P1079 / PHARMACOLOGY OF ARTEMISININ-BASED ANTIMALARIAL THERAPY

P1079 is a prospective, pharmacokinetic (PK) study to investigate the drug-drug interaction between the antimalarial treatment artemether/lumefantrine (AL) and nevirapine (NVP)-based antiretroviral (ARV) treatment for HIV, in co-infected children in resource limited settings.  The primary objectives of the study are to determine if NVP-based ARV therapy versus no ARV therapy alters the AL PK exposure in children (ages ≥3 to ≤12 years) who are co-infected with malaria and HIV and to evaluate the 28 and 42-day safety and toxicity following co-administration of 6 doses of AL with NVP.  (Arm A only).  The target enrollment is 48 evaluable participants (24 on a NVP-based ARV regimen; 24 on no ARV regimen); each subject would receive 6 doses of AL over a 4 day period and would be followed for 42 days from entry.