[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Kenya\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":687},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,118,0,25,[9,51,80,102,134,160,181,212,231,261,286,324,349,376,398,423,448,478,499,525,549,575,605,641,664],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":18,"sex":19,"minAge":20,"maxAge":21,"enrollmentInfo":22,"targetDuration":4,"studyType":25,"phases":26,"briefSummary":28,"conditions":29,"keywords":33,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100053887","expanding-coverage-of-severe-acute-malnutrition-sam-treatment-in-kenya-100053887",false,"NCT06441305","Expanding Coverage of Severe Acute Malnutrition (SAM) Treatment in Kenya","Assessing the Impact, Implementation and Cost of Empowering Community Health Promoters to Improve Wasting Treatment Coverage in Turkana County Through Family-led MUAC Scale-up, Weight-for-age Screening, and Defaulters' Follow-up","R-SWITCH","Inclusion Criteria:\n\n* Household in a village of the study area covered by a CHP (although the child may or may not be registered by a CHP) AND\n* Child is 6-59.9 months of age AND\n* Caregiver consents to be part of the study AND\n* any of the following:\n\n  * WHZ \\\u003C -3 (relative to WHO 2006 reference) OR\n  * MUAC \\\u003C115 mm OR\n  * Presence of bilateral edema OR\n  * receiving treatment as follow-up for an initial SAM condition on the way to full recovery\n\nexclusion criteria is:\n\n* Congenital malformation that makes anthropometric measurements impossible.\n* Length is below 54 cm or height is above 120cm.",true,"ALL","6 Months","5 Years",{"count":23,"type":24},1600,"ESTIMATED","INTERVENTIONAL",[27],"NA","Child wasting is a type of malnutrition which occurs when a child becomes too thin. This medical condition increases the risk of becoming sick or dying. A child with severe wasting needs to be seen in a medical consultation to check on health status and to receive some medicine and a medical food supplement for daily consumption until cured. Yet, only a small proportion of children suffering from severe wasting are presently receiving appropriate treatment.\n\nIn Kenya, there is an opportunity to build on the existing network of community health promoters (CHPs) to increase the number of children with wasting who are identified and treated. In intervention areas, CHPs will be equipped with smartphones and an application which provides guidance on household members to visit and simple actions to take, related to health. CHPs will distribute color-coded mid-upper arm circumference tapes to households with young children and train caregivers on how to use it. After training, CHPs will send Short Message Services (SMS) to remind caregivers to regularly measure the arm circumference of the child. In addition, CHPs will receive a scale to measure the weight of children every month. Finally, wasted children registered in the treatment program who fail to attend a planned consultation will be flagged to their CHP through the phone application, and CHPs will conduct a specific home visit to investigate and help solve potential issues.\n\nThe study will assess whether this community intervention (called SWITCH) allows to identify and treat more children suffering from severe wasting. Before the start of the intervention, the proportion of wasted children receiving treatment in 40 community units in Turkana South, Turkana East and Aroo will be assessed. After this survey, a computer will randomly select 20 community units where the intervention will be scaled up. The survey will be repeated after 2 years to assess if the proportion of severely wasted children receiving treatment is higher in the area where the intervention was scaled up compared to the area where it was not scaled up.\n\nIn addition, after 1 year of implementation, the study will assess how the intervention was scaled up, what are the main challenges, and what are the overall perceptions on the intervention in the community among those who receive it and those who deliver it. Finally, costs of the various components of the intervention will be measured for all actors involved, including for caregivers.",[30,31,32],"Acute Malnutrition, Severe","Malnutrition, Child","Wasting",[34,35,36,32,37],"Outpatient Therapeutic Feeding Program","Treatment","Screening","Severe acute malnutrition","RECRUITING","2026-07-09",{"date":41,"type":42},"2026-07-13","ACTUAL",{"date":44,"type":42},"2024-06-03",{"date":46,"type":24},"2027-07-30",{"name":48,"class":49},"International Food Policy Research Institute","OTHER",1,{"id":52,"slug":53,"hasResults":12,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":12,"sex":19,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":25,"phases":62,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":79},"100506775","phase-3-a-study-to-evaluate-the-long-term-safety-of-astegolimab-in-participants-with-chronic-obstructive-pulmonary-disease-copd-100506775","NCT05878769","A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)","A Phase III Open-Label Extension Study to Evaluate the Long-Term Safety of Astegolimab in Patients With Chronic Obstructive Pulmonary Disease","Inclusion Criteria:\n\n* Completion of the 52-week treatment period in either parent GB43311 or GB44332\n\nExclusion Criteria:\n\n* Withdrawal of consent and\u002For premature discontinuation from parent study\n* Any permanent discontinuation of study drug in parent study\n* Significant non-compliance in the parent study, specifically defined as missing scheduled visits, per investigator's judgment\n* Any new diagnosis of asthma according to the Global Initiative for Asthma guidelines or other accepted guidelines since enrolling in the parent study\n* Any new clinically significant pulmonary disease other than COPD (e.g., pulmonary fibrosis, sarcoidosis, chronic pulmonary embolism or primary pulmonary hypertension, alpha-1-antitrypsin deficiency) since enrolling in the parent study\n* Any new unstable cardiac disease, myocardial infarction, or New York Heart Association Class III or IV heart failure since enrolling in the parent study","40 Years","90 Years",{"count":61,"type":24},2000,[63],"PHASE3","The purpose of this study is to assess the long-term safety and to explore the efficacy of astegolimab in participants with chronic obstructive pulmonary disease (COPD) who have completed the 52-week placebo-controlled treatment period in parent studies GB43311 or GB44332.",[66],"Chronic Obstructive Pulmonary Disease",[68],"chronic obstructive pulmonary disease, COPD","2026-07-01",{"date":71,"type":42},"2026-07-02",{"date":73,"type":42},"2023-06-28",{"date":75,"type":24},"2034-07-01",{"name":77,"class":78},"Hoffmann-La Roche","INDUSTRY",486,{"id":81,"slug":82,"hasResults":12,"nctId":83,"briefTitle":84,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":12,"sex":19,"minAge":87,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":25,"phases":89,"briefSummary":90,"conditions":91,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":101},"100497191","building-respiratory-support-in-east-africa-through-high-flow-versus-standard-flow-oxygen-evaluation-100497191","NCT05754034","Building Respiratory Support in East Africa Through High Flow Versus Standard Flow Oxygen Evaluation","BREATHE","Inclusion Criteria:\n\n* age\\>=18 years AND\n* admitted to a study site hospital within the 24 hours prior to screening AND\n* SpO2\\\u003C90% at time of first assessment OR\n* receiving oxygen at time of first assessment\n\nExclusion Criteria:\n\n* imminent death (high clinical suspicion of death within 24 hours of admission)\n* patient or caregiver refusal of study participation\n* history of chronic respiratory failure (SpO2\\\u003C90% or oxygen dependence for at least three months)\n* anatomical factors precluding the use of nasal cannula\n* intubation or non-invasive ventilation by the clinical team prior to screening for the trial\n* known hypoxemia at transferring facility for \\>48 hours\n* lack of availability of either SFO or HFO devices or supplies at the time of randomization.","18 Years",{"count":23,"type":24},[27],"Acute hypoxemia is common and deadly in resource variable settings. While studies in high income countries (HICs) have indicated a possible benefit to high flow oxygen as compared with standard flow oxygen, rigorous studies in low or lower middle income countries (LMICs) have not been performed. Studies in sepsis have demonstrated that interventions that improve outcomes in one context may actually be neutral or harmful in a different context.\n\nThe goal of this study is to test whether high flow oxygen results in better outcomes for hypoxemic adult patients, as compared with standard flow oxygen, in five LMIC hospitals. The main questions it aims to answer are:\n\n1. For hypoxemic adults in these LMIC study settings, does high flow oxygen or standard flow oxygen result in lower mortality?\n2. What are the facilitators and barriers to using high flow oxygen in these settings?\n3. Does high flow or standard flow oxygen use more oxygen?\n\nParticipants will be randomized to receive either high flow oxygen through a large nasal cannula, or to receive standard flow oxygen, through nasal cannulas, face masks, or non-rebreather masks. Researchers will compare the outcomes for the two groups, to see if one group of patients has better outcomes than the other.\n\nThe study will also examine how much oxygen is used by the two patient groups, as well as other factors relevant to the feasibility of implementation of high flow oxygen in these sites.",[92],"Acute Hypoxemia","2026-06-30",{"date":69,"type":42},{"date":96,"type":42},"2023-10-11",{"date":98,"type":24},"2026-12-31",{"name":100,"class":49},"Beth Israel Deaconess Medical Center",5,{"id":103,"slug":104,"hasResults":12,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":18,"sex":19,"minAge":87,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":25,"phases":112,"briefSummary":113,"conditions":114,"keywords":116,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":133},"100585118","precision-imaging-to-evaluate-kaposi-sarcoma-100585118","NCT06898203","Precision Imaging to Evaluate Kaposi Sarcoma","Precision Imaging to Evaluation Kaposi Sarcoma (PRIME-KS)","PRIME-KS","Inclusion Criteria - Aim 2 (Patients):\n\n* Adults age ≥18 years old\n* Histopathology-confirmed Kaposi Sarcoma\n* At least 3 skin lesions\n* Capable of informed consent\n* On treatment for Kaposi Sarcoma\n\nExclusion Criteria - Aim 2 (Patients):\n\n* Patients not initiating Kaposi Sarcoma treatment\n* Very ill patients requiring hospitalization\n\nInclusion Criteria - Aim 3 (Patients):\n\n* Adults age ≥18 years old\n* Histopathology-confirmed Kaposi Sarcoma\n* Capable of informed consent\n* Initiating treatment for Kaposi Sarcoma\n\nExclusion Criteria - Aim 3 (Patients):\n\n* Patients with Kaposi Sarcoma that participated in Aim 1 or Aim 2\n* Prior or ongoing Kaposi Sarcoma treatment",{"count":111,"type":24},300,[27],"AIMS 2 \\& 3:\n\nIn this study the investigators seek to formally compare reproducibility and accuracy of KS lesion size measurements between SkinScan3D and the current standard of care manual measurement method. The investigators will then test the SS3D device on 100 patients in a variety of real-world practice locations to determine whether the device will be usable, acceptable, appropriate, and feasible in routine care settings.",[115],"Kaposi Sarcoma",[117,115,118,119,120,121,122,123,124],"Global Oncology","Affordable Cancer Technologies","Cancer in People with HIV","Human Centered Design","Discrete Choice Experiment","Medical devices","Low-cost design","Global health","2026-06-29",{"date":69,"type":42},{"date":128,"type":42},"2026-04-10",{"date":130,"type":24},"2029-11-30",{"name":132,"class":49},"Washington University School of Medicine",2,{"id":135,"slug":136,"hasResults":12,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":4,"eligibilityCriteria":140,"healthyVolunteers":18,"sex":141,"minAge":142,"maxAge":143,"enrollmentInfo":144,"targetDuration":4,"studyType":25,"phases":146,"briefSummary":147,"conditions":148,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":159},"100598448","phase-3-a-study-of-mk-8527-to-prevent-human-immunodeficiency-virus-type-1-hiv-1-mk-8527-010-100598448","NCT07071623","A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010)","A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy and Safety of MK-8527 Oral Once-Monthly as HIV-1 Preexposure Prophylaxis in Women","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Is confirmed Human Immunodeficiency Virus (HIV)-uninfected based on negative HIV-1\u002FHIV-2 test results\n* Has been sexually active (2 vaginal intercourse encounters with cisgender male individual(s) within the last 3 months)\n* Was assigned female sex at birth and is cisgender.\n* Weighs ≥35 kg\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has hypersensitivity or other contraindication to any component of the study interventions\n* Has evidence of acute or chronic hepatitis B infection\n* Has a history of malignancy within 5 years of screening except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer\n* Has taken cabotegravir, lenacapavir, or any other long-acting HIV prevention product at any time\n* Is receiving or is anticipated to require any prohibited therapies from 30 days prior to Day 1 through the study duration\n* Has received an HIV vaccine at any time (ie, through past participation in an investigational clinical study) or monoclonal antibodies to HIV within 12 months before Day 1","FEMALE","16 Years","30 Years",{"count":145,"type":24},4580,[63],"Researchers are looking for new medicines to prevent HIV-1 (Human Immunodeficiency Virus Type 1) infection.