NCT06967519 OPTImizing Malaria And HIV Treatment in a Shifting Landscape in Africa
| NCT ID | NCT06967519 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Yale University |
| Condition | Malaria |
| Study Type | INTERVENTIONAL |
| Enrollment | 380 participants |
| Start Date | 2025-12-18 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 380 participants in total. It began in 2025-12-18 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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). 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 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
Contact & Investigator
Sunil Parikh, M.D., MPH
PRINCIPAL INVESTIGATOR
Yale School of Public Health
Frequently Asked Questions
Who can join the NCT06967519 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, up to 17 Years, studying Malaria. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06967519 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06967519 currently recruiting?
Yes, NCT06967519 is actively recruiting participants. Contact the research team at sunil.parikh@yale.edu for enrollment information.
Where is the NCT06967519 trial being conducted?
This trial is being conducted at Kampala, Uganda, Kampala, Uganda.
Who is sponsoring the NCT06967519 clinical trial?
NCT06967519 is sponsored by Yale University. The principal investigator is Sunil Parikh, M.D., MPH at Yale School of Public Health. The trial plans to enroll 380 participants.