Uncomplicated Plasmodium Falciparum MalariaPhase 4EXALTNCT03453840
Extended Duration Artemether-lumefantrine Treatment for Malaria in Children
A Phase 4 study testing Artemether-lumefantrine in people with Uncomplicated Plasmodium Falciparum Malaria, run by University of California, San Francisco at 2 sites in Uganda.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- Uncomplicated Plasmodium Falciparum Malaria
- What is being tested?
- Artemether-lumefantrine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 305 participants
- Where
- 2 sitesUganda
- Study dates
- 21 Feb 2018to 31 Aug 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Show all 14Show fewer
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
Uganda2 sites
MGH campus
Busia
IDRC- Tororo Research Clinic and Tororo District Hospital
Tororo
About this study
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.
Read the 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 for malaria in Uganda. No change in standard of care treatment was made for the purposes of this study except for the extension of AL to 5-day dosing. This study enrolled a) HIV-infected children, and b) HIV-uninfected children. All participants may be enrolled through Tororo District Hospital (TDH) or Masafu General Hospital (MGH) in Busia, or other referral centers the area. we used a design where children were randomized to either 3-day or 5-day AL and then for subsequent episodes of malaria, should they occur. Conservatively, assuming each enrolled child participates for only a single episode of malaria, up to 60 (30 HIV-infected on 3-day and 30 HIV-infected on 5-day) and 100 (50 HIV-uninfected on 3-day and 50 HIV-uninfected on 5-day) subjects were enrolled for each of the intensive study groups. 16 (9 HIV-infected on 3-day and 7 HIV-infected on 5-day) and 120 (60 HIV-uninfected on 3-day and 60 HIV-uninfected on 5-day) subjects were enrolled for each of the population study groups. Enrollment of HIV-infected subjects for population PK study groups was not halted due to the lack of HIV-infected children in the study area. Comparisons of AL PK exposure were made among and between a) HIV-infected children with malaria receiving EFV-based ART and b) HIV-uninfected children who are not on ART. Comparisons were based on an intensive PK design for AL area under the concentration-time curve (AUC) estimations.
- Being tested
- Artemether-lumefantrine
- Keywords
- malaria, HIV, Children, Efavirenz, artemether, lumefantrine
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artemether-lumefantrineDrug
Also called Coartem, AL
Children will receive the dispersible formulation of AL which contains 20 mg artemether, 120 mg of lumefantrine (Coartem® Dispersible). Weight-based dosing will be as below: <15kg, 1tablet; 15-25kg, 2 tablets; 25-35kg, 3 tablets; >=35kg, 4 tablets.
| Study group | Role | What they receive |
|---|---|---|
| HIV-infected 3-day AL | Active comparator | Standard 3-day twice daily (BID) regimen of artemether-lumefantrine for uncomplicated malaria, given over 4 days (Study Days 0, 1, 2 and 3) so that sampling will begin in the morning of day 3. These participants are HIV-infected and stabilized on EFV-based ART. Receives: Drug: Artemether-lumefantrine |
| HIV-infected 5-day AL | Experimental | Extended 5-day BID regimen of artemether-lumefantrine, given over 6 days (Study Days 0, 1, 2, 3, 4, and 5) so that sampling will begin in the morning of day 5. These participants are HIV-infected and stabilized on EFV-based ART. Receives: Drug: Artemether-lumefantrine |
| HIV-uninfected 3-day AL | Active comparator | Standard 3-day BID regimen of artemether-lumefantrine for uncomplicated malaria, given over 4 days (Study Days 0, 1, 2 and 3) so that sampling will begin in the morning of day 3. These participants are HIV-uninfected. Receives: Drug: Artemether-lumefantrine |
| HIV-uninfected 5-day AL | Experimental | Extended 5-day BID regimen of artemether-lumefantrine, given over 6 days (Study Days 0, 1, 2, 3, 4, and 5) so that sampling will begin in the morning of day 5. These participants are HIV-uninfected. Receives: Drug: Artemether-lumefantrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-21d
Area under the plasma concentration versus time curve (AUC) from time 0 to day 21 for lumefantrine
Measured: Study day 0-day21
Recurrent Parasitemia Following Treatment by Day 42 (Recrudescence or New Infection)
Recurrent malaria determined by microscopy (thick blood smears), loop mediated isothermal amplification (LAMP), or rapid diagnostic test (RDT).
Measured: up to study day 42
AUC0-8h for Artemether
Area under the plasma concentration versus time curve (AUC) from 0 to 8hr post last dose for artemether (ARM)
Measured: 0-8hr
AUC0-8h for Dihydroartemisinin
Area under the plasma concentration versus time curve (AUC) from time 0 to 8hr post last dose for Dihydroartemisinin (DHA)
Measured: 0-8hr
Cmax for Lumefantrine
Maximal concentration post last dose for lumefantrine
Measured: 0-21 days
Cmax for Artemether
Maximal concentration post last dose for artemether
Measured: 0-8hr
Cmax for Dihydroartemisinin
Maximal concentration post last dose for dihydroartimisinin (DHA)
Measured: 0-8hr
Secondary outcomes (1)
Number of Participants With Serious Adverse Events
We recorded participants tolerance of AL using the NIH Division of AIDS Adult and Pediatric Toxicity Tables.