\n\nThe goals of this study are to learn:\n\n* If taking MK-8527 once a month works to prevent HIV-1 infection better than a standard (usual) pre-exposure prophylaxis (PrEP) taken once a day\n* About the safety of MK-8527 and if people tolerate it",[149,150],"Human Immunodeficiency Virus (HIV)","HIV Pre-Exposure Prophylaxis","2026-06-26",{"date":125,"type":42},{"date":154,"type":42},"2025-11-10",{"date":156,"type":24},"2027-10-18",{"name":158,"class":78},"Merck Sharp & Dohme LLC",30,{"id":161,"slug":162,"hasResults":12,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":166,"eligibilityCriteria":167,"healthyVolunteers":12,"sex":19,"minAge":87,"maxAge":4,"enrollmentInfo":168,"targetDuration":4,"studyType":25,"phases":170,"briefSummary":171,"conditions":172,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":174,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":180},"100507964","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-inavolisib-in-combination-with-phesgo-versus-placebo-in-combination-with-phesgo-in-participants-with-pik3ca-mutated-her2-positive-locally-advanced-or-metastatic-breast-cancer-100507964","NCT05894239","A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer","A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo As Maintenance Therapy After First Line Induction Therapy in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer","INAVO122","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1\n* Histologically or cytologically confirmed and documented adenocarcinoma of the breast with metastatic or locally advanced disease not amenable to curative resection\n* Confirmation of HER2 biomarker eligibility based on valid results from central testing of tumor tissue documenting HER2-positivity\n* Confirmation of PIK3CA-mutation biomarker eligibility based on valid results from central testing of tumor tissue documenting PIK3CA-mutated tumor status\n* Disease-free interval from completion of adjuvant or neoadjuvant systemic non-hormonal treatment to recurrence of \\>= 6 months\n* LVEF (left ventricular ejection fraction) of at least 50% measured by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA)\n* Adequate hematologic and organ function prior to initiation of study treatment\n\nExclusion Criteria:\n\n* Prior treatment in the locally advanced or metastatic setting with any PI3K, AKT, or mTOR inhibitor or any agent whose mechanism of action is to inhibit the PI3K-AKT-mTOR pathway\n* Any prior systemic non-hormonal anti-cancer therapy for locally advanced or metastatic HER2-positive breast cancer prior to initiation of induction therapy\n* History or active inflammatory bowel disease\n* Disease progression within 6 months of receiving any HER2-targeted therapy\n* Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes\n* Participants with active HBV infection\n* Clinically significant and active liver disease, including severe liver impairment, viral or other hepatitis, current alcohol abuse, or cirrhosis\n* Symptomatic active lung disease, including pneumonitis or interstitial lung disease\n* Any history of leptomeningeal disease or carcinomatous meningitis\n* Serious infection requiring IV antibiotics within 7 days prior to Day 1 of Cycle 1\n* Any concurrent ocular or intraocular condition that, in the opinion of the investigator, would require medical or surgical intervention during the study period to prevent or treat vision loss that might result from that condition\n* Active inflammatory or infectious conditions in either eye or history of idiopathic or autoimmune-associated uveitis in either eye",{"count":169,"type":24},230,[63],"This study will evaluate the efficacy and safety of inavolisib in combination with Phesgo (pertuzumab, trastuzumab, and rHuPH20 injection for subcutaneous use) compared with placebo in combination with Phesgo, as maintenance therapy, after induction therapy in participants with previously untreated HER2-positive advanced breast cancer (ABC).",[173],"Metastatic Breast Cancer",{"date":125,"type":42},{"date":176,"type":42},"2023-09-08",{"date":178,"type":24},"2032-12-28",{"name":77,"class":78},192,{"id":182,"slug":183,"hasResults":12,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":4,"eligibilityCriteria":187,"healthyVolunteers":12,"sex":19,"minAge":4,"maxAge":4,"enrollmentInfo":188,"targetDuration":4,"studyType":25,"phases":190,"briefSummary":191,"conditions":192,"keywords":195,"overallStatus":203,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":50},"100642967","kulindana-community-friendly-delivery-and-monitoring-of-tpt-to-improve-uptake-and-reduce-tb-transmission-100642967","NCT07628140","Kulindana: Community-friendly Delivery and Monitoring of TPT to Improve Uptake and Reduce TB Transmission","Kulindana: Expanding Access and Impact of Tuberculosis Preventative Therapy: Community-friendly Delivery and Monitoring of TPT to Improve Uptake and Reduce TB Transmission","Inclusion Criteria:\n\n* Household contacts (HHC) are eligible for enrolment if the participant shares a residential dwelling with an index TB patient and can provide informed consent (or parental consent, with assent if appropriate).\n* People living with HIV (PWH) are eligible for enrolment if the participant is an adult aged 15 and over, is eligible for TPT according to Kenyan National Guidelines, and can provide informed consent.\n\nExclusion Criteria:\n\n* HHC will be excluded if the participant plans on permanently relocating from the area within the next three months, is not willing to receive TPT screening and initiation at home, or is enrolled in any other investigational\u002Finterventional HIV or TB study.\n* PWH will be excluded if the participant plans on permanently relocating from the area within the next three months, has contraindications for TPT according to the Kenyan National Guidelines, or is enrolled in any other investigational\u002Finterventional HIV or TB study.",{"count":189,"type":24},1500,[27],"The goal of this clinical trial is to learn if differentiated service delivery (DSD) of TB preventive therapy (TPT) improves uptake and completion of TPT in two populations: household contacts (HHC) of index TB patients and people living with HIV (PWH). The main questions it aims to answer are:\n\n* Is community-based and multi-month dispensing of short-course TPT with minimal clinic and laboratory monitoring associated with higher rates of initiation and completion of TPT, compared to standard of care, in both HHC and PWH?\n* Does community-based and DSD TPT reduce household and community TB transmission?\n\nResearchers will compare DSD TPT delivery to standard of care (SoC) to see if DSD TPT delivery has an effect on TPT uptake and completion.\n\nParticipants will:\n\n* Be assessed for TPT eligibility through either DSD TPT service delivery of SoC including differentiated TB screening procedures.\n* If eligible, receive DSD TPT service delivery or SoC TPT service delivery.\n* Over 12 weeks receive either DSD or SoC TPT adherence assessment and follow-up.\n* Have TPT completion assessed at 12 weeks following enrolment.\n* A subset of participants will be assess for TB incidence at 9 months following enrolment.",[193,194],"Tuberculosis Prevention","HIV",[196,197,198,199,194,200,201,202],"tuberculosis","household contact","TB preventive therapy","3HP","contact investigation","multi-month dispensing","differentiated service delivery","NOT_YET_RECRUITING","2026-06-25",{"date":93,"type":42},{"date":207,"type":24},"2026-07",{"date":209,"type":24},"2031-07",{"name":211,"class":49},"University of Washington",{"id":213,"slug":214,"hasResults":12,"nctId":215,"briefTitle":216,"officialTitle":217,"acronym":4,"eligibilityCriteria":218,"healthyVolunteers":18,"sex":19,"minAge":142,"maxAge":4,"enrollmentInfo":219,"targetDuration":4,"studyType":25,"phases":221,"briefSummary":222,"conditions":223,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":224,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":230},"100596349","phase-3-a-clinical-study-of-mk-8527-to-prevent-human-immunodeficiency-virus-type-1-hiv-1-mk-8527-011-100596349","NCT07044297","A Clinical Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-011)","A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy and Safety of MK-8527 Oral Once-Monthly as HIV-1 Preexposure Prophylaxis","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Is confirmed HIV-uninfected based on negative HIV-1\u002FHIV-2 test results\n* Is a cisgender man, transgender woman (assigned male sex at birth), transgender man (assigned female sex at birth), or gender nonbinary person\n* Has had condomless receptive anal sex in the 12 months prior to screening (not including sex occurring in a mutually monogamous relationship) and has at least 1 of the following: receptive anal sex with 2 or more partners in the 3 months prior to screening (regardless of condom use), rectal or urethral gonorrhea or chlamydia or incident syphilis in the 6 months prior to screening, or any self-reported stimulant drug use with sex in the 3 months prior to screening\n* Weighs ≥35 kg\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has hypersensitivity or other contraindication to any component of the study interventions\n* Has evidence of acute or chronic hepatitis B infection\n* Has a history of malignancy within 5 years of screening except for adequately treated basal cell or squamous cell skin cancer, or in situ anal or cervical cancers\n* Has taken cabotegravir, lenacapavir, or any other long-acting HIV prevention product at any time\n* Is receiving or is anticipated to require any prohibited therapies from 30 days prior to Day 1 through the study duration\n* Has received an HIV vaccine at any time (ie, through past participation in an investigational clinical study) or monoclonal antibodies to HIV within 12 months before Day 1\n* Is expecting to donate eggs at any time during the study",{"count":220,"type":24},4390,[63],"Researchers are looking for new medicines to prevent HIV-1 (Human Immunodeficiency Virus Type 1) infection.\n\nThe goals of this study are to learn:\n\n* If taking MK-8527 once a month works to prevent HIV-1 infection as well as or better than a standard (usual) pre-exposure prophylaxis (PrEP) taken once a day\n* About the safety of MK-8527 and if people tolerate it",[149,150],{"date":125,"type":42},{"date":226,"type":42},"2025-07-31",{"date":228,"type":24},"2027-07-22",{"name":158,"class":78},81,{"id":232,"slug":233,"hasResults":12,"nctId":234,"briefTitle":235,"officialTitle":236,"acronym":4,"eligibilityCriteria":237,"healthyVolunteers":12,"sex":19,"minAge":238,"maxAge":239,"enrollmentInfo":240,"targetDuration":4,"studyType":25,"phases":242,"briefSummary":244,"conditions":245,"keywords":247,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":254,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":50},"100635952","phase-2-safety-and-efficacy-of-imatinib-in-combination-with-artemether-lumefantrine-for-uncomplicated-malaria-100635952","NCT07559370","Safety and Efficacy of Imatinib in Combination With Artemether-Lumefantrine for Uncomplicated Malaria","Evaluating the Safety and Efficacy of Imatinib in Combination With Artemether and Lumefantrine for Treatment of Uncomplicated Malaria","Inclusion Criteria:\n\nFor Part 1 and 2 of the study design, all individuals must meet all the inclusion criteria below:\n\n* Patients diagnosed with symptomatic mild to moderate P. falciparum malaria with a parasite density of \\>= 5000 parasites\u002Fμl\n* Adult male, age 18-55 years old or adult female, age 18-55 years that are post-menopausal, or test negative on a pregnancy test and will be on active birth control through to the end of the follow up period.\n* Provision of informed consent and agrees to hospital admission for 48-72hrs\n* Good health condition other than malaria\n* The patient has not taken anti-malarial drugs in the past 4 weeks\n\nFor Part 3 of the trial, all individuals must meet all the inclusion criteria below:\n\n* Patients diagnosed with symptomatic mild to moderate P. falciparum malaria and a parasite density of \\>= 5000 parasites\u002Fμl\n* Age 12 months to below 18 years\n* Presented by parent or legally accepted representative (LAR) who has consented to the participation of the child in the trial and agrees to hospital admission for 48-72hrs.\n* Hb levels \\> 5mg\u002FdL\n* Child has not taken anti-malarial drugs in the past 6 weeks.\n\nExclusion Criteria:\n\n* Prospective study participant, LAR and\u002For impartial witness (where applicable) declines to provide informed consent.\n* Symptoms and signs of severe or complicated malaria including:\n\n  * significant confusion or impaired consciousness (including unarousable coma)\n  * multiple convulsions (more than two episodes within 24 hours),\n  * respiratory distress\n  * circulatory collapse (systolic blood pressure \\\u003C80mm Hg with evidence of impaired perfusion)\n  * clinical jaundice plus evidence of other vital organ dysfunction\n  * simultaneous infection of unrelated origin\n* Parasite density \\> 200,000 parasites \u002Fμl\n* In the case of female participants: currently pregnant or lactating\n* Other neurological or psychiatric symptoms or disorders\n* Abnormal bleeding\n* Resting heart rate lower than 55 or higher than 100 bpm\n* History of cardiac disease\n* Signs, symptoms and laboratory results of impairment of vital organs such as liver, lungs, kidney and cardiovascular system\n* Abnormal blood chemistry:\n\n  * hemoglobin \\\u003C 9.0 g\u002FdL in adults or \\\u003C 5.0 g\u002FdL in children 12 months-18 years\n  * WBC not in the range of 4800-10,000\u002Fmm3\n  * RBC if \\\u003C 4.0x106\u002F mm3\n  * Platelet \\\u003C 1.3x105\u002F mm3\n  * ALAT not in the normal range (4 to 36 U \u002F l)\n  * ASAT not in the normal range (8 to 33 U \u002F l)\n  * Total bilirubin 0.1 to 1.2 mg \u002F 100 ml\n  * Serum protein if \\\u003C 5.5 g\u002FdL\n* Symptoms and signs of infection such as pneumonia, dengue fever, and other viral or bacterial infection.\n* Patients with symptoms of gastrointestinal infections or any sign of malabsorption that may interfere with drug absorption.