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Extended Duration Artemether-lumefantrine Treatment for Malaria in Children

NCT03453840 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 305

Last updated 2025-04-15

Study results available
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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.

Conditions

  • Uncomplicated Plasmodium Falciparum Malaria

Interventions

DRUG

Artemether-lumefantrine

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.

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Yale University

    collaborator OTHER

  • Infectious Diseases Research Collaboration, Uganda

    collaborator OTHER

  • University of California, San Francisco

    lead OTHER

Principal Investigators

  • Francesca Aweeka, Pharm. D · University of California, San Francisco

  • Sunil Parikh, M.D., MPH · Yale University School of Public Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-21
Primary Completion
2021-08-31
Completion
2021-08-31

Countries

  • Uganda

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03453840 on ClinicalTrials.gov