drugset / Trial / NCT04708496

Optimizing Malaria Treatment for HIV-Malaria Co-infected Individuals

NCT04708496

Phase 4 Unknown 888 enrolled Makerere University
RandomizedParallel-groupSingle-blindTreatment

Summary

Optimal is a Randomized clinical trial to optimize treatment of malaria in HIV -malaria co infected patients. It has been demonstrated that, when the antimalarial drug Artemether Lumefantrine is co administered with Efavirenz based ART in HIV-malaria co-infected individuals, sub therapeutic levels of the drug are achieved hence resulting in poor malaria treatment outcomes. The study then hypothesizes that, : HIV-malaria co-infected individuals receiving efavirenz-based ART plus a double-dose or 5-day course of artemether-lumefantrine will achieve higher and adequate artemether-lumefantrine serum concentrations with adequate 42-day treatment outcomes compared to individuals with HIV-malaria co-infection receiving efavirenz-based ART plus a standard-dose of artemether-lumefantrine.

Timeline

Start
2021-01-18
Primary completion
2024-01
Completion
2024-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Artemether-lumefantrine Unknown

Indications