\n* Concomitant infection by plasmodium species other than P. falciparum\n* Inability to attend\u002Fmeet study staff on follow up visits\n* Concomitant use of medicines, including:\n\n  * medicines used to treat high cholesterol (such as atorvastatin, lovastatin, simvastatin);\n  * medicines used to treat hypertension and heart problems (such as diltiazem, nifedipine, nitrendipine, verapamil, felodipine, amlodipine);\n  * medicine used to treat HIV (antiretroviral medicines) including protease inhibitors (such as amprenavir, atazanavir, indinavir, nelfinavir, ritonavir), non-nucleoside reverse transcriptase inhibitors (such as efavirenz, nevirapine);\n  * medicines used to treat microbial infections (such as telithromycin, rifampicin, dapsone);\n  * medicines used to help you fall asleep: benzodiazepines (such as midazolam, triazolam, diazepam, alprazolam), zaleplon, zolpidem;\n  * medicines used to prevent\u002Ftreat epileptic seizures including barbiturates (such as phenobarbital), carbamazepine or phenytoin;\n  * medicines used after organ transplantation and in autoimmune diseases (such as cyclosporin, tacrolimus);\n  * nefazodone (used to treat depression);\n  * aprepitant (used to treat nausea);","1 Year","55 Years",{"count":241,"type":24},1116,[243],"PHASE2","This study is investigating an innovative approach to treating uncomplicated malaria by adding a drug called Imatinib to the current standard of care, Artemether + Lumefantrine (AL). The researchers hope this combination, known as ALIM, will clear infections faster and stop the spread of drug-resistant parasites that are becoming a major threat in Africa",[246],"Malaria (Plasmodium Falciparum)",[248,249,250,251,252],"Uncomplicated malaria","Artemether-lumefantrine (AL) combination therapy","Imatinib mesylate","Drug-resistant malaria","Parasite egress blockade","2026-06-24",{"date":125,"type":42},{"date":256,"type":42},"2026-01-20",{"date":258,"type":24},"2027-06-30",{"name":260,"class":49},"Victoria Biomedical Research Institute",{"id":262,"slug":263,"hasResults":12,"nctId":264,"briefTitle":265,"officialTitle":266,"acronym":267,"eligibilityCriteria":268,"healthyVolunteers":12,"sex":19,"minAge":87,"maxAge":4,"enrollmentInfo":269,"targetDuration":4,"studyType":25,"phases":271,"briefSummary":272,"conditions":273,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":278,"completionDateStruct":280,"leadSponsor":282,"locationsCount":285},"100530851","phase-2-trial-of-novel-regimens-for-the-treatment-of-pulmonary-tuberculosis-100530851","NCT06192160","Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis","A Phase 2 Randomized, Adaptive, Dose-Ranging, Open-Label Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis","RAD-TB","Inclusion Criteria:\n\n1. Pulmonary TB (among individuals either without history of prior TB treatment or with history of TB treatment completed more than 2 years prior to study entry), identified within 7 days prior to study entry by at least one sputum specimen positive for Mtb by Xpert. Semiquantitative Mtb results of \"medium\" or \"high\" from Xpert MTB\u002FRIF Ultra are required.\n2. Pulmonary TB with documented INH susceptibility (by Line Probe Assay (LPA) or Xpert MTB\u002FXDR or other validated molecular test) and with documented RIF susceptibility (by LPA or Xpert MTB\u002FRIF or Xpert MTB\u002FRIF Ultra or other validated molecular test) within 7 days prior to study entry.\n3. Documentation of HIV-1 infection status, as below:\n\n   Presence or absence of HIV-1 infection, as documented by:\n   * Any licensed rapid HIV test or HIV-1 enzyme or chemiluminescence immunoassay (E\u002FCIA) test kit, any time prior to study entry. AND for a positive result confirmation by one of the following:\n   * A second antibody test from different manufacturers or based on different principles and epitopes (combination antigen-antibody-based rapid tests may be used), or\n   * HIV-1 antigen, or\n   * Plasma HIV-1 RNA viral load, or\n   * A licensed Western blot\n4. For individuals with HIV: CD4+ cell count ≥100 cells\u002Fmm3 based on testing performed within 30 days prior to study entry.\n5. For individuals with HIV: Currently being treated with dolutegravir-based antiretroviral therapy (ART), or plan to initiate dolutegravir-based ART at or before study week 8.\n6. Individuals age ≥18 years.\n7. The following laboratory values obtained within 7 days prior to study entry at any network-approved non-U.S. laboratory that operates in accordance with Good Clinical Laboratory Practices (GCLP) and participates in appropriate external quality assurance programs:\n\n   * Serum or plasma alanine aminotransferase (ALT) ≤3 times the upper limit of normal (ULN)\n   * Serum or plasma total bilirubin ≤2 times ULN\n   * Serum or plasma creatinine ≤2 times ULN\n   * Serum or plasma potassium ≥3.5 mEq\u002FL\n   * Serum or plasma magnesium ≥1.0 mEq\u002FL (≥0.500 mmol\u002FL)\n   * Absolute neutrophil count (ANC) ≥1500\u002Fmm\\^3\n   * Hemoglobin ≥9.0 g\u002FdL\n   * Platelet count ≥100,000\u002Fmm\\^3\n   * Negative for, hepatitis B surface antigen (HBsAg)\n   * Negative for hepatitis C virus (HCV) antibody (or if HCV antibody positive, must have a negative HCV PCR)\n8. For female study candidates who are of reproductive potential, negative pregnancy test (urine HCG or serum β-HCG) within 3 days (72 hours) prior to entry by any network-approved non-U.S. laboratory or clinic that operates in accordance with GCLP and participates in appropriate external quality assurance programs.\n\n   Females who are of reproductive potential and who participate in sexual activity that could lead to pregnancy must agree to use at least two of the following forms of birth control while receiving TB study medications and for 12 months after stopping study medications:\n   * Male or female condoms\n   * Diaphragm or cervical cap (with spermicide, if available)\n   * Intrauterine device (IUD) or intrauterine system (IUS)\n   * Hormone-based birth control (e.g., oral contraceptives, Depo-Provera, NuvaRing, implants)\n\n   Female study candidates who are of reproductive potential, but who abstain from sexual activity that could lead to pregnancy require no additional contraception.\n\n   Female study candidates who are not of reproductive potential are eligible without requiring the use of contraceptives. Self-reported history is acceptable documentation of menopause (i.e., at least 1 year amenorrheic), hysterectomy, bilateral oophorectomy, or bilateral tubal ligation; these candidates are all considered not of reproductive potential.\n9. For male study candidates who engage in sexual activity that may lead to pregnancy in their partner must agree to either remain abstinent or use male contraceptives. They are also strongly advised to inform their non-pregnant sexual partners of reproductive potential to use effective contraceptives while the individual is on study and for 90 days after experimental treatment discontinuation.\n\n   For male study candidates who have undergone successful vasectomy with documented azoospermia or have documented azoospermia for any other reason, are eligible without requiring the use of contraceptives.\n10. For male study candidates with pregnant partners, willingness to use condoms during vaginal intercourse while on study and for 90 days after experimental treatment discontinuation.\n11. For male study candidates, willingness to refrain from sperm donation while on study and for 90 days after experimental treatment discontinuation.\n12. Documentation of Karnofsky performance score ≥60 obtained within 14 days prior to study entry.\n13. Chest x-ray obtained within 14 days prior to study entry.\n14. A verifiable address or residence readily accessible for visiting, and willingness to inform the study team of any change of address during study treatment and follow-up period.\n15. Ability and willingness of individual to provide informed consent.\n\nExclusion Criteria:\n\n1. More than cumulative 7 days of treatment directed against active TB for the current TB episode in the 60 days preceding study entry.\n2. Current extrapulmonary TB, in the opinion of the investigator.\n3. QTcF interval \\>450 ms within 7 days prior to study entry.\n4. History of or ongoing heart failure.\n5. Personal or family history of congenital QT prolongation.\n6. History of known, untreated, ongoing hypothyroidism.\n7. History of or ongoing bradyarrhythmia.\n8. History of torsades de pointes.\n9. Current Grade 2 or higher peripheral neuropathy.\n10. Other medical conditions (e.g., diabetes, liver or kidney disease, blood disorders, chronic diarrhea), in the opinion of the site investigator, in which the current clinical condition of the participant is likely to prejudice the response to, or assessment of, treatment.\n11. Pregnant or breastfeeding or planning to become pregnant within the next 12 months.\n12. Weight \\\u003C35 kg.\n13. Unable to take oral medications.\n14. Taking any of prohibited medications.\n15. Known allergy\u002Fsensitivity or any hypersensitivity to components of investigational agents or their formulation.\n16. Active drug or alcohol use or dependence; or mental illness (e.g., major depression) that, in the opinion of the site investigator, would interfere with adherence to study requirements.\n17. Taking an investigational drug or vaccine within 30 or more days prior to study entry.",{"count":270,"type":24},315,[243],"A5409\u002FRAD-TB is an adaptive Phase 2 randomized, controlled, open-label, dose-ranging, platform protocol to evaluate the safety and efficacy of multidrug regimens for the treatment of adults with drug-susceptible pulmonary tuberculosis (TB).\n\nA5409 hypothesizes that novel regimens for the treatment of pulmonary tuberculosis will result in superior early efficacy, as determined by longitudinal mycobacteria growth indicator tube (MGIT) liquid culture time to positivity (TTP) measurements over the first 6 weeks of treatment, and will have acceptable safety and tolerability over 8 weeks of treatment relative to standard of care \\[(SOC) isoniazid\u002Frifampicin\u002Fpyrazinamide\u002Fethambutol (HRZE)\\].\n\nThe study will run for 52 weeks, inclusive of 26 weeks of TB treatment comprised of 8 weeks of study treatment (experimental or SOC, based on treatment arm assignment) followed by 18 weeks of SOC continuation phase treatment with 45 participants in each experimental treatment arm and at least 90 participants in the SOC arm.",[274],"Pulmonary Tuberculosis","2026-06-22",{"date":277,"type":42},"2026-06-23",{"date":279,"type":42},"2025-03-11",{"date":281,"type":24},"2027-08-11",{"name":283,"class":284},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",29,{"id":287,"slug":288,"hasResults":12,"nctId":289,"briefTitle":290,"officialTitle":291,"acronym":292,"eligibilityCriteria":293,"healthyVolunteers":12,"sex":19,"minAge":294,"maxAge":295,"enrollmentInfo":296,"targetDuration":4,"studyType":25,"phases":297,"briefSummary":298,"conditions":299,"keywords":301,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":316,"startDateStruct":317,"completionDateStruct":319,"leadSponsor":321,"locationsCount":323},"100549825","phase-3-a-study-to-investigate-the-efficacy-and-safety-of-crizanlizumab-5-mgkg-compared-with-placebo-in-adolescent-and-adult-sickle-cell-disease-patients-who-experience-frequent-vaso-occlusive-crises-sparkle-100549825","NCT06439082","A Study to Investigate the Efficacy and Safety of Crizanlizumab (5 mg\u002Fkg) Compared With Placebo in Adolescent and Adult Sickle Cell Disease Patients Who Experience Frequent Vaso-Occlusive Crises (SPARKLE)","A Phase III, Multicenter, Randomized, Placebo Controlled, Double-blind Study to Assess Efficacy and Safety of Crizanlizumab (5 mg\u002Fkg) Versus Placebo, With or Without Hydroxyurea\u002FHydroxycarbamide Therapy, in Adolescent and Adult Sickle Cell Disease Patients With Frequent Vaso-Occlusive Crises","SPARKLE","Key Inclusion Criteria:\n\n1. Participants must be aged 12 years and older on the day of signing informed consent. Adolescents include participants aged 12 to \\\u003C18 years old and adults include participants aged 18 years and older.\n2. Confirmed diagnosis of SCD by Hb electrophoresis or high-performance liquid chromatography (HPLC) (performed locally or by central laboratory if not available locally). All SCD genotypes are eligible.\n3. Experienced 4 to 12 VOCs (refer to Section 8.3.1 for study definition of VOC) that are HCP-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) within the 12 months prior to the screening visit. Baseline VOCs are determined by medical history and are required to be documented at source.\n4. If the participant is on HU\u002FHC, they must be taking it for at least 6 months and at stable dose for at least 3 months prior to the Screening visit and plan to continue taking it at the same dose and schedule until at least the participant has reached 52 weeks of the planned study treatment. Participants who have initiated HU\u002FHC 6-12 months prior to the screening visit must have evidence of insufficient control of acute pain despite initiation. These participants must have a cumulative of 4-12 VOCs in the 12 months prior to the screening period, with at least 2 during the last 6 months while on HU\u002FHC. If receiving erythropoietin stimulating agent, the participant must have been receiving the drug for at least 6 months prior to screening visit and plan to continue taking the drug at the same dose and schedule until the participant has reached 52 weeks of the planned study treatment.\n\nParticipants who have not been receiving HU\u002FHC, and\u002For erythropoietin stimulating agent must not have received it for at least 6 months prior to screening visit.\n\nKey Exclusion Criteria:\n\n1. Fewer than 4 or more than 12 VOCs that are HCP-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) within the 12 months prior to screening visit as determined by medical history and documented at source.\n2. History of stem cell transplant and\u002For gene therapy.\n3. Received blood products within 30 days prior to Week 1 Day 1 dosing.\n4. Any documented history of a clinical stroke or intracranial hemorrhage, or an uninvestigated neurologic finding within the past 12 months before screening visit. Silent infarct only present on imaging is not excluded.\n5. Participating in a chronic transfusion program (pre-planned series of transfusions for prophylactic purposes) and\u002For planning to undergo an exchange transfusion during the duration of the study; episodic transfusion in response to worsened anemia or VOC is permitted.