[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Uganda\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":631},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,114,0,25,[9,44,78,98,125,146,177,202,232,256,292,313,332,358,378,399,419,442,460,483,512,532,559,582,607],{"id":10,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100053888",false,"NCT07606131","Testing a Registry-Based Strategy (ACT+) to Reduce Loss to Follow-Up in Rheumatic Heart Disease Screening in Uganda","Developing and Testing a Registry-Enabled Strategy (ACT+) to Reduce Loss to Follow-Up Between Screening and Confirmation of Rheumatic Heart Disease in Uganda","SHIELD 2","Inclusion Criteria: Community Members\n\n* 18 years of age or older\n* Received a positive ADUNU echocardiographic screening result within the past 24 months OR parent\u002Flegal guardian of a minor who received a positive ADUNU echocardiographic screening result within the past 24 months\n\nInclusion Criteria: Providers\n\n* Employed at an ADUNU-participating facility or confirmatory echo facilities at the time of study\n* Holds a designated ADUNU role (nurse screener, confirmatory provider, or referral support staff) or is involved in RHD screening, diagnosis or care\n* Ability to provide informed consent in Acholi, Luo, or English\n\nInclusion Criteria: Regional RHT ACT Nurse Coordinator\n\n* Employed as a Regional ACT Nurse at the time of study\n* Has familiarity with ADUNU program\n* Ability to provide informed consent in Acholi, Luo, or English\n\nInclusion Criteria: District Health Office Team Members and District RHD Focal Persons\n\n* Employed at District Health Office within an ADUNU-participating district\n* Has familiarity with ADUNU program\n* Ability to provide informed consent in Acholi, Luo, or English\n\nExclusion Criteria:\n\n* No formal exclusion criteria beyond inability to provide informed consent. Individuals with significant cognitive or communication impairment precluding interview participation will not be enrolled.",true,"ALL",{"count":20,"type":21},16,"ESTIMATED","INTERVENTIONAL",[24],"NA","This study aims to improve follow-up care after positive rheumatic heart disease (RHD) screening in Northern Uganda. It will identify barriers and co-develop an enhanced ACT+ strategy, then evaluate its effectiveness in increasing linkage to confirmatory echocardiography, along with its adoption, acceptability, and feasibility. Secondary outcomes include time to diagnosis, initiation of treatment, and factors influencing implementation.",[27],"Rheumatic Heart Disease",[29,30],"Rheumatic heart disease","SHIELD","NOT_YET_RECRUITING","2026-07-10",{"date":34,"type":35},"2026-07-13","ACTUAL",{"date":37,"type":21},"2026-08-01",{"date":39,"type":21},"2028-06-01",{"name":41,"class":42},"Children's Hospital Medical Center, Cincinnati","OTHER",1,{"id":45,"slug":4,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":17,"sex":18,"minAge":51,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"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","18 Years",{"count":53,"type":21},300,[24],"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.",[57],"Kaposi Sarcoma",[59,57,60,61,62,63,64,65,66],"Global Oncology","Affordable Cancer Technologies","Cancer in People with HIV","Human Centered Design","Discrete Choice Experiment","Medical devices","Low-cost design","Global health","RECRUITING","2026-06-29",{"date":70,"type":35},"2026-07-01",{"date":72,"type":35},"2026-04-10",{"date":74,"type":21},"2029-11-30",{"name":76,"class":42},"Washington University School of Medicine",2,{"id":79,"slug":4,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":17,"sex":18,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":22,"phases":87,"briefSummary":88,"conditions":89,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":91,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":43},"100580318","NCT06835738","Implementation of Multiple Micronutrient Supplementation (MMS) for Pregnant Women in Uganda","Inclusion Criteria for Pregnant women- Enrolled for follow-up throughout pregnancy (sample 1)\n\n* ≤24 weeks of amenorrhea\u002Fgestation as verified by health professionals\n* Attending first ANC visit at government or PNFP health facilities.\n* Accepted to take MMS at first ANC visit\n\nExclusion Criteria for Pregnant women- Enrolled for follow-up throughout pregnancy (sample 1)\n\n* Pregnant women with pre-existing hematological conditions such as sickle cell anemia, thalassemia, hemochromatosis.\n* Pregnant women planning to relocate outside the study district during the study period.\n\nInclusion Criteria for Pregnant women \u002F Women that have recently delivered (single contact) (sample 2)\n\n* Currently pregnant woman or a woman who is not more than 8 weeks postpartum.\n* Received MMS at an ANC visit at least 3 months ago or more.\n* Attended at least any 2 monthly ANC visits.\n* Attending\u002Fattended ANC at government or private-not-for-profit health facility.\n\nExclusion Criteria for Pregnant women \u002F Women that have recently delivered (single contact) (sample 2)\n\n* Enrolled in study population 1.\n* Women who are more than 8 weeks postpartum.\n\nInclusion Criteria for ANC providers having ANC health education\u002Fcounseling with pregnant woman(en) observed (sample 3)\n\n• Healthcare providers that are currently providing ANC health education (group) or ANC individual counseling at government or PNFP health facilities.\n\nExclusion Criteria for ANC providers having ANC health education\u002Fcounseling with pregnant woman(en) observed (sample 3) • Healthcare providers that are currently providing ANC health education (group) or ANC individual counseling to a woman(en) that have not provided written informed consent to have the ANC session observed.