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OPTImizing Malaria And HIV Treatment in a Shifting Landscape in Africa

RecruitingPhase 4

Sponsor: Yale University

Conditions: Malaria, Hiv

Interventions: Artemether-lumefantrine (AL), artesunate-amodiaquine (AS-AQ)

Countries: Uganda

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 overview

Sex: ALL

Age: 5 Years to 17 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (2)

Kampala, Uganda
Kampala, Uganda