\n6. Contraindication or hypersensitivity to any drug or metabolites from similar class as study drug or to any excipients of the study drug formulation. History of severe hypersensitivity reaction to other monoclonal antibodies, which in the opinion of the investigator may pose an increased risk of serious infusion reaction.","12 Years","100 Years",{"count":270,"type":24},[63],"A phase III, multi-center, randomized, placebo-controlled, double-blind study to assess efficacy and safety of crizanlizumab (5 mg\u002Fkg) versus placebo, with or without hydroxyurea\u002Fhydroxycarbamide therapy, in adolescent and adult Sickle Cell Disease patients with frequent vaso-occlusive crises.",[300],"Sickle Cell Disease",[300,302,303,304,305,306,307,308,309,310,311,312,313,314],"SCD","SEG101","Crizanlizumab","Hydroxyurea\u002F Hydroxycarbamide Therapy","Vaso-Occlusive Crises","Sickle Cell Anemia","blood disorders","hemoglobin","red blood cells","sickle-like shape","mutation in hemoglobin gene","sickle-cell trait","sickle-cell crisis","2026-06-18",{"date":275,"type":42},{"date":318,"type":42},"2024-10-24",{"date":320,"type":24},"2030-04-19",{"name":322,"class":78},"Novartis Pharmaceuticals",32,{"id":325,"slug":326,"hasResults":12,"nctId":327,"briefTitle":328,"officialTitle":329,"acronym":330,"eligibilityCriteria":331,"healthyVolunteers":18,"sex":19,"minAge":332,"maxAge":4,"enrollmentInfo":333,"targetDuration":4,"studyType":25,"phases":335,"briefSummary":336,"conditions":337,"keywords":339,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":343,"startDateStruct":344,"completionDateStruct":346,"leadSponsor":348,"locationsCount":50},"100599859","hiv-testing-counselor-led-care-to-catalyze-integration-of-prep-delivery-in-family-planning-clinics-100599859","NCT07089966","HIV Testing Counselor-led Care to Catalyze Integration of PrEP Delivery in Family Planning Clinics","HIV Testing Counselor-led Care to Catalyze Integration of PrEP Delivery in Family Planning Clinics: The HIV Testing Services PrEP Integration (HTS PrEP) Project","HTS PrEP","Inclusion Criteria:\n\n* ≥15 years of age\n* Accessing health services at participating public health facilities.\n* Not known to be living with HIV prior to the visit when their clinical data is first abstracted","15 Years",{"count":334,"type":24},30000,[27],"This is a cluster randomized, stepped wedge implementation study to introduce HIV testing services (HTS) counselor-led PrEP care in public health clinics in Kenya.",[149,338],"HIV Pre-exposure Prophylaxis",[340,341],"PrEP","HIV Prevention","2026-06-16",{"date":315,"type":42},{"date":345,"type":42},"2025-12-01",{"date":347,"type":24},"2029-06-30",{"name":211,"class":49},{"id":350,"slug":351,"hasResults":12,"nctId":352,"briefTitle":353,"officialTitle":354,"acronym":355,"eligibilityCriteria":356,"healthyVolunteers":18,"sex":19,"minAge":20,"maxAge":357,"enrollmentInfo":358,"targetDuration":4,"studyType":25,"phases":360,"briefSummary":361,"conditions":362,"keywords":365,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":370,"startDateStruct":371,"completionDateStruct":373,"leadSponsor":375,"locationsCount":133},"100580855","a-trial-testing-a-two-way-sms-platform-to-recognize-and-prevent-wasting-among-hiv-infected-and-hiv-exposed-uninfected-children-in-kenya-100580855","NCT06842732","A Trial Testing a Two-way SMS Platform to Recognize and Prevent Wasting Among HIV-infected and HIV-exposed Uninfected Children in Kenya","A Mixed Methods Randomized Controlled Trial Testing a Two-way SMS Platform to Recognize and Prevent Wasting Among HIV-infected and HIV-exposed Uninfected Children in Kenya","MAMMS IYCF R33","Inclusion Criteria (HIV-exposed caregiver-child pairs):\n\n* Children aged 6 to 24 months all-inclusive with a MUAC ≥ 12.5cm at the date of recruitment\n* Children living with HIV or HIV-exposed uninfected children seen as outpatients in early infant detection (EID) or HIV-care clinics at the participating hospitals\n* The child's caregiver is willing and able to provide informed consent\n* The child's caregiver can read or write or has someone to help them read or write\n* The child's caregiver is planning to remain in the catchment area with their child for \\> 6 months and willing to return to the health facility for 6-month follow up visits\n* The child's caregiver has access to a Safaricom phone line and provides a mobile phone number\n\nInclusion Criteria (healthcare workers):\n\n\\- Healthcare workers working in Homa Bay and Migori County Referral Hospitals, who have contact with pediatric inpatients\n\nExclusion Criteria:\n\n* Children with moderate or severe wasting (MUAC \\\u003C12.5cm, weight-for-height z-score \\\u003C-2, or nutritional edema) at the time of eligibility screening\n* Children with a congenital condition that limit feeding or syndromes that prevents age-appropriate feeding\n* Child is enrolled in another study that the PI judges to compromise the aims of this study\n* Child's caregiver does not pass the second training after being unable to satisfactorily complete the first MUAC training.\n* Child's caregiver is under the age of 18 years.","24 Months",{"count":359,"type":24},776,[27],"The goal of this study is to test if a two-way text-message (SMS) maternally administered malnutrition monitoring system (MAMMS) that delivers infant and young child feeding (IYCF) education and supports caregivers in monitoring their child's nutritional status at home can improve nutritional outcomes for HIV-exposed children.\n\nThe aims include 1) to determine whether the MAMMS IYCF intervention lowers the incidence of malnutrition, leads to a shorter time to recover for those that become malnourished and results in a lower incidence of hospitalizations, severe malnutrition and death, 2) to determine the cost and cost-effectiveness of the MAMMS IYCF intervention, and 3) to determine the effect of the MAMMS IYCF intervention on the behavior and attitudes of participants through change in age-appropriate feeding, IYCF knowledge, trust in the healthcare system, and intention to seek care if the child becomes wasted.\n\nThe study team will enroll 776 caregiver-child pairs aged between 6 and 24 months in Migori and Homa Bay County, Kenya. Each caregiver-child pair will be randomly assigned to either the MAMMS IYCF intervention or standard of care (SOC) and followed for 180 days (about 6 months).\n\nCaregivers assigned to the intervention arm will be asked to respond to weekly messages with the color of the MUAC tape after measuring their child's arm after being trained on how to use the MUAC measuring tape. Weekly messages will include IYCF education and other age-appropriate child health related information. Caregivers in the SOC arm will receive clinic appointment and study visit reminders only. Caregivers in the intervention arm and the SOC arm will be asked to attend the study clinic for follow-up visits at Day 90 and Day 180. At enrollment and follow-up visits, the study team will administer a survey including a child's medical history, a standardized child clinical examination, and anthropometry.",[363,364],"Malnutrition in Children","Children Exposed to HIV",[366,367,368,369],"maternally administered malnutrition monitoring system (MAMMS)","infant and young child feeding practices","wasting","two-way SMS system",{"date":315,"type":42},{"date":372,"type":42},"2025-06-05",{"date":374,"type":24},"2027-07-15",{"name":211,"class":49},{"id":377,"slug":378,"hasResults":12,"nctId":379,"briefTitle":380,"officialTitle":381,"acronym":382,"eligibilityCriteria":383,"healthyVolunteers":12,"sex":19,"minAge":294,"maxAge":4,"enrollmentInfo":384,"targetDuration":4,"studyType":25,"phases":386,"briefSummary":387,"conditions":388,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":389,"startDateStruct":391,"completionDateStruct":393,"leadSponsor":395,"locationsCount":397},"100563138","phase-3-a-study-to-evaluate-how-well-etavopivat-works-in-people-with-sickle-cell-disease-100563138","NCT06612268","A Study to Evaluate How Well Etavopivat Works in People With Sickle Cell Disease","A Global Phase 3, Randomised, Double-blind and Placebo-controlled Study Evaluating the Efficacy and Safety of Etavopivat in Adolescents and Adults With Sickle Cell Disease","Hibiscus 2","Inclusion Criteria:\n\n* Male or female.\n* Age 12 years or above at the time of signing the informed consent.\n* Confirmed diagnosis of sickle cell disease: Documentation of sickle cell disease (SCD) genotype (HbSS, HbSβ0-thalassemia or other sickle cell syndrome variants) based on prior history of laboratory testing or screening test results from central laboratory. Molecular genotyping is not required. SCD genotype may be determined from the results of haemoglobin (Hb) electrophoresis, high-performance liquid chromatography (HPLC) or similar testing. Note that Hb electrophoresis is performed by the central laboratory at screening.\n* Have 1-15 episodes of documented vaso occlusive crises (VOC) within the 12 months prior to screening. Documentation must exist in the participant's medical record prior to randomisation. Events based solely on participant recall without supporting documentation should not be counted towards eligibility.\n* Hb greater than or equal to (≥) 5.0 and less than or equal to (≤) 10.0 g\u002FdL (greater than or equal to (≥) 50 and less than or equal to (≤) 100 g\u002FL) at screening.\n\nExclusion Criteria:\n\n* More than 15 VOCs within the past 12 months prior to screening documented in the participant's medical record. Events based solely on participant recall without supporting documentation should not be counted towards eligibility.\n* Use of voxelotor or similar agent within 28 days prior to starting study treatment or anticipated need for this agent during the study.\n* Use of a selectin antagonist (e.g., crizanlizumab, monoclonal antibody or small molecule) within 28 days or 5 half-lives (whichever is longer) prior to starting study treatment or anticipated need for such agents during the study.\n* Receiving regularly scheduled blood (RBC) transfusion therapy (also termed chronic, prophylactic, or preventive transfusion) or greater than or equal to 6 transfusion events in the previous 12 months (i.e., an average of 1 transfusion event every 60 days).\n* Participants who have received an RBC transfusion for any reason within 60 days of the screening period or 60 days of the randomisation day are only eligible if HbA (adult haemoglobin) less than 10% by Hb electrophoresis is documented prior to starting study treatment.\n* Receiving or use of concomitant medications that are strong inducers of CYP3A4 (cytochrome p450 3a4) within 2 weeks of starting study treatment or anticipated need for such agents during the study.\n* Use of erythropoietin or other haematopoietic growth factor treatment within 28 days of starting study treatment or anticipated need for such agents during the study.\n* Receipt of prior cellular-based therapy (e.g., haematopoietic cell transplant, gene modification therapy).\n* Hepatic dysfunction characterized by:\n\n  * Alanine aminotransferase (ALT) greater than 4.0 × upper limit of normal (ULN) or\n  * Direct bilirubin greater than 3.0 × ULN.\n* Participants who are not taking or are unable to take antimalarial prophylaxis at the time of consent and during the study if they live in areas of endemic malaria where prophylaxis is recommended.\n* Severe renal dysfunction (estimated glomerular filtration rate \\[eGFR\\] at screening, calculated by the central laboratory greater than 30 mL\u002Fmin\u002F1.73 m\\^ 2) or on chronic dialysis.\n* Travelled distance on standardized 6MWT below 100m at screening.",{"count":385,"type":24},408,[63],"This study is conducted to confirm whether etavopivat works well at reducing the number of Vaso-occlusive crisis VOCs (sickle cell pain crises) caused by obstructions in blood vessels in adults and adolescents living with sickle cell disease. The study will also evaluate how well etavopivat can reduce the damage to different organs, improve your exercise tolerance and reduce fatigue in people with sickle cell disease.The participants will either get etavopivat or placebo. Which treatment the participants will get is decided by chance. Etavopivat is a new medicine and is currently being tested in other studies in addition to this one. The study will last for about 2 years.",[300],{"date":390,"type":42},"2026-06-17",{"date":392,"type":42},"2025-02-17",{"date":394,"type":24},"2029-03-12",{"name":396,"class":78},"Novo Nordisk A\u002FS",174,{"id":399,"slug":400,"hasResults":12,"nctId":401,"briefTitle":402,"officialTitle":403,"acronym":4,"eligibilityCriteria":404,"healthyVolunteers":12,"sex":19,"minAge":4,"maxAge":405,"enrollmentInfo":406,"targetDuration":4,"studyType":25,"phases":408,"briefSummary":410,"conditions":411,"keywords":413,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":415,"lastUpdatePostDateStruct":416,"startDateStruct":417,"completionDateStruct":419,"leadSponsor":421,"locationsCount":422},"100219916","phase-1-very-early-intensive-treatment-of-infants-living-with-hiv-to-achieve-hiv-remission-100219916","NCT02140255","Very Early Intensive Treatment of Infants Living With HIV to Achieve HIV Remission","Very Early Intensive Treatment of Infants Living With HIV to Achieve HIV Remission: A Phase I\u002FII Proof of Concept Study","Maternal Inclusion Criteria\n\n1. Presumed or confirmed maternal HIV infection:\n\n   * Mothers will be eligible to enroll with EITHER:\n\n     * Presumed HIV infection defined as at least one positive rapid HIV antibody-based test result from a sample collected in the peripartum period. Presumed infection must be confirmed within 10 business days of enrollment OR\n     * Confirmed HIV infection defined as positive results from two samples collected at different timepoints\n2. Willing and able to provide written informed consent for participation of herself and her infant. The mother must be of legal age or circumstance to provide independent informed consent as determined by site standard operating procedures (SOPs) and consistent with IRB\u002FEC policies and procedures. Otherwise, informed consent must be obtained from a legal guardian and the mother must provide written assent.