Public Health - International Health
Antimalarial treatment efficacy of artemether-lumefantrine in HIV-infected pregnant women.
Artemether-lumefantrine is the leading drug recommended by the World Health Organization (WHO) for the treatment of uncomplicated malaria. High treatment efficacy, good tolerability, and an acceptable safety profile of artemether-lumefantrine have been established in non-pregnant adults and children. However, despite increasing use of the drug in pregnant women in many endemic countries following the WHO recommendation, knowledge on the safety and efficacy of artemether-lumefantrine is extremely limited in pregnant women, especially in those living with HIV, who carry the highest burden of malaria-HIV co-infection. Available data suggest that pregnancy- and HIV-related immune suppression and suboptimal pharmacokinetics secondary to pregnancy-induced acceleration in drug disposition may hamper the efficacy and safety of artemether-lumefantrine. In collaboration with our colleagues in Mali, we propose to conduct a prospective clinical study to assess the efficacy and safety of artemether-lumefantrine in HIV-infected pregnant women. Thirty-five women with microscopy-proven uncomplicated falciparum malaria will be treated with the standard 6-doses of artemether-lumefantrine. Parasitemia will be monitored daily for 3 days and weekly for 6 weeks. The primary endpoint is the adequate clinical and parasitologic response determined at 42 days after the initiation of treatment. Safety monitoring will include both clinical and laboratory evaluation. The study findings will serve as preliminary data for a larger clinical trial to evaluate the relative contribution of acquired immunity, drug pharmacokinetics and drug resistance in antimalarial treatment outcomes of artemether-lumefantrine in HIV-infected pregnant women for which a clinical trial planning grant (R34) has been recently submitted to NIAID.
Craig W. Hendrix, M.D.; JH School of Medicine, Medicine, Div. of Clinical Pharmacology