Extended Duration Artemether-lumefantrine Treatment for Malaria in Children (NCT03453840) | Clinical Trial Compass
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 range6 Months – 18 Years
SexALL
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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)
✓. On stable EFV-based ART for at least 10 days prior to enrollment
Exclusion criteria
✕. History of significant comorbidities such as malignancy, active tuberculosis or other World Health Organization (WHO) stage 4 disease
What they're measuring
1
AUC0-21d
Timeframe: Study day 0-day21
2
Recurrent Parasitemia Following Treatment by Day 42 (Recrudescence or New Infection)
✕. Current infection with non-P. falciparum species
✕. Receipt of any medications known to affect CYP450 metabolism (except ART) within 14 days of study enrollment (see 4.2.2)
✕. Hemoglobin \< 7.0 g/dL
✕. For the population PK study, prior treatment for malaria within 14 days of enrollment
✕. For the intensive PK study, prior treatment for malaria within 28 days of enrollment
✕. Signs or evidence of complicated malaria, defined as unarousable coma or any two of the following symptoms: Recent febrile convulsions, altered consciousness, lethargy, unable to drink, unable to stand/sit due to weakness, severe anemia (Hb \< 5.0 gm/dL), respiratory distress, jaundice (see Appendix D)