\n3. Was not previously enrolled in this study with another infant.\n4. Did not receive ARVs during the current pregnancy.\n5. Infant is eligible per inclusion criteria.\n\nInfant Inclusion Criteria for Step 1\n\n1. Less than or equal to 48 hours of age.\n2. Greater than or equal to 37 weeks gestational age at birth (assessment of gestational age will be based on the best clinical estimate determined by date of last menstrual period, antenatal ultrasound, fundal height, or Ballard Score).\n3. Greater than or equal to 2 kilograms (kg) at birth.\n4. Able to take ARVs by mouth, nasogastric tube, or gastrostomy tube.\n5. Has no clinically significant diseases (other than HIV infection) or clinically significant findings during review of medical history or physical examination prior to entry that, in the site investigator's opinion, would interfere with study participation or interpretation.\n6. Mother is eligible per inclusion criteria.\n\nInfant Inclusion Criteria for Step 2\n\n1. Enrolled in Step 1.\n2. Confirmed in utero HIV infection.\n3. Able to take ARVs by mouth, nasogastric tube, or gastrostomy tube.\n4. Has no clinically significant diseases (other than HIV infection) or clinically significant findings during review of medical history or physical examination prior to entry that, in the site investigator's opinion, would interfere with study participation or interpretation.\n5. Mother (or legal guardian if applicable) is willing and able to provide written informed consent for child's participation in Step 2.\n\nInfant Inclusion Criteria for Step 3\n\n1. Enrolled in Step 2.\n2. Has reached Step 2 Week 96.\n3. Has the following results based on testing:\n\n   * No confirmed plasma HIV RNA ≥200 copies\u002FmL at Step 2 Week 24 and up to but excluding Step 2 Week 48.\n   * No plasma HIV RNA detected at Step 2 Week 48 and thereafter, with two possible exceptions\n\n     * (i) First possible exception: If HIV RNA is detected at or after Step 2 Week 48 with a result \\\u003C200 copies\u002FmL, testing will be repeated within three weeks (specimen collection for the confirmatory test must occur within three weeks of specimen collection for the initial test).\n     * If no HIV RNA is detected on the confirmatory test, or if HIV RNA is detected with a result \\\u003C200 copies\u002FmL, the infant will be potentially eligible for Step 3 after an additional 48 weeks of follow-up in Step 2, provided no HIV RNA is detected on any subsequent tests in Step 2.\n     * If HIV RNA is detected on the confirmatory test with a result ≥200 copies\u002FmL, the infant will not be eligible for Step 3.\n     * (ii) Second possible exception: If HIV RNA is detected after Step 2 Week 48 with a result \\\u003CLOD, the infant will be potentially eligible for Step 3 after an additional 48 weeks of follow-up in Step 2 with no RNA detected. There is no limit on the number of times HIV RNA may be detected with a result \\\u003CLOD after Week 48. However, infants with detectable RNA with a result \\\u003CLOD after Week 48 will not be considered for entry into Step 3 until after an additional 48 weeks of no RNA detected.\n     * Participants may experience either or both exceptions at different timepoints during follow-up in Step 2.\n4. If breastfed, must have permanently ceased breastfeeding, with no exposure to breast milk for at least six weeks prior to specimen collection for the testing specified in the criterion (#5) below.\n5. Has met ALL of the following additional criteria while in Step 2, based on testing between Step 2 Week 84 and Step 2 Week 192 (inclusive):\n\n   * Two consecutive negative HIV antibody tests by fourth generation ELISA at least eight weeks apart.\n   * Two consecutive HIV DNA tests with no DNA detected in at least 850,000 PBMCs assayed at least eight weeks apart.\n   * CD4 cell percentage greater than or equal to 25% and CD4 cell absolute count greater than or equal to the lower limit of normal for age (≥1000 cells\u002FmL if 2 to less than 3 years of age; ≥750 cells\u002FmL if 3 to less than 5 years of age; ≥500 cells\u002FmL if 5 years of age or older).\n   * Infant assessed by the site investigator or designee as expected to adhere to the Step 3 Schedule of Evaluations.\n   * Mother (or legal guardian if applicable) willing and able to provide written informed consent for child's participation in Step 3 and Step 4.\n6. No plasma HIV RNA detected by testing after criteria have been confirmed, with specimen collection for the assay within 14 days prior to Step 3 Entry.\n\nInfant Inclusion Criteria for Step 4\n\n1. Enrolled in Step 3.\n2. Has met at least one of the following:\n\n   * Plasma HIV RNA ≥LOD based on two assays.\n   * Plasma HIV RNA ≥1000 copies\u002FmL in the presence of fever or other sign or symptom of acute retroviral syndrome.\n   * Confirmed or suspected diagnosis of acute retroviral syndrome.\n   * Confirmed or suspected diagnosis of a new WHO Clinical Stage 3 or 4 condition.\n   * Confirmed CD4 cell percentage less than 25% and CD4 cell absolute count less than the lower limit of normal for age (\\\u003C1000 cells\u002FmL if 2 to less than 3 years of age; \\\u003C750 cells\u002FmL if 3 to less than 5 years of age; \\\u003C500 cells\u002FmL if 5 years of age or older).\n   * Otherwise assessed by the site investigator or designee, in consultation with the Clinical Management Committee (CMC), as having an indication to re-initiate treatment.","48 Hours",{"count":407,"type":24},1120,[409,243],"PHASE1","The study will explore the effects of early intensive antiretroviral therapy (ART) with or without a broadly neutralizing antibody (bNAb) on achieving HIV remission (HIV RNA below the limit of detection of the assay) among infants living with HIV.",[412],"HIV Infection",[414],"HIV Remission","2026-06-15",{"date":390,"type":42},{"date":418,"type":42},"2015-01-23",{"date":420,"type":24},"2031-12-31",{"name":283,"class":284},46,{"id":424,"slug":425,"hasResults":12,"nctId":426,"briefTitle":427,"officialTitle":428,"acronym":4,"eligibilityCriteria":429,"healthyVolunteers":12,"sex":19,"minAge":87,"maxAge":430,"enrollmentInfo":431,"targetDuration":4,"studyType":25,"phases":433,"briefSummary":434,"conditions":435,"keywords":438,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":440,"lastUpdatePostDateStruct":441,"startDateStruct":442,"completionDateStruct":444,"leadSponsor":446,"locationsCount":447},"100570302","phase-2-pramipexole-versus-escitalopram-to-treat-major-depressive-disorder-mdd-and-comorbid-mdd-with-mild-neurocognitive-disorder-mnd-in-persons-with-hiv-100570302","NCT06705478","Pramipexole Versus Escitalopram to Treat Major Depressive Disorder (MDD) and Comorbid MDD With Mild Neurocognitive Disorder (MND) in Persons With HIV","An Open-Label, Randomized Controlled Trial of Pramipexole Versus Escitalopram to Treat Major Depressive Disorder (MDD) and Comorbid MDD With Mild Neurocognitive Disorder (MND) in Persons With HIV","Inclusion Criteria:\n\n* Documented HIV-1 infection.\n* Diagnosis of MDD.\n* On current ART regimen for at least 90 days prior to study entry with no interruption in treatment greater than 7 consecutive days.\n* No plans to change ART while on study.\n* Plasma HIV-1 RNA levels of less than 200 copies\u002FmL obtained within 90 days prior to enrollment.\n* Study candidates previously treated for depression are eligible provided the study candidate's last dose of antidepressant taken is at least 4 weeks prior to study entry, with the exception of fluoxetine, which the last dose taken must have been at least 8 weeks prior to study entry.\n* Laboratory values obtained within 30 days prior to study entry that meet protocol criteria as determined by the site investigator of record.\n* Study candidates of child-bearing potential must have a negative serum or urine pregnancy test performed at screening and within 2 days prior to study entry.\n* Study candidates of child-bearing potential who are participating in sexual activity that could lead to pregnancy must agree to use at least one highly effective method for contraception.\n\nExclusion Criteria:\n\n* Active suicidality, and\u002For severe MDD, psychotic disorders, manic or hypomanic symptoms occurring in the context of bipolar disorder type I or II, or cyclothymic disorder, or another current Axis I diagnosis judged by the investigator to interfere with the trial.\n* Study candidate self-report of depressive symptoms that have persisted for over 50 percent of waking hours and for over 50 percent of days over the 24 months prior to study entry.\n* Severe, active alcohol or substance use disorder by DSM-5-TR criteria in the 6 months prior to study entry.\n* Active alcohol or substance use judged by the investigator to interfere with the trial.\n* Any acute infection within 14 days prior to study entry.\n* Acute or serious illness requiring systemic treatment and\u002For hospitalization within 90 days prior to study entry.\n* Active coronary artery disease (CAD) or myocardial infarction (MI) within 180 days prior to study entry.\n* Presence of rheumatoid arthritis, Sjogren's syndrome, systemic lupus erythematosus (SLE), dermatomyositis, ulcerative colitis, Crohn's disease, or other chronic inflammatory conditions.\n* Immune reconstitution inflammatory syndrome (IRIS) or a history of IRIS within 180 days prior to study entry.\n* Unstable or advanced liver disease.\n* Receipt of medications judged by the site investigator to significantly influence depression or neurocognitive function within 30 days prior to study entry.\n* Non-HIV-associated neurological disorder comorbidity.\n* Diagnosis of epilepsy with antiepileptic drug treatment.\n* Untreated HCV infection and HCV viremia.\n* Current CNS malignant tumor or CNS opportunistic infection (OI).\n* Current systemic malignant tumor or of a current systemic AIDS-defining OI.\n* History of completed treatment of CNS or systemic malignant tumor within the 5 years prior to study entry.\n* History of completed treatment of CNS OI within the 5 years prior to study entry.\n* Documented history of completed treatment of systemic AIDS-defining OI, as well as Mycobacterium Tuberculosis Infection, within the 180 days prior to study entry.\n* New diagnosis of syphilis or treatment for syphilis within the 180 days prior to study entry.\n* History of neurosyphilis.\n* Severe chronic obstructive pulmonary disease.\n* Congestive heart failure (CHF).\n* Use of systemic steroids daily (except testosterone).\n* Diseases that cause a known bleeding diathesis.\n* Immunostimulant therapies and trials of non-FDA-approved ARV medications within 30 days prior to study entry.\n* Immunosuppressive medications if judged by the investigator to affect study outcomes.\n* Currently pregnant, planning to become pregnant during the study period, or currently breastfeeding.\n* Known allergy\u002Fsensitivity or any hypersensitivity to the study drugs or their formulations.\n* Study candidates on prohibited medications at the time of screening will be excluded from study participation.\n\nInclusion Criteria for Participants at US Sites Who Consent to the Lumbar Puncture (LP) Procedure:\n\n* Non-focal neurological examination. Study candidates with focal findings should have expert assessment for mass effect prior to the LP.\n* Laboratory values that meet LP protocol criteria as determined by the site investigator.\n\nExclusion Criteria for Participants at US Sites who Consent to the LP Procedure:\n\n* Current use of anti-coagulants.\n* Known presence of intracerebral mass or lesion that is judged to affect the safety of an LP.\n* Known presence of an active CNS infection that could alter CNS\u002FCSF inflammatory measures.\n* Known allergy to lidocaine.\n* Individuals who are unable to safely tolerate an LP due to physical limitation or condition.\n* Body mass index (BMI) greater than 40 kg\u002Fm\\^2.","70 Years",{"count":432,"type":24},186,[243],"A phase II, randomized, open-label, two-arm clinical trial evaluating the safety and efficacy of pramipexole extended release (ER) versus escitalopram for the treatment of major depressive disorder (MDD) and comorbid MDD with mild neurocognitive disorder (MND) in persons with HIV (PWH). Participants will be assessed comprehensively and briefly at intercurrent visits to monitor for toxicity, response to therapy, and to assess for dose changes.\n\nAn optional sub-study to evaluate treatment impact on the cerebrospinal fluid (CSF) profile will be conducted in a subset of 36 participants.",[436,437,194],"Major Depressive Disorder","Mild Neurocognitive Disorder",[439],"Comorbid MND","2026-06-12",{"date":415,"type":42},{"date":443,"type":42},"2026-05-17",{"date":445,"type":24},"2026-12-02",{"name":283,"class":284},41,{"id":449,"slug":450,"hasResults":12,"nctId":451,"briefTitle":452,"officialTitle":453,"acronym":4,"eligibilityCriteria":454,"healthyVolunteers":12,"sex":19,"minAge":455,"maxAge":4,"enrollmentInfo":456,"targetDuration":4,"studyType":25,"phases":458,"briefSummary":459,"conditions":460,"keywords":462,"overallStatus":203,"whyStopped":4,"lastUpdateSubmitDate":471,"lastUpdatePostDateStruct":472,"startDateStruct":473,"completionDateStruct":475,"leadSponsor":477,"locationsCount":285},"100641915","phase-2-a-trial-of-stratified-patient-centered-treatment-regimens-for-active-tb-spectra-tb-100641915","NCT07595042","A Trial of Stratified Patient-Centered Treatment Regimens for Active TB (SPECTRA-TB)","A Phase 2C Trial of Stratified Patient-Centered Treatment Regimens for Active TB","Inclusion Criteria:\n\n* Has pulmonary tuberculosis (TB) that is likely to respond to standard TB medicines (drug-susceptible TB), based on sputum testing done within 7 days before entering the study. The test must show Mycobacterium tuberculosis is present, with no rifamycin resistance detected and no known resistance to isoniazid or fluoroquinolones.\n* Has a SPECTRA-TB risk score and risk group assigned during screening using the study-specific calculator.