Trial · NCT03453840

Extended Duration Artemether-lumefantrine Treatment for Malaria in Children

NCT03453840, Phase 4, Completed, University of California, San Francisco; results first posted 2025-01-03

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Extended Duration Artemether-lumefantrine Treatment for Malaria in Children. Trials, record NCT03453840. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03453840

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Extended Duration Artemether-lumefantrine Treatment for Malaria in Children
NCT number: NCT03453840
Status: Completed
Phases: Phase 4
Enrollment: 305 participants, actual
Lead sponsor: University of California, San Francisco
Conditions: Uncomplicated Plasmodium Falciparum Malaria
Interventions: Artemether-lumefantrine
First posted: 2018-03-05
Last updated: 2025-04-15
Results first posted: 2025-01-03

Source ClinicalTrials.gov

Registered outcomes15

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	AUC0-21d	Study day 0-day21	Area under the plasma concentration versus time curve (AUC) from time 0 to day 21 for lumefantrine
Primary	Recurrent Parasitemia Following Treatment by Day 42 (Recrudescence or New Infection)	up to study day 42	Recurrent malaria determined by microscopy (thick blood smears), loop mediated isothermal amplification (LAMP), or rapid diagnostic test (RDT).
Primary	AUC0-8h for Artemether	0-8hr	Area under the plasma concentration versus time curve (AUC) from 0 to 8hr post last dose for artemether (ARM)
Primary	AUC0-8h for Dihydroartemisinin	0-8hr	Area under the plasma concentration versus time curve (AUC) from time 0 to 8hr post last dose for Dihydroartemisinin (DHA)
Primary	Cmax for Lumefantrine	0-21 days	Maximal concentration post last dose for lumefantrine
Primary	Cmax for Artemether	0-8hr	Maximal concentration post last dose for artemether
Primary	Cmax for Dihydroartemisinin	0-8hr	Maximal concentration post last dose for dihydroartimisinin (DHA)
Secondary	Number of Participants With Serious Adverse Events	study day 0-42	We recorded participants tolerance of AL using the NIH Division of AIDS Adult and Pediatric Toxicity Tables.
Other	Relationship Between Drug Resistance and Treatment Failure	study day 0-42	drug resistance will be accessed by molecular markers. Polymorphic markers will be typed using capillary electrophoresis.
Other	Metabolomic Measurements in HIV Infected vs HIV Uninfected Children	study day 0-42	Small-molecule metabolites, including metabolic intermediates, hormones and other signaling molecules, and secondary metabolites will be measured in plasma and reported as fold-change (e.g. infected vs uninfected). This is an exploratory study. The multiple measurements could be aggregated to fold-change.

1 to 10 of 15Source ClinicalTrials.gov

See all 15 registered outcomes

Outcomes15

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	AUC0-21d	Study day 0-day21	Intensive PK participants only. Population PK participants are excluded here.	hr*ug/mL	GEOMETRIC_MEAN
PRIMARY	Recurrent Parasitemia Following Treatment by Day 42 (Recrudescence or New Infection)	up to study day 42	All participants including intensive and population PK participants.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	AUC0-8h for Artemether	0-8hr	Intensive PK participants only, so the participant number here is different from the numbers in the participant flow module, which includes both intensive and population PK participants.	hr*ng/mL	GEOMETRIC_MEAN
PRIMARY	AUC0-8h for Dihydroartemisinin	0-8hr	Intensive PK participants only, so the participant number here is different from the numbers in the participant flow module, which includes both intensive and population PK participants.	hr.ng/mL	GEOMETRIC_MEAN
PRIMARY	Cmax for Lumefantrine	0-21 days		ng/mL	GEOMETRIC_MEAN
PRIMARY	Cmax for Artemether	0-8hr		ng/mL	GEOMETRIC_MEAN
PRIMARY	Cmax for Dihydroartemisinin	0-8hr		ng/mL	GEOMETRIC_MEAN
SECONDARY	Number of Participants With Serious Adverse Events	study day 0-42		Participants	COUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIED	Relationship Between Drug Resistance and Treatment Failure	study day 0-42
OTHER_PRE_SPECIFIED	Metabolomic Measurements in HIV Infected vs HIV Uninfected Children	study day 0-42

