CompletedPhase 4

Extended Duration Artemether-lumefantrine Treatment for Malaria in Children

Uganda305 participantsStarted 2018-02-21

Plain-language 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.

Who can participate

Age range

6 Months – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Residency within 60 km of the study clinics either at TDH or at MGH
. Agreement to come to clinic for all follow-up clinical and PK evaluations
. Provision of informed consent
. Weight ≥6 kg
. Presentation with uncomplicated falciparum malaria as indicated by positive smear for malaria parasites along with clinical evidence of infection (fever or history of fever in the past 24 hours)
. Willingness to undergo intensive PK sampling and/or population PK sampling during episode(s) of malaria.
. Confirmed HIV infection (positive rapid HIV test to be confirmed by Western Blot or HIV RNA after enrollment)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

AUC0-21d

Timeframe: Study day 0-day21

Recurrent Parasitemia Following Treatment by Day 42 (Recrudescence or New Infection)

Timeframe: up to study day 42

AUC0-8h for Artemether

Timeframe: 0-8hr

AUC0-8h for Dihydroartemisinin

Timeframe: 0-8hr

Cmax for Lumefantrine

Timeframe: 0-21 days

Cmax for Artemether

Timeframe: 0-8hr

Cmax for Dihydroartemisinin

Timeframe: 0-8hr

Trial details

NCT IDNCT03453840

SponsorUniversity of California, San Francisco

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-08-31

Results submitted2024-05-30

View on ClinicalTrials.gov More Uncomplicated Plasmodium Falciparum Malaria trials

Plain-language summary

Who can participate

Age range

6 Months – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Residency within 60 km of the study clinics either at TDH or at MGH
. Agreement to come to clinic for all follow-up clinical and PK evaluations
. Provision of informed consent
. Weight ≥6 kg
. Presentation with uncomplicated falciparum malaria as indicated by positive smear for malaria parasites along with clinical evidence of infection (fever or history of fever in the past 24 hours)
. Willingness to undergo intensive PK sampling and/or population PK sampling during episode(s) of malaria.
. Confirmed HIV infection (positive rapid HIV test to be confirmed by Western Blot or HIV RNA after enrollment)

What they're measuring

AUC0-21d

Timeframe: Study day 0-day21

Recurrent Parasitemia Following Treatment by Day 42 (Recrudescence or New Infection)

Timeframe: up to study day 42

AUC0-8h for Artemether

Timeframe: 0-8hr

AUC0-8h for Dihydroartemisinin

Timeframe: 0-8hr

Cmax for Lumefantrine

Timeframe: 0-21 days

Cmax for Artemether

Timeframe: 0-8hr

Cmax for Dihydroartemisinin

Timeframe: 0-8hr

Extended Duration Artemether-lumefantrine Treatment for Malaria in Children

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Extended Duration Artemether-lumefantrine Treatment for Malaria in Children

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria