drugset / Trial / NCT04009343
Pharmacokinetics and Pharmacodynamics of the Gametocytocidal and Post-treatment Chemoprotective Effects of Antimalarials
Phase 2/3
Active not recruiting
182 enrolled
Johns Hopkins Bloomberg School of Public Health
Tropical Diseases Research Centre · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
Single-center phase II/III clinical investigation of the pharmacokinetics and pharmacodynamics of artemether-lumefantrine and dihydroartemisinin-piperaquine for gametocyte clearance and post-treatment chemoprotection in Zambian children with uncomplicated falciparum malaria.
Timeline
- Start
- 2019-06-19
- Primary completion
- 2020-08-24
- Completion
- 2026-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ARTENIMOL | Small molecule | 20 mg | — |
| Subject | ARTENIMOL | Small molecule | 30 mg | — |
| Subject | ARTENIMOL | Small molecule | 40 mg | — |
| Subject | ARTENIMOL | Small molecule | 60 mg | — |
| Comparator | Artemether | Small molecule | 20 mg | — |
| Comparator | Artemether | Small molecule | 40 mg | — |
| Comparator | lumefantrine | Small molecule | 120 mg | — |
| Comparator | lumefantrine | Small molecule | 240 mg | — |
| Subject | piperaquine | Small molecule | 160 mg | — |
| Subject | piperaquine | Small molecule | 240 mg | — |
| Subject | piperaquine | Small molecule | 320 mg | — |
| Subject | piperaquine | Small molecule | 480 mg | — |