[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100590446":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":37,"centralContacts":42,"locations":48,"responsibleParty":72,"collaborators":74,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":85,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":19,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":19,"overallStatus":51,"whyStopped":19,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Yale University","OTHER",[8,15,20,24],{"label":9,"type":10,"description":11,"interventionNames":12},"CLHIV on DTG- Kampala (Cohort 1)","EXPERIMENTAL","CLHIV on DTG living in the low transmission malaria setting of Kampala",[13,14],"Drug: Artemether-lumefantrine (AL)","Drug: artesunate-amodiaquine (AS-AQ)",{"label":16,"type":17,"description":18,"interventionNames":19},"HIV-uninfected children- Kampala (Cohort 2)","NO_INTERVENTION","HIV-uninfected children living in the low malaria transmission site of Kampala (control)",null,{"label":21,"type":10,"description":22,"interventionNames":23},"CLHIV on DTG- Busia (Cohort 3)","CLHIV on DTG living in the high malaria transmission site of Busia",[13,14],{"label":25,"type":17,"description":26,"interventionNames":19},"HIV-uninfected children- Busia (Cohort 4)","HIV-uninfected children living in high malaria transmission site of Busia (control)",[28,33],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":19},"DRUG","Artemether-lumefantrine (AL)","Participants will receive the dispersible formulation of AL with contains 20 mg artemether, 120 mg of lumefantrine",[21,9],{"type":29,"name":34,"description":35,"armGroupLabels":36,"otherNames":19},"artesunate-amodiaquine (AS-AQ)","Children will receive the tablet formulations of Artesunate Amodiaquine using weight based dosing",[21,9],[38],{"name":39,"affiliation":40,"role":41},"Sunil Parikh, M.D., MPH","Yale School of Public Health","PRINCIPAL_INVESTIGATOR",[43],{"name":44,"role":45,"phone":46,"phoneExt":19,"email":47},"Sunil Parikh, MD, MPH","CONTACT","1-203-737-7906","sunil.parikh@yale.edu",[49,64],{"facility":50,"status":51,"city":52,"state":19,"zip":19,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Baylor- Uganda","RECRUITING","Kampala","Uganda","UG",{"type":56,"coordinates":57},"Point",[58,59],32.58219,0.31628,{"lat":59,"lon":58},[62],{"name":63,"role":41,"phone":19,"phoneExt":19,"email":19},"Peter J Elyanu, MD, PhD",{"facility":65,"status":51,"city":52,"state":19,"zip":19,"country":53,"countryCode":54,"cosmosGeoPoint":66,"geoPoint":68,"contacts":69},"Infectious Disease Research Collaboration (IDRC)",{"type":56,"coordinates":67},[58,59],{"lat":59,"lon":58},[70],{"name":71,"role":41,"phone":19,"phoneExt":19,"email":19},"Norah Mwebaza, DPPM, PhD",{"type":73,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR",[75],{"name":76,"class":77},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","NIH","100590446","phase-4-optimizing-malaria-and-hiv-treatment-in-a-shifting-landscape-in-africa-100590446",false,"NCT06967519","OPTImizing Malaria And HIV Treatment in a Shifting Landscape in Africa","OPTIMAH","Inclusion Criteria:\n\n* Agreement to come to the clinic for all follow-up evaluations\n* Provision of informed consent and assent (as appropriate)\n* Residency within approximately 30 km of the study clinic\n* Negative blood smear for malaria (all sites)\n* For Children and adolescents living with HIV\n\n  * Confirmed HIV infection\n  * On DTG-based regimen for ≥14 days\n* For HIV-uninfected children - documentation of HIV-negative status by at least 1 assay\n\nExclusion Criteria:\n\n* Significant comorbidities such as malignancy, active TB, chronic\u002Factive hepatitis B\u002FC, diabetes, severe acute malnutrition, mitochondrial disorders\n* Receipt of known CYP interacting drugs at enrolment (except HAART) - see list of disallowed medications\n* Anemia defined by hemocue (Hb \\\u003C 7.0) at the time of enrolment\n* Signs of uncomplicated or severe malaria at the time of enrollment\n* Prior intolerance to AL or AS-AQ (for those in Busia only)\n* Pregnancy at enrolment (testing done at enrollment for all those of child-bearing age)\n* Concurrent enrolment in another research study",true,"ALL","5 Years","17 Years",{"count":90,"type":91},380,"ESTIMATED","INTERVENTIONAL",[94],"PHASE4","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.",[97,98],"Malaria","Hiv","2026-02-02",{"date":101,"type":102},"2026-02-04","ACTUAL",{"date":104,"type":102},"2025-12-18",{"date":106,"type":91},"2027-12",{"name":5,"class":6},2]