Project 03

EFFICACY

Efficacy, safety and pharmacokinetic exposure of artemether lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in HIV uninfected and HIV infected children on antiretroviral treatment in Lilongwe, Malawi.

Project Duration: 3 Years (November 2020 – October 2023)

Principal Investigator: Dr Nyanyiwe Masingi Mbeye

Efficacy is a two-arm prospective observational study of malaria clinical and parasitological responses to artemether lumefantrine (AL), the first line treatment for uncomplicated malaria in Malawi, in HIV infected children receiving standard antiretroviral drugs as well as HIV uninfected children aged between 6 months and 16 years. Children with confirmed uncomplicated malaria infection, who meet the study inclusion criteria, are enrolled, treated on site with AL and monitored for 28 days. The follow-up consists of a fixed schedule of check-up visits and corresponding clinical and laboratory examinations. On the basis of the results of these assessments, the participants will be classified as having therapeutic failure (early or late) or an adequate clinical and parasitological response.

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 recrudescent infection, usually due to treatment failure, and reinfection. On day 7, post treatment initiation, a blood sample is 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.

Funding

EDCTP
Research Council of Norway

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