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| ID | Type | Description | Link |
|---|---|---|---|
| 2R01HD068174-06A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
| Yale University | OTHER |
| Infectious Diseases Research Collaboration, Uganda | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Artemether-lumefantrine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-21d | Area under the plasma concentration versus time curve (AUC) from time 0 to day 21 for lumefantrine | 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). | 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) | 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) | 0-8hr |
| Cmax for Lumefantrine | Maximal concentration post last dose for lumefantrine | 0-21 days |
| Cmax for Artemether | Maximal concentration post last dose for artemether | 0-8hr |
| Cmax for Dihydroartemisinin | Maximal concentration post last dose for dihydroartimisinin (DHA) | 0-8hr |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Serious Adverse Events | We recorded participants tolerance of AL using the NIH Division of AIDS Adult and Pediatric Toxicity Tables. | study day 0-42 |
| Measure | Description | Time Frame |
|---|---|---|
| Relationship Between Drug Resistance and Treatment Failure | drug resistance will be accessed by molecular markers. Polymorphic markers will be typed using capillary electrophoresis. | study day 0-42 |
| Metabolomic Measurements in HIV Infected vs HIV Uninfected Children |
Inclusion Criteria:
1, All participants:
2 HIV-infected participants:
3 HIV-uninfected participants:
Exclusion Criteria:
The following medications are disallowed within 3 weeks prior to receiving study drug:
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| Name | Affiliation | Role |
|---|---|---|
| Francesca Aweeka, Pharm. D | University of California, San Francisco | Principal Investigator |
| Sunil Parikh, M.D., MPH | Yale University School of Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MGH campus | Busia | Uganda | ||||
| IDRC- Tororo Research Clinic and Tororo District Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36130191 | Result | 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. | |
| 39853752 | Result | Whalen 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. |
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The recruitment started on 2/21/2018 and ended on 07/23/2019 and last follow up date was 09/03/2019. Study location was at Masafu General Hospital. Intensive PK recruitments were completed for all 4 arms: HIV negative 3-day and 5-day arm (n=50 each), HIV positive 3-day and 5-day arm (n=30). Population PK recruitments reached the target for HIV negative arms (n=60 each), but not for HIV-positive arms, because of the lack of HIV positive patients in the study sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | HIV-infected 3-day AL | 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. Artemether-lumefantrine: 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. |
| FG001 | HIV-infected 5-day AL | 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. Artemether-lumefantrine: 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. |
| FG002 | HIV-uninfected 3-day AL | 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. Artemether-lumefantrine: 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. |
| FG003 | HIV-uninfected 5-day AL | 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. Artemether-lumefantrine: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Eligible HIV negative participant age range is 6 months to 18 years and HIV positive participant age range 3-18 years.
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| ID | Title | Description |
|---|---|---|
| BG000 | HIV-infected 3-day AL Intensive PK | 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. Artemether-lumefantrine: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | AUC0-21d | Area under the plasma concentration versus time curve (AUC) from time 0 to day 21 for lumefantrine | Intensive PK participants only. Population PK participants are excluded here. | Posted | Geometric Mean | 95% Confidence Interval | hr*ug/mL | Study day 0-day21 |
|
days 0 to 42
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HIV-infected 3-day AL | 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. Artemether-lumefantrine: 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hypoglycemia | Blood and lymphatic system disorders | Systematic Assessment | hypoglycemia on day 26 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Liusheng Huang (Co-Investigator and Drug Research Unit Co-Director) | University of California San Francisco | 415-502-2594 | liusheng.huang@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 19, 2018 | Jul 22, 2021 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form: Informed Consent Forms | Sep 18, 2019 | Jul 22, 2021 | ICF_003.pdf |
| ICF | No | No | Yes | Informed Consent Form: Assent and consent for future use of specimen | Sep 18, 2019 | Jul 22, 2021 | ICF_004.pdf |
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| ID | Term |
|---|---|
| D008288 | Malaria |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
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| ID | Term |
|---|---|
| D000077611 | Artemether, Lumefantrine Drug Combination |
| ID | Term |
|---|---|
| D000077549 | Artemether |
| D037621 | Artemisinins |
| D017382 | Reactive Oxygen Species |
| D005609 | Free Radicals |
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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..
