About this trial
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 criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Artemether-lumefantrine (AL)
- artesunate-amodiaquine (AS-AQ)
Treatment groups
Sponsors and collaborators
Yale University
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator