Malaria

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Browsing Malaria by Author "Mbeye, Nyanyiwe"

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    Efficacy, safety and pharmacokinetic exposure of artemether lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in HIV infected Malawian children on antiretroviral treatment
    (Kamuzu University of Health Sciences, 2021-03-17) Mbeye, Nyanyiwe
    Type of research study: A prospective observational study will recruit and follow up two groups of children aged between 6 months and 16 years diagnosed with uncomplicated malaria in Lilongwe district. One group will be HIV infected and on antiretroviral treatment and another one will be HIV uninfected. The problem: There is paucity of consolidated evidence to guide optimisation of the current arsenal of drugs that are used to fight malaria in individuals co-infected with HIV especially in key at-risk subpopulations such as children. Potential drug-drug interactions between antimalarial drugs and antiretroviral therapy (ART) raise concern in the control of malaria in children who are co-infected with HIV. Artemether-lumefantrine (AL) is a commonly used artemisinin-based combination therapy (ACT) in most malaria programmatic settings but there is limited understanding of its efficacy in malaria and HIV co-infected children in light of the potential drug-drug interactions between ACTs and ART. WHO recommends countries to evaluate efficacy of their first-line antimalarial drugs at least once every two years. Since these studies are done in HIV negative children, there is an important need to assess the efficacy of first-line antimalarial drugs in HIV infected children on ART as well. Objective: This study aims to evaluate the efficacy and safety of artemether lumefantrine (AL) for the treatment of uncomplicated P. falciparum malaria in HIV infected and HIV uninfected children in Lilongwe, Malawi. Methodology: A prospective observational study of antimalarial efficacy will be conducted in a total of 71 HIV-malaria coinfected children on ART and 141 HIV uninfected children with confirmed malaria who meet the inclusion criteria. Once enrolled, participants will be given AL for treatment and followed up for 28 days. The follow up will consist of fixed schedule of visits (at Day 1,2,3,7,14,21 and 28) with corresponding clinical and laboratory examinations. The proportion of participants experiencing therapeutic failure during the follow-up period will be used to estimate the efficacy of AL. PCR analysis will be used to distinguish between recrudescence and reinfection. On day 7, post treatment initiation, a blood sample will be collected to quantify lumefantrine concentrations, as a predictor of overall lumefantrine exposure. These concentrations will be correlated with AL treatment efficacy. The design has adapted some procedures of the recommended WHO methods for surveillance of antimalarial drug efficacy. Expected findings and their dissemination: This study is designed to generate the information required to assess whether AL is efficacious in HIV infected children on ART. It is anticipated that the study results will improve the management of malaria in HIV infected children on antiretroviral drugs in areas affected by both HIV and malaria. This study will also provide information on the pharmacokinetics of AL and its efficacy that would contribute to the development of appropriate approaches/options for optimal effectiveness of the treatment. The findings of this study will be published in peer-reviewed journals and shared with all relevant stakeholders.