Special populations and label expansion studies with the fixed dose 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 66 人开始时间: 2010年1月26日最近更新: 2023年5月29日

适应症

试验速览

暂无简介。

•1.Blantyre City residents
•2.Confirmed HIV positive clients
•a.Controls group (ART naïve): with CD4 Cell count more than 250 cells/mm3
•b.Intervention group (ART-treated): with CD4 cell count more than 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 in Blantyre city for 2 months after enrolment.

•1.Body Mass Index less than 18.5kg/m2
•2.CD4 Cell count <250 cells/mm3
•3.Hemoglobin <10 g/dL
•4.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).
•5.History of regular intake of alcohol (>twice/week), tobacco (>3 times/week) or any use of illicit drugs
•6.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.
•7.History or evidence of heart disease, including conductive abnormalities on electrocardiographs (ECGs) ie QTc interval>450ms (men) and >470ms (females)
•8.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.
•9.Laboratory evidence of white blood cell disorders such as neutropenia, lymphopenia and thrombocytopenia.
•10.Physically unfit with Karnofsky score of <80%.
•11.Hypersensitivity to any of the ACTs.
•12.Pregnancy ie confirmed by a Human Chorionic Gonadotrophin test.
•13.Current participation in any other therapeutic or vaccine trial

发起方

iverpool School of Tropical Medicine