1 to 10 of 15Source ClinicalTrials.gov

See all 15 outcomes

Results by group32

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
AUC0-21d	HIV-infected 3-day AL Intensive PK	144	95% Confidence Interval 114 to 182	hr*ug/mL
AUC0-21d	HIV-infected 5-day AL Intensive PK	205	95% Confidence Interval 151 to 279	hr*ug/mL
AUC0-21d	HIV-uninfected 3-day AL Intensive PK	259	95% Confidence Interval 222 to 302	hr*ug/mL
AUC0-21d	HIV-uninfected 5-day AL Intensive PK	318	95% Confidence Interval 274 to 370	hr*ug/mL
Recurrent Parasitemia Following Treatment by Day 42 (Recrudescence or New Infection)	HIV-infected 3-day AL	19		Participants
Recurrent Parasitemia Following Treatment by Day 42 (Recrudescence or New Infection)	HIV-infected 5-day AL	18		Participants
Recurrent Parasitemia Following Treatment by Day 42 (Recrudescence or New Infection)	HIV-uninfected 3-day AL	80		Participants
Recurrent Parasitemia Following Treatment by Day 42 (Recrudescence or New Infection)	HIV-uninfected 5-day AL	66		Participants
AUC0-8h for Artemether	HIV-infected 3-day AL Intensive PK	64.0	95% Confidence Interval 45.5 to 90	hr*ng/mL
AUC0-8h for Artemether	HIV-infected 5-day AL Intensive PK	71.7	95% Confidence Interval 54.8 to 93.8	hr*ng/mL

1 to 10 of 32Source ClinicalTrials.gov

See all 32 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	HIV-infected 3-day AL	39
Overall Study	STARTED	HIV-infected 5-day AL	37
Overall Study	STARTED	HIV-uninfected 3-day AL	115
Overall Study	STARTED	HIV-uninfected 5-day AL	114
Overall Study	COMPLETED	HIV-infected 3-day AL	35
Overall Study	COMPLETED	HIV-infected 5-day AL	36
Overall Study	COMPLETED	HIV-uninfected 3-day AL	110
Overall Study	COMPLETED	HIV-uninfected 5-day AL	110
Overall Study	NOT COMPLETED	HIV-infected 3-day AL	4
Overall Study	NOT COMPLETED	HIV-infected 5-day AL	1

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events8

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
serious	hypoglycemia	Blood and lymphatic system disorders	HIV-infected 3-day AL		35
serious	hypoglycemia	Blood and lymphatic system disorders	HIV-infected 5-day AL		36
serious	hypoglycemia	Blood and lymphatic system disorders	HIV-uninfected 3-day AL	1	114	1
serious	hypoglycemia	Blood and lymphatic system disorders	HIV-uninfected 5-day AL		113
serious	anemia	Blood and lymphatic system disorders	HIV-infected 3-day AL		35
serious	anemia	Blood and lymphatic system disorders	HIV-infected 5-day AL		36
serious	anemia	Blood and lymphatic system disorders	HIV-uninfected 3-day AL	1	114	1
serious	anemia	Blood and lymphatic system disorders	HIV-uninfected 5-day AL		113

Source ClinicalTrials.gov

Adverse event totals12

The totals the trial posted for each group.

Total	Group	At risk
Total, all-cause mortality	HIV-infected 3-day AL	35
Total, all-cause mortality	HIV-infected 5-day AL	36
Total, all-cause mortality	HIV-uninfected 3-day AL	114
Total, all-cause mortality	HIV-uninfected 5-day AL	113
Total, other adverse events	HIV-infected 3-day AL	35
Total, other adverse events	HIV-infected 5-day AL	36
Total, other adverse events	HIV-uninfected 3-day AL	114
Total, other adverse events	HIV-uninfected 5-day AL	113
Total, serious adverse events	HIV-infected 3-day AL	35
Total, serious adverse events	HIV-infected 5-day AL	36

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
36130191	RESULT	PubMed
38714692	DERIVED	PubMed
39853752	RESULT	PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01HD068174	Optimizing HIV-malaria treatment in a shifting treatment and resistance landscape in Africa	PARIKH, SUNIL; AWEEKA, FRANCESCA T.	YALE UNIVERSITY	EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT	2011 to 2025

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

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