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|
|
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. |
| study day 0-42 |
| Height-for-age (HFA) Associations With PK | chronic protein-calorie malnutrition resulting in slow linear growth (decreased height-for-age: HFA; stunting). | study day 0 |
| Diagnostic Sensitivity of LAMP, HS-RDT, and Microscopy for the Detection of Recurrent Parasitemia | Using Loop-mediated isothermal amplification (LAMP), highly sensitive Rapid Diagnostic Test (HS-RDT), and microscope to diagnose recurrent parasitemia. study day 0-42 | study day 0-42 |
| Weight-for-height (WFH) Associations With PK | acute protein-calorie malnutrition resulting in weight loss or slow weight gain (decreased weight-for-height: WFH; wasting). | study day 0 |
| Weight-for-age (WFA) Associations With PK | weight-for-age is an indicator of nutrition status and decreased weight-for-age reflects the combination of chronic and acute protein-calorie malnutrition. | study day 0 |
| Prevalence of Gametocytemia | At varied time points, blood smears for the determination of parasitemia will be obtained following treatment in 3-day vs 5-day AL regimens. | study day 0-42 |
| Tororo |
| Uganda |
| 38714692 | Derived | Goodwin 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. |
| BG001 | HIV-infected 5-day AL Intensive PK | 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. Artemether-lumefantrine: 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. |
| BG002 | HIV-uninfected 3-day AL | 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. Artemether-lumefantrine: 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. |
| BG003 | HIV-uninfected 5-day AL | 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. Artemether-lumefantrine: 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. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Median | Inter-Quartile Range | kg |
|
| OG001 | HIV-infected 5-day AL Intensive PK | 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. Artemether-lumefantrine: 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. |
| OG002 | HIV-uninfected 3-day AL Intensive PK | 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. Artemether-lumefantrine: 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. |
| OG003 | HIV-uninfected 5-day AL Intensive PK | 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. Artemether-lumefantrine: 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. |
|
|
| Primary | 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). | All participants including intensive and population PK participants. | Posted | Count of Participants | Participants | up to study day 42 |
|
|
|
| Primary | AUC0-8h for Artemether | Area under the plasma concentration versus time curve (AUC) from 0 to 8hr post last dose for artemether (ARM) | 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. | Posted | Geometric Mean | 95% Confidence Interval | hr*ng/mL | 0-8hr |
|
|
|
| Primary | AUC0-8h for Dihydroartemisinin | Area under the plasma concentration versus time curve (AUC) from time 0 to 8hr post last dose for Dihydroartemisinin (DHA) | 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. | Posted | Geometric Mean | 95% Confidence Interval | hr.ng/mL | 0-8hr |
|
|
|
| Primary | Cmax for Lumefantrine | Maximal concentration post last dose for lumefantrine | Posted | Geometric Mean | 95% Confidence Interval | ng/mL | 0-21 days |
|
|
|
| Primary | Cmax for Artemether | Maximal concentration post last dose for artemether | Posted | Geometric Mean | 95% Confidence Interval | ng/mL | 0-8hr |
|
|
|
| Primary | Cmax for Dihydroartemisinin | Maximal concentration post last dose for dihydroartimisinin (DHA) | Posted | Geometric Mean | 95% Confidence Interval | ng/mL | 0-8hr |
|
|
|
| Secondary | Number of Participants With Serious Adverse Events | We recorded participants tolerance of AL using the NIH Division of AIDS Adult and Pediatric Toxicity Tables. | Posted | Count of Participants | Participants | study day 0-42 |
|
|
|
| Other Pre-specified | Relationship Between Drug Resistance and Treatment Failure | drug resistance will be accessed by molecular markers. Polymorphic markers will be typed using capillary electrophoresis. | Not Posted | study day 0-42 | Participants |
| Other Pre-specified | Metabolomic Measurements in HIV Infected vs HIV Uninfected Children | 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. | Not Posted | study day 0-42 | Participants |
| Other Pre-specified | Height-for-age (HFA) Associations With PK | chronic protein-calorie malnutrition resulting in slow linear growth (decreased height-for-age: HFA; stunting). | Not Posted | study day 0 | Participants |
| Other Pre-specified | Diagnostic Sensitivity of LAMP, HS-RDT, and Microscopy for the Detection of Recurrent Parasitemia | Using Loop-mediated isothermal amplification (LAMP), highly sensitive Rapid Diagnostic Test (HS-RDT), and microscope to diagnose recurrent parasitemia. study day 0-42 | Not Posted | study day 0-42 | Participants |
| Other Pre-specified | Weight-for-height (WFH) Associations With PK | acute protein-calorie malnutrition resulting in weight loss or slow weight gain (decreased weight-for-height: WFH; wasting). | Not Posted | study day 0 | Participants |
| Other Pre-specified | Weight-for-age (WFA) Associations With PK | weight-for-age is an indicator of nutrition status and decreased weight-for-age reflects the combination of chronic and acute protein-calorie malnutrition. | Not Posted | study day 0 | Participants |
| Other Pre-specified | Prevalence of Gametocytemia | At varied time points, blood smears for the determination of parasitemia will be obtained following treatment in 3-day vs 5-day AL regimens. | Not Posted | study day 0-42 | Participants |
| 0 |
| 35 |
| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | HIV-infected 5-day AL | 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. Artemether-lumefantrine: 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. | 0 | 36 | 0 | 36 | 0 | 36 |
| EG002 | HIV-uninfected 3-day AL | 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. Artemether-lumefantrine: 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. | 0 | 114 | 2 | 114 | 0 | 114 |
| EG003 | HIV-uninfected 5-day AL | 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. Artemether-lumefantrine: 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. | 0 | 113 | 0 | 113 | 0 | 113 |
|
| anemia | Blood and lymphatic system disorders | Systematic Assessment | grade 4 anemia on day 28 |
|
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| D000079426 |
| Vector Borne Diseases |
| D007287 |
| Inorganic Chemicals |
| D009930 | Organic Chemicals |
| D000078102 | Lumefantrine |
| D005449 | Fluorenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D012717 | Sesquiterpenes |
| D013729 | Terpenes |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |