[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University of Nairobi\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":96},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,68],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":25,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100574651","investigating-the-optimal-management-of-dolutegravir-resistance-100574651",false,"NCT06762054","Investigating the Optimal Management of Dolutegravir Resistance","Investigating the Optimal Management of Dolutegravir Resistance: a Multi-country Cohort Study","Inclusion Criteria:\n\n* Able and willing to provide informed consent (assent as appropriate and legal guardian consent if \\\u003C 18 years)\n* Age ≥ 1 years\n* Documented HIV-1 infection as confirmed by national HIV testing standards at the respective study sites\n* On a DTG-based ART regimen for at least six months\n* Most recent HIV-1 RNA ≥ 1,000 copies\u002FmL within 3 months prior to enrolment, taken after at least 6 months on current ART regimen\n\nExclusion Criteria:\n\n* Has switched ART regimen for confirmed or suspected HIV treatment failure while on a PI- or INSTI-based regimen\n* Any reason which, in the investigator's opinion, will significantly prevent the collection of viral load levels such as relocation to another area outside of the trial sites or imminent death\n* Concomitant NNRTI or PI while on DTG","ALL","1 Year",{"count":19,"type":20},6600,"ESTIMATED","OBSERVATIONAL","The goal of this study is to address the gap in published data on viral suppression among people meeting the criteria for virologic failure on dolutegravir (DTG)-based ART regimens without a change in regimen. The study will also assess the emergence of DTG-associated drug-resistant mutations and their impact on viral suppression.",[24],"HIV-1-infection",[26,27,28,29,30,31],"HIV","Dolutegravir","Treatment failure","Drug resistant mutations","Dolutegravir resistance","Re-suppression","RECRUITING","2025-09-04",{"date":35,"type":36},"2025-09-05","ACTUAL",{"date":38,"type":36},"2025-03-03",{"date":40,"type":20},"2026-10",{"name":42,"class":43},"University of Nairobi","OTHER",9,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":60,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":44},"100573532","phase-3-ndovu-rct-investing-the-optimal-management-of-dolutegravir-resistance-100573532","NCT06747507","Ndovu RCT: Investing the Optimal Management of Dolutegravir Resistance","Investigating the Optimal Management of Dolutegravir Resistance: an Open-label Randomised Controlled Trial of Maintaining Dolutegravir or Switch to Ritonavir-boosted Darunavir","Inclusion Criteria:\n\n* Enrolled in the Ndovu cohort study\n* Able and willing to understand and comply with the protocol requirements, instructions and restrictions\n* Able and willing to provide informed consent for the nested clinical trial (assent as appropriate and legal guardian consent if \\\u003C 18 years)\n* Age ≥ 3 years\n* Most recent HIV-1 RNA ≥ 200 copies\u002FmL\n* At least one major DTG-associated DRM (substitution at codon 66K, 92Q, 118R, 138K\u002FA\u002FT, 140S\u002FA\u002FC, 148H\u002FR\u002FK, 155H or 263K)\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding\n* Using any concomitant therapy disallowed as per the reference safety information and product labelling for the study drugs\n* WHO stage 3 or 4 opportunistic infection which would prevent randomisation to either arm (e.g. due to drug interactions or significant liver or renal injury) within 4 weeks prior to RCT screening\n* Investigator opinion that the potential participant should discontinue DTG immediately for clinical reasons\n* Investigator opinion that the potential participant should not switch to DRV\u002Fr for clinical reasons","3 Years",{"count":54,"type":20},392,"INTERVENTIONAL",[57],"PHASE3","This clinical trial will address the gap in published data on the effect of dolutegravir (DTG)-associated drug-resistant mutations on viral suppression among people remaining on DTG-based antiretroviral therapy. It will also address the gap in the optimal management strategy for this population.",[24],[26,27,28,29,30,31],{"date":62,"type":36},"2025-09-11",{"date":64,"type":36},"2025-09-01",{"date":66,"type":20},"2027-07",{"name":42,"class":43},{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":4,"studyType":55,"phases":80,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},"100535107","psychoeducation-relaxation-problem-solving-activation-cognitive-coping-therapy-for-adolescents-and-youth-in-hiv-care-100535107","NCT06247527","Psychoeducation, Relaxation, PrOblem Solving, Activation, Cognitive Coping Therapy for Adolescents and Youth in HIV Care","Integrating a Transdiagnostic Psychological Intervention In The Care For Adolescents And Youth With HIV In Kenya","PROACT","Inclusion Criteria:\n\n* Adolescent or youth ages 16-24 years attending HIV clinic at selected site with at least mild psychological distress who is willing to join the study and capable of providing consent to receive the intervention\n\nExclusion Criteria:\n\n* If any study procedure would put them at an increased risk or if their compliance with study procedures is not possible","16 Years","24 Years",{"count":79,"type":20},600,[81],"NA","The proposed PROACT study will test the effectiveness of a mental health intervention (psychotherapy) for multiple common mental health conditions (depressive, anxiety and trauma symptoms) among adolescents and youth with HIV in Kenya. The study will also evaluate key factors for successful intervention implementation and conduct an economic evaluation to inform future intervention scale-up.",[84,85,24],"Depression, Anxiety","Trauma","NOT_YET_RECRUITING","2024-02-06",{"date":89,"type":36},"2024-02-08",{"date":91,"type":20},"2024-05",{"date":93,"type":20},"2028-05",{"name":42,"class":43},1,""]