RecruitingPhase 4NCT06967519

OPTImizing Malaria And HIV Treatment in a Shifting Landscape in Africa


Sponsor

Yale University

Enrollment

380 participants

Start Date

Dec 18, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 5 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating how to optimize malaria treatment in African children and adolescents living with HIV who are on dolutegravir-based HIV therapy — to ensure both diseases are treated effectively without the treatments interfering with each other. **You may be eligible if...** - You are a child or adolescent living with HIV and are currently on a dolutegravir-based HIV regimen for at least 14 days - You have tested negative for malaria at enrollment - You live within approximately 30 km of the study clinic - You and/or your guardian have given consent to participate and attend all follow-up visits - OR: You are an HIV-uninfected child with documented negative HIV status **You may NOT be eligible if...** - You have significant other illnesses such as active tuberculosis, cancer, hepatitis B/C, diabetes, or severe malnutrition - You cannot commit to follow-up visits Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGArtemether-lumefantrine (AL)

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

DRUGartesunate-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

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NCT06967519


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