drugset / Trial / NCT06967519
OPTImizing Malaria And HIV Treatment in a Shifting Landscape in Africa
Phase 4
Recruiting
380 enrolled
Yale University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
A longitudinal study with four parallel cohorts with each participant followed for 2 years: two cohorts in Busia (high malaria transmission site) and two cohorts in Kampala (low malaria transmission). Each site will have a cohort of children living with HIV (CLHIV) and HIV- uninfected children and will be age-matched, enrolled in parallel, and followed for two years. All children will be enrolled without malaria infection, as determined by a negative blood smear at baseline.
Timeline
- Start
- 2025-12-18
- Primary completion
- 2027-12
- Completion
- 2027-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Artemether | Small molecule | 20 mg | — |
| Subject | Artesunate | Small molecule | — | — |
| Subject | amodiaquine | Other / unclassified | — | — |
| Subject | lumefantrine | Small molecule | 120 mg | — |