OPTImizing Malaria And HIV Treatment in a Shifting Landscape in Africa
Yale University
380 participants
Dec 18, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria8
- Agreement to come to the clinic for all follow-up evaluations
- Provision of informed consent and assent (as appropriate)
- Residency within approximately 30 km of the study clinic
- Negative blood smear for malaria (all sites)
- For Children and adolescents living with HIV
- Confirmed HIV infection
- On DTG-based regimen for ≥14 days
- For HIV-uninfected children - documentation of HIV-negative status by at least 1 assay
Exclusion Criteria7
- Significant comorbidities such as malignancy, active TB, chronic/active hepatitis B/C, diabetes, severe acute malnutrition, mitochondrial disorders
- Receipt of known CYP interacting drugs at enrolment (except HAART) - see list of disallowed medications
- Anemia defined by hemocue (Hb \< 7.0) at the time of enrolment
- Signs of uncomplicated or severe malaria at the time of enrollment
- Prior intolerance to AL or AS-AQ (for those in Busia only)
- Pregnancy at enrolment (testing done at enrollment for all those of child-bearing age)
- Concurrent enrolment in another research study
Interventions
Participants will receive the dispersible formulation of AL with contains 20 mg artemether, 120 mg of lumefantrine
Children will receive the tablet formulations of Artesunate Amodiaquine using weight based dosing
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06967519