Measured: study day 0-42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2018
- Study start21 Feb 2018
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Uncomplicated Plasmodium Falciparum MalariaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective multi-site study accomplished through a randomized design where children will be randomized to either 3-day or 5-day AL regimen and then for subsequent episodes of malaria, should they occur..
- Masking
- None (open label)
- Enrolment
- 305 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Yale University, Infectious Diseases Research Collaboration, Uganda
- Responsible party
- Sponsor
- Investigators
- Francesca Aweeka, Pharm. D, Principal investigator, University of California, San FranciscoSunil Parikh, M.D., MPH, Principal investigator, Yale University School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03453840
- Sponsor's protocol ID
- 17-22578
- Other IDs
- 2R01HD068174-06A1
- Acronym
- EXALT
- Status last verified
- Apr 2025
- First submitted
- 22 Dec 2017
- Last updated
- 15 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Whalen ME, Kajubi R, Goodwin J, Orukan F, Colt M, Huang L, Richards K, Wang K, Li F, Mwebaza N, Aweeka FT, Parikh S. The Impact of Extended Treatment With Artemether-lumefantrine on Antimalarial Exposure and Reinfection Risks in Ugandan Children With Uncomplicated Malaria: A Randomized Controlled Trial. Clin Infect Dis. 2023 Feb 8;76(3):443-452. doi: 10.1093/cid/ciac783.
PubMed 36130191Whalen ME, Kajubi R, Goodwin J, Orukan F, Colt M, Huang L, Richards K, Hoffmann TJ, Aweeka FT, Parikh S, Mwebaza N. Extended Treatment Duration of Artemether-Lumefantrine in Ugandan Children with HIV on Efavirenz-Based Antiretroviral Therapy: A Randomized Controlled Pharmacokinetic and Pharmacodynamic Trial. J Clin Pharmacol. 2025 Jul;65(7):909-922. doi: 10.1002/jcph.6193. Epub 2025 Jan 24.
PubMed 39853752Goodwin J, Kajubi R, Wang K, Li F, Wade M, Orukan F, Huang L, Whalen M, Aweeka FT, Mwebaza N, Parikh S. Persistent and multiclonal malaria parasite dynamics despite extended artemether-lumefantrine treatment in children. Nat Commun. 2024 May 7;15(1):3817. doi: 10.1038/s41467-024-48210-7.
PubMed 38714692
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended Duration Artemether-lumefantrine Treatment for Malaria in Children
- ClinicalTrials.gov ID
- NCT03453840
- Acronym / sponsor ID
- EXALT / 17-22578
- Keywords
- malaria, HIV, Children, Efavirenz, artemether, lumefantrine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 305 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Yale University, Infectious Diseases Research Collaboration, Uganda
- Study start
- 21 Feb 2018 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 5 Mar 2018 (actual)
- Results
- Posted 3 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 for malaria in Uganda. No change in standard of care treatment was made for the purposes of this study except for the extension of AL to 5-day dosing. This study enrolled a) HIV-infected children, and b) HIV-uninfected children. All participants may be enrolled through Tororo District Hospital (TDH) or Masafu General Hospital (MGH) in Busia, or other referral centers the area. we used a design where children were randomized to either 3-day or 5-day AL and then for subsequent episodes of malaria, should they occur. Conservatively, assuming each enrolled child participates for only a single episode of malaria, up to 60 (30 HIV-infected on 3-day and 30 HIV-infected on 5-day) and 100 (50 HIV-uninfected on 3-day and 50 HIV-uninfected on 5-day) subjects were enrolled for each of the intensive study groups. 16 (9 HIV-infected on 3-day and 7 HIV-infected on 5-day) and 120 (60 HIV-uninfected on 3-day and 60 HIV-uninfected on 5-day) subjects were enrolled for each of the population study groups. Enrollment of HIV-infected subjects for population PK study groups was not halted due to the lack of HIV-infected children in the study area. Comparisons of AL PK exposure were made among and between a) HIV-infected children with malaria receiving EFV-based ART and b) HIV-uninfected children who are not on ART. Comparisons were based on an intensive PK design for AL area under the concentration-time curve (AUC) estimations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This is a prospective multi-site study accomplished through a randomized design where children will be randomized to either 3-day or 5-day AL regimen and then for subsequent episodes of malaria, should they occur..
