EXALT PK TRIAL: Extended duration Artemether-Lumefantrine treatment for malaria in children
Study period:Ongoing.
The study is currently being conducted at Masafu General Hospital (MGH) in Busia, and its referral centers. It is a randomized open-label prospective pharmacokinetic and pharmacodynamic study of extended duration artemether-lumefantrine in HIV-infected children on EFV-based ART and HIV-uninfected children. Children are randomly assigned to 3-day or 5-day regimens for their first intensive and population study. Thereafter one is eligible for a sequential crossover (3-day followed by 5-day AL or vice versa for two episodes of malaria).
Objectives:
- To evaluate and compare the PK exposure between 5-day AL treatment and 3-day al treatment in HIV-infected children on EFV-based ART.
- To evaluate and compare the PK exposure of 3-day and 5-day AL treatment in HIV-infected children on EFV-based ART to 3-day AL treatment in HIV-uninfected children not on ART.
- To evaluate and compare the PK exposure of 3-day and 5-day AL treatment in HIV-uninfected children not on ART.
- To evaluate the pharmacodynamics of AL in the context of extended dose regimens and HIV infection.