\n* Has a Karnofsky performance score of 50 or higher within 30 days before entering the study.\n* Has documented HIV-1 status (either with HIV or without HIV) based on acceptable testing.\n* If living with HIV, has a CD4+ cell count of at least 50 cells\u002Fmm3 within 60 days before study entry.\n* If living with HIV, is currently receiving or plans to start an efavirenz-based or dolutegravir-based antiretroviral therapy regimen by study week 8.\n* Has laboratory test results within 7 days before study entry that meet all of the following:\n\n  * alanine aminotransferase (ALT) no more than 3 times the upper limit of normal\n  * total bilirubin no more than 2.5 times the upper limit of normal\n  * creatinine no more than 2 times the upper limit of normal\n  * potassium between 3.5 and 5.5 mEq\u002FL\n  * absolute neutrophil count at least 1000\u002Fmm3\n  * hemoglobin at least 7.0 g\u002FdL\n  * platelet count at least 100,000\u002Fmm3\n* If able to become pregnant, has a negative blood or urine pregnancy test within 7 days before study entry.\n* If able to become pregnant and sexually active in a way that could lead to pregnancy, agrees not to try to become pregnant and agrees to use at least 1 reliable non-hormonal birth control method during study treatment and for 30 days after stopping study drugs. Acceptable methods include:\n\n  * condoms\n  * intrauterine device (IUD) or intrauterine system (IUS)\n  * cervical cap with spermicide\n  * diaphragm with spermicide\n* If not able to become pregnant, has a history or documentation of menopause, hysterectomy, bilateral removal of the ovaries, or bilateral tubal ligation.\n* Has a verifiable address or place of residence and is willing to tell the study team about any change of address during treatment and follow-up.\n* Is willing and able to give informed consent, or assent with permission from a parent or legal guardian if required.\n\nExclusion Criteria:\n\n* TB bacteria are known to be resistant to 1 or more of the following medicines: rifampin, isoniazid, pyrazinamide, ethambutol, or fluoroquinolones.\n* Received more than 5 days of treatment for active TB within the 24 weeks before study entry.\n* Received more than 5 days of treatment within the 30 days before study entry with certain TB medicines or related antibiotics, including isoniazid, rifampin, rifapentine, ethambutol, moxifloxacin, pyrazinamide, aminoglycosides, fluoroquinolones, linezolid, bedaquiline, pretomanid, and other specified anti-TB drugs.\n* Has suspected or confirmed TB involving the brain or central nervous system, bones, joints, heart lining (pericardium), or miliary TB.\n* Has a past history of suspected or confirmed drug-resistant TB of any type.\n* Is currently pregnant or breastfeeding.\n* Cannot take medicines by mouth.\n* Has an HIV\u002FAIDS-related opportunistic infection at study entry.\n* Has acute or chronic hepatitis B, unless the hepatitis B infection has cleared.\n* Has acute or chronic hepatitis C, unless the hepatitis C infection has cleared or has been successfully treated.\n* Has alcohol-related liver disease.\n* Has liver cirrhosis.\n* Has a history of aortic aneurysm or aortic dissection.\n* Has a known history of long QT syndrome, a first-degree relative with long QT syndrome, or a screening ECG showing QTcF greater than 470 ms that does not correct with treatment of contributing factors.\n* Is taking other medicines that can prolong the QT interval and cannot safely switch to an alternative medicine.\n* Has a known history of acute intermittent porphyria.\n* Weighs less than 30 kg.\n* Is currently using, or is expected to need within 24 weeks after enrollment, 1 or more medicines that are not allowed during the study.\n* Has a known allergy, sensitivity, or hypersensitivity to any of the study drugs or their ingredients.\n* Has active drug or alcohol use, dependence, mental illness, or another serious infection that, in the opinion of the site investigator, could make it hard to follow the study requirements.\n* Is currently taking part in another interventional clinical trial.","13 Years",{"count":457,"type":24},900,[243],"The A5414 study will evaluate whether treatment for drug-susceptible pulmonary tuberculosis (TB) can be tailored according to a participant's risk of an unfavorable outcome. Participants will be assigned to lower-risk or higher-risk groups using baseline characteristics and then randomized within each group to receive either standard TB treatment or an investigational rifapentine- and moxifloxacin-containing regimen. The study will evaluate whether shorter treatment durations may be used in lower-risk participants and whether the investigational regimen may improve outcomes in higher-risk participants. Safety and tolerability will also be evaluated.",[461],"Tuberculosis",[461,463,464,465,466,467,468,469,470],"Pulmonary tuberculosis","Drug-susceptible tuberculosis","Rifampin-susceptible tuberculosis","Rifapentine","Moxifloxacin","HIV coinfection","Treatment shortening","Risk-stratified treatment","2026-06-11",{"date":415,"type":42},{"date":474,"type":24},"2026-07-31",{"date":476,"type":24},"2029-10-22",{"name":283,"class":284},{"id":479,"slug":480,"hasResults":12,"nctId":481,"briefTitle":482,"officialTitle":483,"acronym":4,"eligibilityCriteria":484,"healthyVolunteers":12,"sex":19,"minAge":4,"maxAge":455,"enrollmentInfo":485,"targetDuration":4,"studyType":25,"phases":487,"briefSummary":488,"conditions":489,"keywords":490,"overallStatus":203,"whyStopped":4,"lastUpdateSubmitDate":471,"lastUpdatePostDateStruct":492,"startDateStruct":493,"completionDateStruct":495,"leadSponsor":497,"locationsCount":498},"100602518","phase-1-a-study-of-daily-rifapentine-combined-with-isoniazid-1hp-for-tuberculosis-prevention-in-children-less-than-13-years-of-age-with-and-without-hiv-100602518","NCT07124559","A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV","Phase I\u002FII Dose Finding, Safety and Tolerability Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV","Inclusion Criteria:\n\n1. A parent or legal guardian must be willing and able to give written permission for the child to participate in the study. If required by local policies, the child must also be willing and able to give written assent to participate. All sites must follow local policies and procedures.\n2. Age requirements at entry:\n\n   * Cohort 1: Children under 13 years old.\n   * Cohort 2: Children aged 12 weeks to under 13 years old.\n3. For Cohort 1 participants under 28 days old: The child must have been born at or after 37 weeks of pregnancy, as determined by the site investigator using parent\u002Fguardian report or medical records.\n4. Weight requirements at entry:\n\n   * Cohort 1: 3 kg to under 45 kg.\n   * Cohort 2: 6 kg to under 45 kg.\n5. HIV status:\n\n   * Cohort 1: Must be living without HIV.\n   * Cohort 2: Must be living with HIV.\n6. At risk of TB disease, defined as meeting at least one of the following:\n\n   * Having close contact with someone with infectious pulmonary TB within the past six months.\n   * A positive tuberculin skin test (TST) or, for those over two years old, a positive interferon gamma release assay (IGRA) if TST is not available.\n   * For Cohort 2 only: Living in a high TB burden area (≥ 60 TB cases per 100,000 people per year).\n7. Normal or mild (grade 1 or 2) test results for the following at screening (within 21 days before entry):\n\n   * ALT (liver enzyme)\n   * Estimated glomerular filtration rate (kidney function)\n   * Absolute neutrophil count (white blood cells)\n   * Hemoglobin (red blood cells)\n8. For Cohort 2 participants:\n\n   * Must have been on antiretroviral therapy (ART) for at least 12 weeks before entry.\n   * Must have been on a specific ART regimen (once-daily DTG and two NRTIs) for at least 14 days before entry.\n   * Must have used the same formulation of DTG (tablet or dispersible tablet) for at least three days before entry.\n   * Must agree to continue the same formulation of DTG for the study duration.\n   * Must have an HIV-1 RNA level below 200 copies\u002FmL at screening.\n9. Must intend to stay in the same area for the study duration.\n10. Must have access to at least one meal per day during the 28-day treatment period.\n\nExclusion Criteria:\n\n1. The child has active TB, confirmed by medical records, parent\u002Fguardian report, or tests during screening, indicated by:\n\n   * Currently being treated for active TB.\n   * Symptoms like poor growth, poor weight gain, weight loss, cough for at least 11 days, or fever for at least eight days.\n   * X-ray or CT scan showing TB.\n   * Positive TB test results (e.g., culture, Xpert MTB\u002FRIF Ultra, Truenat M.tb, other nucleic acid tests, urine tests).\n2. The child has been exposed to an adult with drug-resistant TB (resistant to Rifampicin or Isoniazid) within the past six months.\n3. The child has taken the following medications:\n\n   * Daily Isoniazid in the 28 days before entry.\n   * Any prohibited medications listed in the study within three days before entry.\n4. The child has any of the following conditions:\n\n   * Acute or chronic hepatitis.\n   * Allergy to Isoniazid or rifamycins.\n   * Porphyria.\n   * Severe peripheral neuropathy.\n5. The child has severe acute malnutrition (weight-for-height\u002Flength less than -3 z-scores of WHO standards). Note: Children who are stunted (height-for-age more than two standard deviations below WHO standards) are eligible.\n6. For Cohort 2: The child has an active AIDS-defining opportunistic infection.\n7. The child has started menstruation.\n8. The child has taken NVP, EFV, lopinavir\u002Fritonavir, and\u002For raltegravir within 14 days before entry.\n9. The child has received long-term immunosuppressive therapy (more than eight days) within 30 days before entry. Note: Short courses of steroids (seven days or less) may be allowed with approval.\n10. The child is a result of a multiple birth (e.g., twins, triplets).\n11. The child has any other significant medical condition that would make participation unsafe, complicate data interpretation, or interfere with study objectives, as determined by the site investigator.",{"count":486,"type":24},144,[409,243],"This study aims to find the proposed dose of Rifapentine (RPT) taken once daily with Isoniazid (INH) for 28 days to prevent tuberculosis (TB). The study will take place at multiple locations and children under 13 years old will be divided into two groups: one group will include children without HIV, and the other group will include children with HIV who are on antiretroviral treatment. Up to 144 children will participate, and participants in each group will be followed for 24 weeks.",[461],[194,461,491],"Latent Tuberculosis",{"date":440,"type":42},{"date":494,"type":24},"2026-07-15",{"date":496,"type":24},"2028-05-31",{"name":283,"class":284},11,{"id":500,"slug":501,"hasResults":12,"nctId":502,"briefTitle":503,"officialTitle":504,"acronym":505,"eligibilityCriteria":506,"healthyVolunteers":18,"sex":141,"minAge":332,"maxAge":4,"enrollmentInfo":507,"targetDuration":4,"studyType":509,"phases":4,"briefSummary":510,"conditions":511,"keywords":513,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":517,"lastUpdatePostDateStruct":518,"startDateStruct":519,"completionDateStruct":521,"leadSponsor":523,"locationsCount":101},"100508724","prisma-maternal-and-newborn-health-study-100508724","NCT05904145","PRISMA Maternal and Newborn Health Study","Pregnancy Risk, Infant Surveillance, and Measurement Alliance (PRiSMA) Maternal and Newborn Health (MNH) Study: A Multi-center, Prospective Cohort Study of Maternal, Newborn, and Infant Health","PRiSMA-MNH","A woman who meets the following inclusion criteria during screening may be enrolled:\n\n* Lives within the study catchment area;\n* Meets minimum age requirement in study site country:\n\n  * Ghana: 15 years of age;\n  * Kenya: 18 years of age or those who meet the criteria of emancipated minors;\n  * Pakistan: 15 years of age or those who meet the criteria of emancipated minors;\n  * Zambia: 15 years of age;\n  * India: 18 years of age\n* Intrauterine pregnancy \\\u003C20 weeks gestation verified via ultrasound;\n* Provides informed consent.\n\nA woman who meets the following exclusion criteria during screening may NOT be enrolled:\n\n* Nonviable (e.g. ectopic or molar) pregnancy;\n* Plans to relocate outside of the study catchment area during pregnancy and\u002For postpartum.",{"count":508,"type":24},267897,"OBSERVATIONAL","Access to quality antenatal care (ANC) and postnatal care (PNC), including maternal, newborn, and infant services, is integral to reducing adverse pregnancy-related health outcomes and promoting positive birth experiences. The World Health Organization (WHO) recommends a total of eight ANC visits for pregnant women. However, the ANC coverage rate remains considerably lower among more vulnerable populations, and the quality of care that women receive is inconsistent, often poor, and frequently fails to detect risks in a timely fashion or adequately prepare women for the birth process. While rates of facility-based delivery are on the rise worldwide, disparities persist and the quality of care across facilities remains uneven. Even less information is available on PNC, where services beyond routine immunizations may not be widely available, especially in resource-poor regions.\n\nAdditionally, limited evidence exists on innovative service delivery approaches and how to effectively scale tested maternal and newborn health (MNH) interventions. This coupled with the fragmented datasets from smaller studies limit our ability to advocate for policy change.