| Arm | Type | Receives |
|---|---|---|
| HIV-infected 3-day AL | Active comparator | Drug: Artemether-lumefantrineStandard 3-day twice daily (BID) regimen of artemether-lumefantrine for uncomplicated malaria, given over 4 days (Study Days 0, 1, 2 and 3) so that sampling will begin in the morning of day 3. These participants are HIV-infected and stabilized on EFV-based ART. |
| HIV-infected 5-day AL | Experimental | Drug: Artemether-lumefantrineExtended 5-day BID regimen of artemether-lumefantrine, given over 6 days (Study Days 0, 1, 2, 3, 4, and 5) so that sampling will begin in the morning of day 5. These participants are HIV-infected and stabilized on EFV-based ART. |
| HIV-uninfected 3-day AL | Active comparator | Drug: Artemether-lumefantrineStandard 3-day BID regimen of artemether-lumefantrine for uncomplicated malaria, given over 4 days (Study Days 0, 1, 2 and 3) so that sampling will begin in the morning of day 3. These participants are HIV-uninfected. |
| HIV-uninfected 5-day AL | Experimental | Drug: Artemether-lumefantrineExtended 5-day BID regimen of artemether-lumefantrine, given over 6 days (Study Days 0, 1, 2, 3, 4, and 5) so that sampling will begin in the morning of day 5. These participants are HIV-uninfected. |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (14 listed)
- 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)
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Artemether-lumefantrineAlso: Coartem, ALChildren will receive the dispersible formulation of AL which contains 20 mg artemether, 120 mg of lumefantrine (Coartem® Dispersible). Weight-based dosing will be as below: <15kg, 1tablet; 15-25kg, 2 tablets; 25-35kg, 3 tablets; >=35kg, 4 tablets. | Drug | HIV-infected 3-day AL, HIV-infected 5-day AL, HIV-uninfected 3-day AL, HIV-uninfected 5-day AL |
Primary outcome
AUC0-21d
Time frame: Study day 0-day21
Area under the plasma concentration versus time curve (AUC) from time 0 to day 21 for lumefantrine
Recurrent Parasitemia Following Treatment by Day 42 (Recrudescence or New Infection)
Time frame: up to study day 42
Recurrent malaria determined by microscopy (thick blood smears), loop mediated isothermal amplification (LAMP), or rapid diagnostic test (RDT).
AUC0-8h for Artemether
Time frame: 0-8hr
Area under the plasma concentration versus time curve (AUC) from 0 to 8hr post last dose for artemether (ARM)
AUC0-8h for Dihydroartemisinin
Time frame: 0-8hr
Area under the plasma concentration versus time curve (AUC) from time 0 to 8hr post last dose for Dihydroartemisinin (DHA)
Cmax for Lumefantrine
Time frame: 0-21 days
Maximal concentration post last dose for lumefantrine
Cmax for Artemether
Time frame: 0-8hr
Maximal concentration post last dose for artemether
Cmax for Dihydroartemisinin
Time frame: 0-8hr
Maximal concentration post last dose for dihydroartimisinin (DHA)
1 secondary outcome
Number of Participants With Serious Adverse Events
Time frame: study day 0-42
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 36130191Whalen ME, Kajubi R, Goodwin J, Orukan F, Colt M, Huang L, Richards K, Wang K, Li F, Mwebaza N, Aweeka FT, Parikh S. The Impact of Extended Treatment With Artemether-lumefantrine on Antimalarial Exposure and Reinfection Risks in Ugandan Children With Uncomplicated Malaria: A Randomized Controlled Trial. Clin Infect Dis. 2023 Feb 8;76(3):443-452. doi: 10.1093/cid/ciac783.
- Results publication: PubMed 39853752Whalen ME, Kajubi R, Goodwin J, Orukan F, Colt M, Huang L, Richards K, Hoffmann TJ, Aweeka FT, Parikh S, Mwebaza N. Extended Treatment Duration of Artemether-Lumefantrine in Ugandan Children with HIV on Efavirenz-Based Antiretroviral Therapy: A Randomized Controlled Pharmacokinetic and Pharmacodynamic Trial. J Clin Pharmacol. 2025 Jul;65(7):909-922. doi: 10.1002/jcph.6193. Epub 2025 Jan 24.
- Derived from this study: PubMed 38714692Goodwin J, Kajubi R, Wang K, Li F, Wade M, Orukan F, Huang L, Whalen M, Aweeka FT, Mwebaza N, Parikh S. Persistent and multiclonal malaria parasite dynamics despite extended artemether-lumefantrine treatment in children. Nat Commun. 2024 May 7;15(1):3817. doi: 10.1038/s41467-024-48210-7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesca Aweeka, Pharm. D principal investigator
University of California, San Francisco
Sunil Parikh, M.D., MPH principal investigator
Yale University School of Public Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Artemether-lumefantrine in people with Uncomplicated Plasmodium Falciparum Malaria, run by University of California, San Francisco at 2 sites in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC0-21d (time frame: Study day 0-day21). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03453840, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2025.