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OPTImizing Malaria And HIV Treatment in a Shifting Landscape in Africa

NCT06967519 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 380

Last updated 2026-02-04

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Yale University

    lead OTHER

Principal Investigators

  • Sunil Parikh, M.D., MPH · Yale School of Public Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-12-18
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • Uganda

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06967519 on ClinicalTrials.gov