Extended Duration Artemether-lumefantrine Treatment for Malaria in Children
Status:
Completed
Trial end date:
2020-01-09
Target enrollment:
Participant gender:
Summary
This project will determine 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 will be enrolled for intensive PK studies, as well as additional
children for population PK studies to enhance association analyses with clinical outcomes.
Phase:
Phase 4
Details
Lead Sponsor:
University of California, San Francisco
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Infectious Diseases Research Collaboration, Uganda Yale University
Treatments:
Artemether Artemether-lumefantrine combination Artemether, Lumefantrine Drug Combination Artemisinins Lumefantrine