\n\nThe Pregnancy Risk Stratification Innovation and Measurement Alliance (PRiSMA) is implementing a harmonized open cohort study that seeks to evaluate pregnancy risk factors and their associations with adverse pregnancy outcomes, including stillbirth, neonatal mortality and morbidity, and maternal mortality and severe morbidity. The goals are to develop a harmonized data set to improve understanding of pregnancy risk factors, vulnerabilities, and morbidity and mortality and to estimate the burden of these risk factors and outcomes in LMICs. Ultimately, these data will inform development of innovative strategies to optimize pregnancy outcomes for mothers and their newborns.",[512],"Pregnancy, High Risk",[514,515,516],"Antenatal Care (ANC)","Postnatal Care (PNC)","Maternal Newborn Health","2026-06-09",{"date":471,"type":42},{"date":520,"type":42},"2022-08-01",{"date":522,"type":24},"2028-12-31",{"name":524,"class":49},"George Washington University",{"id":526,"slug":527,"hasResults":12,"nctId":528,"briefTitle":529,"officialTitle":530,"acronym":531,"eligibilityCriteria":532,"healthyVolunteers":12,"sex":19,"minAge":533,"maxAge":4,"enrollmentInfo":534,"targetDuration":4,"studyType":25,"phases":536,"briefSummary":537,"conditions":538,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":540,"lastUpdatePostDateStruct":541,"startDateStruct":543,"completionDateStruct":545,"leadSponsor":547,"locationsCount":548},"100562904","phase-3-a-research-study-looking-at-long-term-treatment-with-etavopivat-in-people-with-sickle-cell-disease-or-thalassaemia-100562904","NCT06609226","A Research Study Looking at Long-term Treatment With Etavopivat in People With Sickle Cell Disease or Thalassaemia","An Open-label, Multi-centre, Rollover Study to Characterise Long-term Safety and Efficacy of Etavopivat in Adults, Adolescents and Children Who Have Sickle Cell Disease or Thalassaemia and Have Completed a Treatment Period in an Etavopivat Study","FLORAL","Inclusion Criteria:\n\n* Participant must have ongoing participation in an etavopivat parent study for treatment of sickle cell disease (SCD) or thalassaemia and have completed at least a treatment period of the parent study.\n* Participant must have derived clinical benefit from treatment with etavopivat, as determined by the investigator.\n* Any participant with dose reduction or temporary discontinuation will need to be successfully rechallenged to the full dose of etavopivat before transferring.\n* Participants on hydroxyurea (HU), crizanlizumab or l-glutamine oral powder (Endari®) treatment at the time of consent may be eligible if they have been on a stable dose in the parent study as defined at the investigator's discretion. Necessary adjustments related to weight or age are accepted. Participants with temporary dose reductions or pauses due to medical reasons may still be considered to have a stable dose, as determined by the investigator, who will assess the impact of these adjustments based on clinical context and the participant's overall health status.\n\nExclusion Criteria:\n\n* Any disorder, except for conditions associated with SCD or thalassaemia, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.\n* Participant withdrew or had permanent treatment discontinuation from an etavopivat clinical study.\n* Participants on permanent dose reduction (greater than \\[\\>\\] 28 days or more) or ongoing temporary treatment discontinuation.\n* Use of any of the following within the timeframes prior to the transfer visit as stated:\n* Use of haemoglobin S (HbS) polymerisation inhibitors within participation of the parent study or anticipated need for this agent during this study.\n* Use of an experimental selectin antagonist (e.g., monoclonal antibody or small molecule) within the parent study or anticipated need for such agents during this study.\n* Use of erythropoietin or other haematopoietic growth factor treatment for more than 4 consecutive weeks during the parent study or anticipated need of such agents for a maintenance treatment during this study.\n* Receiving or use of concomitant medications that are strong inducers of cytochrome P450 (CYP) 3A4 within 2 weeks of the transfer visit or anticipated need for such agents during the study.\n* Current participation in a study that is not a designated parent study, or planned participation in any other clinical study, for the duration of FLORAL.","2 Years",{"count":535,"type":24},480,[63],"Etavopivat is a new medicine under development for treating blood disorders like sickle cell disease and thalassaemia. Sickle cell disease and thalassaemia are inherited blood disorders that affect haemoglobin. Haemoglobin is the protein that carries oxygen through the body. This study is looking into how safe treatment with etavopivat is and how well it works over a long period of time. The study will last for up to 264 weeks, but it will end earlier if etavopivat is approved in the participant's country.",[300,539],"Thalassemia","2026-06-08",{"date":542,"type":42},"2026-06-10",{"date":544,"type":42},"2025-01-10",{"date":546,"type":24},"2030-12-30",{"name":396,"class":78},105,{"id":550,"slug":551,"hasResults":12,"nctId":552,"briefTitle":553,"officialTitle":554,"acronym":4,"eligibilityCriteria":555,"healthyVolunteers":12,"sex":19,"minAge":87,"maxAge":4,"enrollmentInfo":556,"targetDuration":4,"studyType":25,"phases":558,"briefSummary":559,"conditions":560,"keywords":562,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":566,"lastUpdatePostDateStruct":567,"startDateStruct":569,"completionDateStruct":571,"leadSponsor":573,"locationsCount":574},"100521142","phase-3-a-study-to-evaluate-efficacy-and-safety-of-giredestrant-compared-with-fulvestrant-plus-a-cdk46-inhibitor-in-participants-with-er-positive-her2-negative-advanced-breast-cancer-resistant-to-adjuvant-endocrine-therapy-pionera-breast-cancer-100521142","NCT06065748","A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4\u002F6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer)","A Phase III Randomized, Open-Label Study Evaluating Efficacy and Safety of Giredestrant Compared With Fulvestrant, Both Combined With a CDK4\u002F6 Inhibitor, in Patients With Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer With Resistance to Prior Adjuvant Endocrine Therapy","Inclusion Criteria:\n\n* Locally advanced or metastatic adenocarcinoma of the breast, not amenable to treatment with curative intent\n* Documented estrogen receptor-positive (ER+), HER2-negative (HER2-) tumor assessed locally on the most recent tumor biopsy (or an archived tumor sample if a recent tumor sample is not available for testing)\n* Confirmed ESR1 mutation status (ESR1m versus ESR1nmd) in baseline circulating tumor DNA (ctDNA) through central laboratory testing\n* Resistance to prior adjuvant endocrine therapy (ET), which is defined as having relapsed with prior standard adjuvant ET, on-treatment after \\>\u002F=12 months or off-treatment within 12 months of completion. Prior use of adjuvant CDK4\u002F6i is allowed (if relapse occurred \\>\u002F=12 months since completion).\n* No prior systemic anti-cancer therapy for advanced disease\n* Measurable disease as defined per RECIST v.1.1 or non-measurable (including bone-only) disease\n* Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1\n* For pre\u002Fperimenopausal women and for men: willing to undergo and maintain treatment with approved LHRH agonist therapy (as per local guidelines) for the duration of study treatment\n\nExclusion Criteria:\n\n* Prior systemic therapy (e.g., prior chemotherapy, immunotherapy, or biologic therapy) for locally advanced unresectable or metastatic breast cancer\n* Prior treatment with another SERD (e.g., fulvestrant, oral SERDs) or novel ER-targeting agents\n* Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term\n* Active cardiac disease or history of cardiac dysfunction\n* Clinically significant history of liver disease",{"count":557,"type":24},1050,[63],"This is a Phase III, randomized, open-label multicenter study that will evaluate the efficacy and safety of giredestrant compared with fulvestrant, both in combination with the investigator's choice of a CDK4\u002F6 inhibitor (palbociclib, ribociclib or abemaciclib), in participants with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer who have developed resistance to adjuvant endocrine therapy.",[561],"Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer",[563,564,565],"oral Selective Estrogen Receptor Degrader (SERD)","CDK4\u002F6 inhibitor (CDK4\u002F6i)","ESR1 mutation","2026-06-03",{"date":568,"type":42},"2026-06-04",{"date":570,"type":42},"2023-12-11",{"date":572,"type":24},"2029-02-12",{"name":77,"class":78},352,{"id":576,"slug":577,"hasResults":12,"nctId":578,"briefTitle":579,"officialTitle":580,"acronym":4,"eligibilityCriteria":581,"healthyVolunteers":18,"sex":141,"minAge":87,"maxAge":58,"enrollmentInfo":582,"targetDuration":4,"studyType":25,"phases":584,"briefSummary":585,"conditions":586,"keywords":588,"overallStatus":203,"whyStopped":4,"lastUpdateSubmitDate":598,"lastUpdatePostDateStruct":599,"startDateStruct":600,"completionDateStruct":601,"leadSponsor":603,"locationsCount":50},"100639390","effects-of-copper-versus-levonorgestrel-intrauterine-devices-on-mucosal-microbiota-and-barrier-function-among-young-african-women-100639390","NCT07627958","Effects of Copper Versus Levonorgestrel Intrauterine Devices on Mucosal Microbiota and Barrier Function Among Young African Women","Effects of Copper Versus Levonorgestrel Intrauterine Devices on Mucosal Microbiota and Barrier Function: a Randomized Trial Among Young African Women","Inclusion Criteria:\n\n* Willing and able to provide written informed consent for screening and trial participation\n* Desire and willingness to use either IUD or IUS for contraception for at least one year\n* Clear understanding of study randomization and commitment to use the assigned IUD\n* Between 18 and 40 years of age (inclusive)\n* Willing and able to actively participate in the study for 12 months\n* Willing to be tested for HIV\n* Sexually active\n* HIV-negative\n* Would benefit from STI prevention\n\nExclusion Criteria:\n\n* Living with HIV or HIV screening results that are not definitively negative\n* Currently pregnant or planning to become pregnant within the next 12 months\n* Documented or known history of infertility or sterilization\n* Prior history of ectopic pregnancy\n* Use of contraceptive implant, IUD or injectable progestin in the past 3 months\n* Use of oral contraceptives in the past 30 days\n* Planning to use alternative contraception except condoms for the trial duration\n* 0-6 weeks postpartum\n* Has had a hysterectomy or sterilization\n* History of challenges using and IUD\u002FIUS, including frequent expulsion\n* Medical contraindications (Category 3 or 4 criteria as detailed in the WHO MEC1 to copper IUDs or LNG-IUS, including:\n\n  * Endometrial, ovarian, or cervical cancer\n  * Unexplained vaginal bleeding between menstrual periods or bleeding after intercourse\n  * History of pelvic tuberculosis\n  * Anatomical abnormality of the uterus incompatible with IUD insertion\n  * A recent septic abortion\n  * Untreated mucopurulent cervicitis on exam, untreated pelvic inflammatory disease (PID), or untreated known gonorrhoea or chlamydia\n* Has any condition (social or medical), which in the opinion of the investigator, would make study participation unsafe or complicate data interpretation",{"count":583,"type":24},120,[27],"The goal of this clinical trial is to definitively determine whether copper intrauterine device (IUD) or hormonal intrauterine system (IUS) results in greater vaginal microbial diversity after 1 year in women (n= approximately 120) aged 18-40 years, who desire to use a copper IUD or hormonal IUS as contraception, are HIV-negative and could benefit from STI prevention.\n\nThe main questions it aims to answer are:\n\n1. Whether women assigned to copper IUD vs hormonal IUS have differences in vaginal microbial diversity after 1 year of use\n2. Whether women randomized to Copper IUD have reduced genital mucosal barrier integrity as indicated by proteomic signatures\n3. Whether women randomized to Copper IUD have greater incidence of high-risk HPV or curable STIs (Ct, Ng, Tv)\n\nParticipants will be assigned to have either the copper IUD or the hormonal IUS inserted as contraception. After that, they will have blood and vaginal fluids collected every 3 months for one year to look at the bacteria in their vagina, test for sexually transmitted infections, and examine markers of vaginal health.\n\nAfter enrolment, each participant will be followed for 12 months, and at the end of the trial, the participant can continue to use the IUD\u002FIUS or the study clinician can remove it.",[587],"Vaginal Microbial Diversity",[589,590,591,592,593,594,595,596,597],"IUD","IUS","intrauterine devices","Copper intrauterine device","Long-acting reversible contraception","contraception","Women","STI prevention","STI","2026-06-02",{"date":568,"type":42},{"date":207,"type":24},{"date":602,"type":24},"2030-07",{"name":604,"class":49},"Seattle Children's Hospital",{"id":606,"slug":607,"hasResults":12,"nctId":608,"briefTitle":609,"officialTitle":610,"acronym":611,"eligibilityCriteria":612,"healthyVolunteers":12,"sex":141,"minAge":613,"maxAge":4,"enrollmentInfo":614,"targetDuration":4,"studyType":25,"phases":616,"briefSummary":617,"conditions":618,"keywords":629,"overallStatus":203,"whyStopped":4,"lastUpdateSubmitDate":634,"lastUpdatePostDateStruct":635,"startDateStruct":636,"completionDateStruct":637,"leadSponsor":639,"locationsCount":133},"100634904","phase-2-adjuvant-5-fluorouracil-following-thermal-ablation-to-improve-hpv-treatment-outcomes-in-women-with-hiv-in-kenya-100634904","NCT07545746","Adjuvant 5-Fluorouracil Following Thermal Ablation to Improve HPV Treatment Outcomes in Women With HIV in Kenya","Adjuvant 5-Fluorouracil Following Thermal Ablation to Improve HPV Treatment Outcomes in Women With HIV in Kenya : The ASCEND Trial","ASCEND","Inclusion Criteria\n\n* Women aged 25 years or older\n* Known HIV-positive status\n* On antiretroviral therapy (ART) for at least 60 days prior to enrollment\n* Positive HPV screening test screening result\n* Able to provide informed consent in English, Swahili, or Dholuo\n* Agree to use dual contraception during dosing phase if of childbearing potential\n* Planning to remain in study locale for duration of study (48 weeks) Exclusion Criteria\n* Current pregnancy or breastfeeding\n* History of anogenital cancer (cervical, vulvar, or anal)\n* Current use of immunosuppressive medications\n* History of total hysterectomy\n* Known allergy to 5FU\n* Medical comorbidity that would interfere with study participation\n* Unwilling or unable to use contraception during study participation","25 Years",{"count":615,"type":24},140,[243],"This randomized, placebo-controlled trial will evaluate self-administered 5-fluorouracil (5FU) to improve human papillomavirus (HPV) clearance after thermal ablation (TA) in Women With Human Immunodeficiency Virus (HIV) (WWH) in Kenya. The trial will also assess the safety, adherence, and acceptability of 5FU. Starting four weeks after TA, participants will self-administer 5FU cream or matched placebo intravaginally once every other week for 12 applications, with clinic visits at weeks 2, 8, 16, 24, and 48 for evaluation. All participants will be followed up to 48 weeks.