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Trial NCT00000639

Resource URI: http://static.linkedct.org/resource/trials/NCT00000639
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linkedct:brief_title 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
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linkedct:criteria Inclusion Criteria Concurrent Medication: Allowed: - Interruption of myelosuppressive therapies and/or administration of erythropoietin, at discretion of investigator, to maintain hemoglobin = or > 7 g/dl. - Adjunctive corticosteroids may be administered during the triazole phase for patients who develop Pneumocystis carinii pneumonia and meet the prescribed criteria. - Hydrocortisone, not to exceed 50 mg/day, during the amphotericin phase. - Aerosolized pentamidine or systemic chemoprophylaxis for Pneumocystis carinii pneumonia should be given to all patients with a CD4 count < 200 cells/mm3. - Antiretroviral drugs (including zidovudine (AZT), didanosine (ddI), dideoxycytidine (ddC)) after patient has tolerated oral triazole for one week (after 3 weeks of study treatment). - Maintenance treatment (except for rifamycins) for other opportunistic infections such as cytomegalovirus (CMV) retinitis, cerebral toxoplasmosis or mycobacterial infections, provided that their hematologic and hepatic values are stable and they meet the entry criteria. Concurrent Treatment: Allowed: - Transfusion, at discretion of investigator, to maintain hemoglobin = or > 7 g/dl. Patients must have: - HIV infection. - Primary episode of acute cryptococcal meningitis. - Willing to participate in the study for a full 10 weeks and either be able to give informed consent or have a family member or guardian able to give informed consent. Prior Medication: Allowed: Fluconazole prophylaxis, not exceeding 200 mg/day. Risk Behavior: Allowed: - History of high-risk behavior for HIV infection (bisexual or homosexual men, intravenous drug abusers) and their sexual partners. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: - Inability to take oral medication (if necessary, flucytosine and flucytosine placebo may be administered via nasogastric tube during the amphotericin phase). - History of hypersensitivity to imidazole or triazole compounds. - Active hepatitis (viral, drug-induced, or other) defined by progressive worsening of hepatic enzymes to grade 3 or 4 toxicity on at least two occasions. - Comatose. - Concurrent CNS disease which, in the opinion of the investigator, would interfere with assessment of response. Concurrent Medication: Excluded: - Continued treatment with H2 blockers (ranitidine (Zantac), cimetidine (Tagamet), omeprazole (Prilosec), nizatidine (Axid), famotidine (Pepcid)). - Antacids and didanosine (ddI) within 2 hours of triazole administration. - Rifampin, rifabutin (Ansamycin), and other rifamycin derivatives, phenytoin (Dilantin), phenobarbital, or carbamazepine (Tegretol). - Other systemic antifungal agents. Prior Medication: Excluded: - Amphotericin, > 1 mg/kg, or fluconazole or ketoconazole, > 1200 mg, as prior treatment for current primary episode of acute cryptococcal meningitis or treatment started for this episode more than 72 hours prior to enrollment into study. - Phenytoin (Dilantin), carbamazepine (Tegretol), phenobarbital, rifabutin (Ansamycin), rifampin or other rifamycins within the last 15 days. Patients may not have: - Inability to take oral medication (if necessary, flucytosine and flucytosine placebo may be administered via nasogastric tube during the amphotericin phase). - History of hypersensitivity to imidazole or triazole compounds. - Active hepatitis. - Patients who are comatose. - Concurrent CNS disease which, in the opinion of the investigator, would interfere with assessment of response.
linkedct:description At least 10 percent of patients with a low CD4 count and HIV infection will develop meningitis due to Cryptococcus neoformans. More effective treatments than the standard therapy need to be explored. Patients are selected by a randomization process to take amphotericin B intravenously (in the vein), for 14 days, and either placebo (ineffective substance) or flucytosine for 14 days. Then patients are again selected by a randomization process to take either (1) fluconazole for a total of 8 weeks plus itraconazole placebo; or (2) itraconazole for a total of 8 weeks plus fluconazole placebo.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age N/A
linkedct:eligibility_minimum_age 13 Years
linkedct:enrollment 400 (xsd:int)
linkedct:firstreceived_date November 2, 1999
linkedct:id NCT00000639
rdfs:label Trial NCT00000639
linkedct:lastchanged_date August 22, 2008
linkedct:lead_sponsor_agency Washington University School of Medicine
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linkedct:nct_id NCT00000639
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linkedct:official_title 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
linkedct:org_study_id ACTG 159
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linkedct:overall_official <http://static.linkedct.org/resource/overall_official/59845>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000639>
linkedct:phase N/A
linkedct:reference <http://static.linkedct.org/resource/reference/2781>
linkedct:reference <http://static.linkedct.org/resource/reference/50255>
linkedct:reference <http://static.linkedct.org/resource/reference/52505>
linkedct:secondary_id FDA 235A
linkedct:secondary_id MSG Study 17
linkedct:source National Institute of Allergy and Infectious Diseases (NIAID)
linkedct:study_design Treatment, Double-Blind, Safety Study
linkedct:study_type Interventional
linkedct:summary To evaluate the effectiveness and safety of amphotericin B plus flucytosine (5-fluorocytosine) compared to amphotericin B alone for a first episode of acute cryptococcal meningitis in AIDS patients, and to compare the effectiveness and safety of fluconazole versus itraconazole. At least 10 percent of patients with a low CD4 count and HIV infection will develop meningitis due to Cryptococcus neoformans. More effective treatments than the standard therapy need to be explored.
rdf:type linkedct:trials
linkedct:verification_date September 1994