CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 305 enrolled
Drug / intervention
Artemether-lumefantrinedrug
Likely dose
Artemether-lumefantrine 20 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03453840
NCT03453840Phase 4Completed
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Extended Duration Artemether-lumefantrine Treatment for Malaria in Children

University of California, San Francisco·interventional·Posted Mar 5, 2018·Updated Apr 15, 2025

In Brief

A Phase 4 clinical trial evaluating Artemether-lumefantrine for Uncomplicated Plasmodium Falciparum Malaria. Completed, enrolled 305 participants across 2 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUncomplicated Plasmodium Falciparum Malaria
CountriesUganda
CollaboratorsEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Yale University, Infectious Diseases Research Collaboration, Uganda

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedMar 5, 2018
Enrollment StartFeb 21, 2018
Primary CompletionAug 31, 2021
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 8.3 years ago

Interventions

Artemether-lumefantrinedrug

Children will receive the dispersible formulation of AL which contains 20 mg artemether, 120 mg of lumefantrine (Coartem® Dispersible). Weight-based dosing will be as below: \<15kg, 1tablet; 15-25kg, 2 tablets; 25-35kg, 3 tablets; \>=35kg, 4 tablets.