OPTImizing Malaria And HIV Treatment in a Shifting Landscape in Africa
Recruiting now · Phase 4
Conditions studied: Malaria, Hiv
In brief
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.
Key facts
- Study ID
- NCT06967519
- Run by
- Yale University
- People needed
- 380
- Starts
- 2025-12-18
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2026-02-04
Who can join
Age: 5 and older, up to 17. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
- Baylor- Uganda — Kampala, Uganda (enrolling)
- Infectious Disease Research Collaboration (IDRC) — Kampala, Uganda (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.