Status:
NOT_YET_RECRUITING
OPTImizing Malaria And HIV Treatment in a Shifting Landscape in Africa
Lead Sponsor:
Yale University
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Malaria
Hiv
Eligibility:
All Genders
5-17 years
Phase:
PHASE4
Brief 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)....
Detailed Description
CLHIV will be maintained on a dolutegravir (DTG) based regimen for \>2 weeks prior to enrolment to ensure steady state. All children in Busia (HIV-infected and HIV-uninfected) will be enrolled and the...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
380 Patients enrolled
Trial Details
Trial ID
NCT06967519
Start Date
December 1 2025
End Date
December 1 2027
Last Update
October 30 2025
Active Locations (2)
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1
Baylor- Uganda
Kampala, Uganda
2
Infectious Disease Research Collaboration (IDRC)
Kampala, Uganda