Extended Duration Artemether-lumefantrine Treatment for Malaria in Children (EXALT)

NCT03453840 PHASE4 COMPLETED Results posted

This project determines the pharmacokinetic/pharmacodynamic (PK/PD) of an extended artemether-lumefantrine (AL) dosing regimen in HIV-infected children on efavirenz (EFV)-based antiretroviral therapy (ART) that is designed to improve the PK exposure and treatment efficacy of this artemisinins-based combination therapy (ACT) regimen. Our overarching goal is to inform the best treatment guidelines for young children in Africa. HIV-infected and HIV-uninfected children were enrolled for intensive PK studies, as well as additional children for population PK studies to enhance association analyses with clinical outcomes.

Details

Lead sponsor	University of California, San Francisco
Phase	PHASE4
Status	COMPLETED
Enrolment	305
Start date	Wed Feb 21 2018 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Tue Aug 31 2021 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Uncomplicated Plasmodium Falciparum Malaria

Interventions

• Artemether-lumefantrine

Countries

Uganda