PACTR2010030001971409已完成未知
Special populations and label explansion studies with the fixed does combinations artemether-lumefantrine, amodiaquine-artesunate, and dihydroartemisinin-piperaquine in Zambia, Malawi and Mozambique
iverpool School of Tropical Medicine0 个研究点目标入组 155 人开始时间: 2010年3月8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
- 155
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Year(s) 至 60 Year(s)（—）
- 性别
- All
入选标准
- •1.Residence of Blantyre City and the neighbouring districts.
- •2.Confirmed HIV positive clients
- •a.ART naïve: with CD4 Cell count ¿350 cells/mm3
- •b.ART-treated: with CD4 cell count ¿250 cells/mm3 and receiving first-line, alternative first line or second line ART, as described in the background section, for ¿6 months.
- •3.Age ¿18 years
- •4.Ability to read and write and provide informed consent
- •5.Body weight at least 40kgs (so that they are eligible to receive recommended adult doses of the antimalarial drug)
- •6.Stated willingness to be contacted by phone or at home.
- •7.Stated willingness to be admitted in the hospital for 3 days and to remain within the vicinity of Blantyre city for 2 months after enrolment.
排除标准
- •1.Body Mass Index less than 18.5kg/m2
- •2.CD4 Cell count <350 cells/mm3 among antiretroviral naïve subjects and CD4 Cell count <250 cells/mm3 among ART-treated subjects.
- •3.Hemoglobin <8.5 g/dL
- •4.Receiving any antimalarial drugs within the past 4 weeks.
- •5.Receiving other drugs which are known inhibitors or inducers of P450 enzymes of P-glycoprotein (except cotrimoxazole prophylaxis, which is the standard of care in HIV-infected people).
- •6.History of regular intake of alcohol (>twice/week), tobacco (>3 times/week) or any use of illicit drugs
- •7.History or evidence of pre-existing diseases of the liver and kidneys ie if the serum transaminases levels are >3 times the upper limit of normal or urea and creatinine levels >1.5 times the upper limit of normal.
- •8.History or evidence of heart disease, including conductive abnormalities on electrocardiographs (ECGs) ie QTc interval>450ms (men) and >470ms (females)
- •9.Clinical and/or laboratory evidence of other infections in addition to HIV, such as clinical malaria or microscopic asexual forms of Pf malaria, hepatitis B, pneumonia, tuberculosis, bacteremia etc.
- •10.Laboratory evidence of potentially life threatening white blood cell disorders such as neutropenia (absolute neutrophil count < 0.500*109), lymphopenia (absolute lymphocyte count <0.35*109) and thrombocytopenia (absolute platelet count <25*109).
- •11.Physically unfit with Karnofsky score of <80%.
- •12.Hypersensitivity to any of the ACTs.
- •13.Pregnancy ie confirmed by a Human Chorionic Gonadotrophin test.
- •14.Current participation in any other therapeutic or vaccine trial
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