\n\nIt is hypothesized that, compared to placebo, 5FU will increase HPV clearance at 24 weeks and that the proposed dosing schedule will be safe, well-tolerated, and acceptable in this population. Together with data from other studies, this trial will provide evidence on the use of self-administered intravaginal 5FU to improve HPV treatment outcomes in WWH in low- and middle-income countries, where the burden of cervical cancer is highest.",[619,620,621,622,623,624,625,626,627,628],"HIV Infections","HPV Infection","Cervix Cancer","CIN2","CIN3","CIN1","CIN","Cervical Intraepithelial Neoplasia Grade 3","Cervical Intraepithelial Neoplasia Grade 1","Cervical Intraepithelial Neoplasia Grade 2\u002F3",[630,631,632,633],"5-fluorouracil (5FU)","thermal ablation (TA)","placebo","intravaginal topical","2026-06-01",{"date":598,"type":42},{"date":207,"type":24},{"date":638,"type":24},"2028-03",{"name":640,"class":49},"UNC Lineberger Comprehensive Cancer Center",{"id":642,"slug":643,"hasResults":12,"nctId":644,"briefTitle":645,"officialTitle":646,"acronym":4,"eligibilityCriteria":647,"healthyVolunteers":12,"sex":19,"minAge":332,"maxAge":4,"enrollmentInfo":648,"targetDuration":4,"studyType":25,"phases":650,"briefSummary":651,"conditions":652,"keywords":654,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":634,"lastUpdatePostDateStruct":657,"startDateStruct":658,"completionDateStruct":660,"leadSponsor":662,"locationsCount":663},"100468742","phase-2-trial-of-a-six-month-regimen-of-high-dose-rifampicin-high-dose-isoniazid-linezolid-and-pyrazinamide-versus-a-standard-nine-month-regimen-for-the-treatment-of-adults-and-adolescents-with-tuberculous-meningitis-100468742","NCT05383742","Trial of a Six-Month Regimen of High-Dose Rifampicin, High-Dose Isoniazid, Linezolid, and Pyrazinamide Versus a Standard Nine-Month Regimen for the Treatment of Adults and Adolescents With Tuberculous Meningitis","A Phase II, Randomized, Open-Label Trial of a Six-Month Regimen of High-Dose Rifampicin, High-Dose Isoniazid, Linezolid, and Pyrazinamide Versus a Standard Nine-Month Regimen for the Treatment of Adults and Adolescents With Tuberculous Meningitis: Improved Management With Antimicrobial AGents Isoniazid rifampiciN LinEzolid for TBM (IMAGINE-TBM)","Inclusion Criteria:\n\n* Definite, probable, or possible TBM diagnosis wherein the participant is being committed to a full course of SOC anti-TB treatment for TBM in the setting of routine care. CSF, imaging, laboratory, and other results used to determine definite, probable, or possible TBM can be from testing performed as part of routine care, as long as obtained within 21 days prior to study entry\n* Absence of HIV-1 infection, as documented by any licensed rapid HIV test or HIV-1 enzyme or chemiluminescence immunoassay (E\u002FCIA) test kit, within 30 days prior to study entry, OR\n* HIV-1 infection, documented by any licensed rapid HIV test or HIV-1 E\u002FCIA test kit at any time prior to entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and\u002For E\u002FCIA, or by HIV-1 antigen or plasma HIV-1 RNA viral load. Two or more HIV-1 RNA viral loads of \\>1,000 copies\u002FmL are also acceptable as documentation of HIV-1 infection, or documentation of HIV diagnosis in the medical record by a healthcare provider\n* Documentation within 3 days prior to study entry of stage of disease using BMRC TBM grade.\n* The following laboratory values obtained within 3 days prior to study entry:\n\n  * Serum creatinine ≤1.8 times upper limit of normal (ULN)\n  * Hemoglobin ≥8.0 g\u002FdL for men, ≥7.5 g\u002FdL for women\n  * Absolute neutrophil count ≥600\u002Fmm3\n  * Platelet count ≥60,000\u002Fmm3\n  * Alanine aminotransferase (ALT) ≤3 x ULN\n  * Total bilirubin ≤2 x ULN\n* For participants of reproductive potential who have not been post-menopausal for at least 24 consecutive months (i.e., no menses within the preceding 24 months), or participants who have not undergone surgical sterilization, hysterectomy, bilateral salpingectomy, bilateral oophorectomy, or tubal ligation, documentation of a serum or urine pregnancy test result (positive or negative; see protocol for test sensitivity requirement) within 21 days prior to study entry\n* Participants with documentation of a positive pregnancy test will be consented using the consent form for pregnant participants.\n\nParticipants of reproductive potential with documentation of a negative pregnancy test must agree to use at least one acceptable form of contraception, or abstain from sexual activity that could lead to pregnancy while receiving study treatment and for 30 days after stopping study treatment.\n\nParticipants who are not of reproductive potential or whose partner(s) has documented azoospermia are not required to use contraception. Any statement of self-reported sterility or that of the partner's must be entered in the source documents\n\n* Ability and willingness of participant or parent or legally authorized representative (for adolescents or participants unable to provide consent) to provide informed consent\u002Fassent\n* Ability to comply with the protocol requirements in the opinion of the site investigator\n\nExclusion Criteria:\n\n* More than 14 cumulative days of first-line TB medications, including but not limited to INH, RIF, EMB, and PZA, received within 90 days prior to study entry\n* Known current or previous drug resistant TB infection (i.e., resistance to one or more first-line TB medications, including but not limited to INH, RIF, EMB, LZD and PZA)\n* Known allergy\u002Fsensitivity or any hypersensitivity to components of study TB drugs (INH, RIF, LZD, PZA, and EMB) or their formulation\n* For participants who are able to undergo the Brief Peripheral Neuropathy Screen (BPNS) within 21 days prior to study entry, Grade 3 subjective peripheral neuropathy score on the BPNS AND EITHER vibratory loss OR absent ankle jerks\n* Expected concomitant use or use up to 21 days prior to study entry of monoamine oxidase inhibitors or selective serotonin reuptake inhibitors, or concomitant use of any other drug with significant interaction with the study drugs (See protocol)\n* For participants with HIV who are ART-naïve or who are not regularly taking ART, planned initiation or reinitiation of ART during screening or during the first 4 weeks after initiation of TB therapy\n* For participants with HIV and on ART that includes a protease inhibitor, nevirapine, or other prohibited ART (see protocol), contraindication to switching to an acceptable alternative regimen (e.g., efavirenz, high-dose raltegravir or dolutegravir with nucleoside reverse transcriptase inhibitors, as per local SOC) prior to randomization. TB treatment, including study drugs, should be started as soon as possible\n* Contraindication to LP at discretion of treating clinician (e.g., unequal pressures between intracranial compartments due to mass lesion, non-communicating hydrocephalus)\n* Positive cryptococcal antigen, gram stain, bacterial culture, or other test result obtained from a CSF specimen collected within 21 days prior to entry as part of routine care indicating CNS infection with a pathogen other than Mtb (e.g., cryptococcal meningitis, bacterial meningitis).",{"count":649,"type":24},330,[243],"The purpose of this study is to compare a 6-month regimen of high-dose rifampicin (RIF), high-dose isoniazid (INH), linezolid (LZD), and pyrazinamide (PZA) versus the World Health Organization (WHO) standard of care (SOC) treatment for tuberculosis meningitis (TBM).",[653],"Tuberculous Meningitis",[655,461,656],"Tuberculosis, meningeal","CNS Disease",{"date":598,"type":42},{"date":659,"type":42},"2023-12-07",{"date":661,"type":24},"2029-09-15",{"name":283,"class":284},18,{"id":665,"slug":666,"hasResults":12,"nctId":667,"briefTitle":668,"officialTitle":669,"acronym":4,"eligibilityCriteria":670,"healthyVolunteers":18,"sex":141,"minAge":613,"maxAge":671,"enrollmentInfo":672,"targetDuration":4,"studyType":25,"phases":674,"briefSummary":675,"conditions":676,"keywords":4,"overallStatus":203,"whyStopped":4,"lastUpdateSubmitDate":679,"lastUpdatePostDateStruct":680,"startDateStruct":682,"completionDateStruct":683,"leadSponsor":685,"locationsCount":50},"100570523","enhancing-cervical-cancer-screening-and-treatment-in-women-living-with-hiv-in-kenya-the-enhance-linkage-trial-100570523","NCT06708351","Enhancing Cervical Cancer Screening and Treatment in Women Living With HIV in Kenya, the ENHANCE LINKAge Trial","Enhancing Cervical Cancer Screening and Treatment in Women Living With HIV in Kenya (ENHANCE LINKAGE)","Inclusion Criteria:\n\n* AIM 1 (PATIENTS): Aged 25-49 years\n* AIM 1 (PATIENTS): Female\n* AIM 1 (PATIENTS): Willing to participate in a 90-minute audio-recorded focus group discussion (FGD) and\n* AIM 1 (PATIENTS): Speak English or Swahili\n* AIM 1 (NURSES, CLINICAL STAFF, ADMINISTRATORS): Aged 18 years or older\n* AIM 1 (NURSES, CLINICAL STAFF, ADMINISTRATORS): Involved in implementing intervention components\n* AIM 1 (STAKEHOLDERS): Adults (aged \\>= 18 years) who are healthcare system users, support persons, healthcare providers and administrators, representatives of the government, professional associations, and non-governmental and faith-based organizations\n* AIMS 2 AND 3 (CLINIC PROVIDERS): Aged 18 years and older involved in CC screening, triage, and treatment\n* AIMS 2 AND 3 (WOMEN LIVING WITH HIV): Ages 25-49 years\n\nExclusion Criteria:\n\n* AIM 1: Stakeholder Advisory Board (SAB) members who are not engaged in CC work, individuals who have recently retired from the selected clinics, and patients who are attending the clinic for the first time will be excluded from the study\n* AIMS 2 AND 3 (WOMEN LIVING WITH HIV): Pregnant women, women =\\\u003C 6 weeks postpartum, and women already confirmed to have cervical cancer will be excluded","49 Years",{"count":673,"type":24},2280,[27],"Background In sub-Saharan Africa (SSA), human papillomavirus (HPV) and HIV create a dual burden of disease that causes significant morbidity and mortality in the form of cervical cancer (CC). Women living with HIV (WLWH) have a six-fold higher risk of developing precancerous lesions that persist and progress to CC, which is the leading cause of cancer mortality among women in Kenya. Significant support from the Go Further campaign, represented by donors such as the President's Emergency Plan for AIDS Relief (PEPFAR), the George W. Bush Institute, UNAIDS, Merck, and Roche, to integrate CC screening into HIV clinics represents an exceptional opportunity to scale CC impact across SSA, but only if implementation science evidence is available to inform strategy. Currently, the impact of Go Further has been undermined by fractured linkages to care and insensitive screening methods; in Kenya, less than 2% of WLWH screened have received appropriate treatment. Implementation science studies are needed to better understand and surmount barriers to integrated care in publicly funded HIV clinics.\n\nBroad objective This study seeks to explore and innovate strategies to overcome patient-, provider-, and system-level barriers to implementing CC screening and referral guidelines, link WLWH who require further diagnostic testing and\u002For treatment with effective and accessible care, and document services for accountability and quality improvement. In this proposal, our team will apply our extensive implementation science expertise and partnerships with Kenya Ministry of Health (MOH) to adapt and test evidence-based strategies (e.g., HPV self-testing, care navigators, and the WEMA mHealth app \\[tested and scaled in Tanzania\\]) that address key multi-level barriers identified through a formative, stakeholder-engaged research phase.\n\nMethodology Using the EPIS framework to guide our project, we will: Aim 1a), Explore (engage a multi-disciplinary stakeholder advisory board to co-design the intervention package and prioritize implementation strategies that align with local capacity, opportunities, and motivations; Aim 1b), Prepare (develop tools and strengthen capacity at clinics to implement the strategies; Aim 2), Implement and evaluate the package of implementation strategies via a cluster-randomized stepped wedge trial in 9 clinics (assessing implementation \\[provision of CC screening with HPV self-testing\\] and effectiveness \\[proportion of HPVpositive WLWH who receive subsequent diagnostic triage and\u002For treatment\\] over months 0-12; and Aim 3), assess Sustainability (costs, cost-effectiveness, and transfer of delivery from study to local staff over months 13-18.\n\nSignificance of the study The overall goal of this study is to employ rigorous empirical methods to adapt and test implementation strategies that expand the scope of HIV care to screen for and treat early precancerous CC lesions in a sustainable, scalable way. Through partnering with Kenya's MOH, this project will have critical institutional support and dissemination capability, and will directly inform public health practice and policy.",[412,677,678],"Human Papillomavirus-Related Cervical Carcinoma","Screening Strategy","2026-05-28",{"date":681,"type":42},"2026-05-29",{"date":474,"type":24},{"date":684,"type":24},"2030-08-31",{"name":686,"class":49},"Emory University",""]