OPTImizing Malaria And HIV Treatment in a Shifting Landscape in Africa
Recruiting · NCT06967519 · Interventional (participants receive a specific treatment) · Lead sponsor: Yale University
View the official record on ClinicalTrials.gov →Interventions studied
Artemether-lumefantrine (AL)artesunate-amodiaquine (AS-AQ)
What this trial is about
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.
Who can take part
Age range
5 Years to 17 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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
Where it is running
2 locations listed.
- Baylor- Uganda - Kampala, Uganda
- Infectious Disease Research Collaboration (IDRC) - Kampala, Uganda