OPTImizing Malaria And HIV Treatment in a Shifting Landscape in Africa

Launched by YALE UNIVERSITY · May 2, 2025

Keywords

ClinConnect Summary

The clinical trial titled "OPTImizing Malaria And HIV Treatment in a Shifting Landscape in Africa" is designed to study how malaria and HIV affect children in different areas of Africa. Researchers will follow two groups of children living with HIV and two groups of HIV-uninfected children for two years, comparing those from a high malaria transmission area in Busia with those from a low transmission area in Kampala. All children will start the study healthy, with no malaria infection.

To be eligible for the trial, participants must live within about 30 kilometers of the study clinic and agree to attend all follow-up visits. Children living with HIV need to have a confirmed infection and be on a specific HIV treatment for at least 14 days, while HIV-uninfected children must have proof of their HIV-negative status. Participants can expect regular check-ups over the two years, and it's important to know that certain health conditions or medications may prevent someone from joining the study. This research aims to improve treatment strategies for children facing these challenging health issues.

Gender

ALL

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