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RECRUITINGPhase 4INTERVENTIONAL

OPTImizing Malaria And HIV Treatment in a Shifting Landscape in Africa

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Agreement to come to the clinic for all follow-up evaluations - Provision of willing to sign a consent form 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Artemether-lumefantrine (AL)

Participants will receive the dispersible formulation of AL with contains 20 mg artemether, 120 mg of lumefantrine

DRUG

artesunate-amodiaquine (AS-AQ)

Children will receive the tablet formulations of Artesunate Amodiaquine using weight based dosing

Locations (2)

Baylor- Uganda
Kampala, Uganda
Infectious Disease Research Collaboration (IDRC)
Kampala, Uganda