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Optimizing Malaria Treatment for HIV-Malaria Co-Infected Individuals by Addressing Drug Interactions Between Artemether-Lumefantrine and Efavirenz; a Randomized Controlled Trial (OPTIMAL)
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.
Details
| Lead sponsor | Makerere University |
|---|---|
| Phase | Phase 4 |
| Status | UNKNOWN |
| Enrolment | 888 |
| Start date | 2021-01-18 |
| Completion | 2024-03 |
Conditions
- HIV Coinfection
- Malaria
Interventions
- Artemether-lumefantrine
Primary outcomes
- Measure of malaria treatment outcome adjusted by genotyping and classified as reinfection or recrudescence. — Day 42
The Primary outcome measure will be the malaria treatment outcome adjusted by genotyping and classified as reinfection or recrudescence. Treatment outcomes will be classified on the basis of an assessment of the parasitological and clinical outcomes of antimalarial treatment according to the latest WHO guidelines. Thus, all patients will be classified as having early treatment failure, late clinical failure, late parasitological failure or an adequate clinical and parasitological response. Clinical Treatment outcomes will be assessed according to WHO criteria as; early treatment failure and late treatment failure. Parasitological treatment outcomes will be classified as late parasitological failure and adequate clinical and parasitological response.
Countries
Uganda