ISRCTN97524945已完成未知
A randomized, open-label, comparative study of the effectiveness of itraconazole versus amphotericin B in the induction treatment of penicilliosis in HIV-infected adults
niversity of Oxford (UK)0 个研究点目标入组 440 人开始时间: 2011年12月19日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 440
研究概览
简要总结
- 2017 results in https://www.nejm.org/doi/full/10.1056/NEJMoa1613306 (added 23/01/2019)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 15/02/2012
- •1. HIV positive
- •2. Age =18 years
- •3. Syndrome consistent with penicilliosis (primary or relapse) PLUS culture-confirmed diagnosis of penicilliosis (from blood, skin lesion scrapping, lymph node or bone marrow biopsy).
- •Previous inclusion criteria
- •1. HIV positive
- •2. Age = 15 years
- •3. Male and female participants
- •4. Syndrome consistent with penicilliosis (fever, malaise, hepatosplenomegaly, lymphadenopathy, typical skin lesions) plus culture confirmed diagnosis of penicilliosis (from blood, skin lesion scrapping/biopsy, lymph node or bone marrow biopsy)
排除标准
- •Current exclusion criteria as of 25/07/2013:
- •1. Age <18
- •2. Pregnancy or urine ß-hCG positive
- •3. History of allergy or severe reaction to either itraconazole or amphotericin B
- •4. Central nervous system involvement (assessed clinically and by evidence of inflammation and/or infection in the CSF)
- •5. Use of the following prohibited drugs: phenytoin, barbiturates, carbamazepine, rifampin, HMG-CoA reductase inhibitors, cisapride, terfenadine, midazolam, dihydropyridine Ca channel blocker, cyclosporine, cyclophosphamide, tacrolimus, digoxin, quinidine, ergot derivatives, pimozide, coumadin, or investigational drugs.
- •6. Baseline AST or ALT =400 U/L
- •7. Absolute neutrophil count <500 cells/µL
- •8. Creatinine clearance of <30 by Cockcroft-Gault formula or on hemodialysis
- •9. Concurrent diagnosis of cryptococcal meningitis or active tuberculosis (as amphotericin B is the treatment of choice for cryptococcal meningitis, and tuberculosis treatment with INH and rifampin is contraindicated when used with itraconazole)
- •10. Current treatment with an antifungal drug for confirmed or suspected penicilliosis for >48 hours
- •Previous exclusion criteria (15/02/2012 to 25/07/2013):
- •1. Age <18
- •2. Pregnancy or urine ß-hCG positive
- •3. History of allergy or severe reaction to either itraconazole or amphotericin B
- •4. Central nervous system involvement (assessed clinically and by evidence of inflammation and/or infection in the CSF)
- •5. Use of the following prohibited drugs: phenytoin, barbiturates, carbamazepine, rifampin, isoniazid, H2 blocker, HMG-CoA reductase inhibitors, cisapride, terfenadine, midazolam, dihydropyridine Ca channel blocker, cyclosporine, cyclophosphamide, tacrolimus, digoxin, quinidine, ergot derivatives, pimozide, coumadin, or investigational drugs.
- •6. Baseline AST or ALT =10 times the upper limit of normal
- •7. Absolute neutrophil count < 500 cells/µL
- •8. Creatinine clearance of <10 by Cockcroft-Gault formula or on hemodialysis
- •9. Concurrent diagnosis of cryptococcal meningitis or active tuberculosis (as amphotericin B is the treatment of choice for cryptococcal meningitis, and tuberculosis treatment with INH and Rifampin is contraindicated when used with itraconazole)
- •10. Current treatment with an antifungal drug for confirmed or suspected penicilliosis for >48 hours
- •Original exclusion criteria (until 15/02/2012):
- •1. Age < 15
- •2. Pregnancy or urine ß-hCG positive
- •3. History of allergy or severe reaction to either itraconazole or amphotericin B
- •4. Unable to take oral medications
- •5. Documented treatment failure due to suspected drug resistance to either itraconazole or amphotericin B from another hospital or an outpatient clinic
- •6. Use of the following prohibited drugs: phenytoin, barbiturates, carbamazepine, rifampin, isoniazid, H2 blocker, HMG-CoA reductase inhibitors, cisapride, terfenadine, midazolam, dihydropyridine calcium channel blocker, cyclosporine, cyclophosphamide, tacrolimus, digoxin, coumadin, or investigational drugs.
- •7. Baseline aspartate transaminase (AST) or al
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