinical trial. Participants frequently get the best healthcare available for their Open, Non-Comparative Study of Intravenous and Oral Fluconazole in the Treatment of Acute Cryptococcal Meningitis condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
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 Meningitis, Cryptococcal Studies:
1. A Study of AZT in HIV-Infected Patients with AIDS-Related Kaposi's Sarcoma
2. A Comparative Trial of Valacyclovir Hydrochloride ( 256U87 ) and Acyclovir for the Suppression of Anogenital Herpes Infections in HIV-Infected Patients
3. A Study of Ganciclovir in the Treatment of Cytomegalovirus of the Eyes
4. Study of Women Who Have AIDS
5. A Multicenter Phase II/III, Placebo-Controlled Study of SNX-111 Administered Intrathecally to Cancer and AIDS Patients With Chronic Pain
Related Studies:
Other Meningitis, Cryptococcal Clinical Trials
Other Pennsylvania Clinical Trials
Other Philadelphia Clinical Trials
Open, Non-Comparative Study of Intravenous and Oral Fluconazole in the Treatment of Acute Cryptococcal Meningitis
|
|
|
|
|
|
|
|
