Optimizing malaria and HIV treatment for children in Busia and Kampala

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The project follows four parallel, age-matched cohorts of children — HIV-positive on dolutegravir and HIV-negative — at a high-transmission site (Busia) and a low-transmission site (Kampala) for two years. All children enroll malaria-free and are followed longitudinally for malaria episodes, clinical outcomes, body composition, and metabolic measures. In Busia, children are randomized to receive either artemether-lumefantrine or artesunate-amodiaquine for malaria episodes in year one, with one arm switching to alternating regimens in year two; treatment arms may be adjusted if national guidelines change. The study will link dolutegravir exposure, antimalarial pharmacokinetics, and markers of ACT resistance to clinical outcomes for both HIV and malaria.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Principal investigator: Sunil Parikh, M.D., MPH — Yale School of Public Health
• Study coordinator: Sunil Parikh, MD, MPH
• Email: sunil.parikh@yale.edu
• Phone: 1-203-737-7906

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.