NCT06967519RecruitingPhase 4
OPTImizing Malaria And HIV Treatment in a Shifting Landscape in Africa
Source: ClinicalTrials.gov · Last updated 4 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 380 (estimated)
- First submitted
- 23 Apr 2025
- Start date
- 18 Dec 2025
- Primary completion date
- Dec 2027
- Lead sponsor
- Yale University
- Diseases
- HIV
- NCT number
- NCT06967519
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 380
- From 18 Dec 2025 to the primary completion date, Dec 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receipt of known CYP interacting drugs at enrolment (except HAART) - see list of disallowed medications
- Prior intolerance to AL or AS-AQ (for those in Busia only)
- Concurrent enrolment in another research study
Other illness
- Significant comorbidities such as malignancy, active TB, chronic/active hepatitis B/C, diabetes, severe acute malnutrition, mitochondrial disorders
Age
- Pregnancy at enrolment (testing done at enrollment for all those of child-bearing age)
Other
- Anemia defined by hemocue (Hb \< 7.0) at the time of enrolment
- Signs of uncomplicated or severe malaria at the time of enrollment
Who the study is looking for
- 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
Age in the registry: 5 years to 17 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Infectious Disease Research Collaboration (IDRC) Coordinator of this site? Confirm its status | Kampala | Uganda | Recruiting |
| Baylor- Uganda Coordinator of this site? Confirm its status | Kampala | Uganda | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.