Status:
COMPLETED
Extended Duration Artemether-lumefantrine Treatment for Malaria in Children
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Yale University
Conditions:
Uncomplicated Plasmodium Falciparum Malaria
Eligibility:
All Genders
6-18 years
Phase:
PHASE4
Brief 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 ...
Detailed Description
This is a prospective multi-site study to evaluate the PK/PD of extended duration AL in HIV-infected children on EFV-based ART and HIV-uninfected children not on ART. AL is the first-line treatment fo...
Eligibility Criteria
Inclusion
- 1, All participants:
- 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.
- 2 HIV-infected participants:
- 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
- Age 3 years to 18 years
- 3 HIV-uninfected participants:
- Confirmed HIV negative test (negative rapid HIV test to be confirmed by Western Blot or HIV RNA after enrollment)
- Age 6 months to 18 years
Exclusion
- History of significant comorbidities such as malignancy, active tuberculosis or other World Health Organization (WHO) stage 4 disease
- 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)
- History of toxicity to AL
- The following medications are disallowed within 3 weeks prior to receiving study drug:
- Carbamazepine
- Clarithromycin
- Erythromycin (oral)
- Ketoconazole
- Phenobarbital
- Phenytoin
- Rifabutin
- Rifampin
- Halofantrine
- Any other medication known to significantly affect CYP450 metabolism.
- Grapefruit juice should be avoided during the study due to its potential effects on CYP3A4.
Key Trial Info
Start Date :
February 21 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2021
Estimated Enrollment :
305 Patients enrolled
Trial Details
Trial ID
NCT03453840
Start Date
February 21 2018
End Date
August 31 2021
Last Update
April 15 2025
Active Locations (2)
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1
MGH campus
Busia, Uganda
2
IDRC- Tororo Research Clinic and Tororo District Hospital
Tororo, Uganda