Registered outcomes15

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

1 to 15 of 15

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.
Other	Height-for-age (HFA) Associations With PK	study day 0	chronic protein-calorie malnutrition resulting in slow linear growth (decreased height-for-age: HFA; stunting).
Other	Diagnostic Sensitivity of LAMP, HS-RDT, and Microscopy for the Detection of Recurrent Parasitemia	study day 0-42	Using Loop-mediated isothermal amplification (LAMP), highly sensitive Rapid Diagnostic Test (HS-RDT), and microscope to diagnose recurrent parasitemia. study day 0-42
Other	Weight-for-height (WFH) Associations With PK	study day 0	acute protein-calorie malnutrition resulting in weight loss or slow weight gain (decreased weight-for-height: WFH; wasting).
Other	Weight-for-age (WFA) Associations With PK	study day 0	weight-for-age is an indicator of nutrition status and decreased weight-for-age reflects the combination of chronic and acute protein-calorie malnutrition.
Other	Prevalence of Gametocytemia	study day 0-42	At varied time points, blood smears for the determination of parasitemia will be obtained following treatment in 3-day vs 5-day AL regimens.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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.

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