\n\nInclusion Criteria for Influential family members (male partners \\& mothers\u002Fmothers-in law) (sample 4)\n\n* Spouse or partner of a pregnant woman or woman with a child less than 8 weeks old who is receiving\u002F has received ANC services in one of the 8 study districts.\n* Mother or mother-in-law of a pregnant woman or woman with a child less than 8 weeks old who is receiving\u002F has received ANC services in one of the 8 study districts.\n\nExclusion Criteria for Influential family members (male partners \\& mothers\u002Fmothers-in law) (sample 4) • None\n\nInclusion Criteria for Healthcare Providers- including facility in-charge, ANC providers, Health Assistants, staff in-charge of records, and stores manager (sample 5)\n\n* Health workers who provide ANC services (e.g., midwives\u002Fnurse, medical\u002F clinical officers, health assistants, and nutrition focal person) at government or private-not-for-profit facilities in one of the 8 study districts.\n* Health facility staff (e.g., Facility In-charge, Maternity In-charge, Pharmacy\u002FStores In-charge) at government or private-not-for-profit facilities in one of the 8 study districts.\n\nExclusion Criteria for Healthcare Providers- including facility in-charge, ANC providers, Health Assistants, staff in-charge of records, and stores manager (sample 5)\n\n• None\n\nInclusion Criteria for Community Health Workers (VHTs) and Mentor Mothers (sample 6) • Voluntary Health Team (VHT), Mentor Mothers, or Para-socials attached to at least one of the study facilities.\n\nExclusion Criteria for Community Health Workers (VHTs) and Mentor Mothers (sample 6) • None\n\nInclusion Criteria for National, regional, and district-level stakeholders (sample 7)\n\n* National, regional, or district-level decision-makers working in nutrition, maternal, newborn and child health, district health educator or pharmaceutical roles associated with the antenatal care system in Uganda.\n* Implementing partners involved in direct implementation of MMS within the 8 study districts\n\nExclusion Criteria for National, regional, and district-level stakeholders (sample 7)\n\n• None\n\nInclusion Criteria for Pregnant women - interviewed during post-intervention Household Coverage Survey (sample 8)\n\n* Woman who has been pregnant or delivered within the study period.\n* Household is within one of the 4 selected districts.\n\nExclusion Criteria for Pregnant women - interviewed during post-intervention Household Coverage Survey (sample 8)\n\n• Women who moved to the district after delivery.","0 Years","80 Years",{"count":86,"type":21},4077,[24],"The objective of this research is to understand how antenatal multiple micronutrient supplements (MMS) can be effectively implemented and scaled within the Uganda national health system context to support improved maternal nutrition and birth outcomes. Formative research has been conducted to design the implementation strategies that will be tested in this second phase of the study. The objectives are to:\n\n* Describe the implementation of the MMS intervention (which consists of MMS product, a social behavior change communication (SBCC) strategy, capacity building, MMS supply chain support, monitoring, and evaluation) and explore acceptability, feasibility, fidelity, coverage, and potential for sustainability.\n* Determine the effect of dispensing MMS in different bottle counts on MMS adherence and ANC attendance among pregnant women.\n* Determine the cost and budget impact of MMS intervention implementation integrated in the Ugandan ANC service delivery system",[90],"Nutrient Deficiency",{"date":70,"type":35},{"date":93,"type":35},"2025-06-18",{"date":95,"type":21},"2026-12-31",{"name":97,"class":42},"Johns Hopkins Bloomberg School of Public Health",{"id":99,"slug":4,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":17,"sex":104,"minAge":105,"maxAge":106,"enrollmentInfo":107,"targetDuration":4,"studyType":22,"phases":109,"briefSummary":111,"conditions":112,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":124},"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":108,"type":21},4580,[110],"PHASE3","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",[113,114],"Human Immunodeficiency Virus (HIV)","HIV Pre-Exposure Prophylaxis","2026-06-26",{"date":68,"type":35},{"date":118,"type":35},"2025-11-10",{"date":120,"type":21},"2027-10-18",{"name":122,"class":123},"Merck Sharp & Dohme LLC","INDUSTRY",30,{"id":126,"slug":4,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":130,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":18,"minAge":51,"maxAge":4,"enrollmentInfo":132,"targetDuration":4,"studyType":22,"phases":134,"briefSummary":135,"conditions":136,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":138,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":145},"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":133,"type":21},230,[110],"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).",[137],"Metastatic Breast Cancer",{"date":68,"type":35},{"date":140,"type":35},"2023-09-08",{"date":142,"type":21},"2032-12-28",{"name":144,"class":123},"Hoffmann-La Roche",192,{"id":147,"slug":4,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":151,"eligibilityCriteria":152,"healthyVolunteers":11,"sex":18,"minAge":153,"maxAge":4,"enrollmentInfo":154,"targetDuration":4,"studyType":156,"phases":4,"briefSummary":157,"conditions":158,"keywords":161,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":176},"100642705","NCT07651865","Holistic Approach Supporting the Uptake of Innovative Diagnostic Technologies for Respiratory Infections","Clinical Validation of Novel Microfluidic and Lateral Flow-based Technologies for the Detection of Lower and Upper Respiratory Tract Infections - HOLICARE Trial","HOLICARE","Inclusion Criteria:\n\n* Age ≥ 6 months\n* Presentation with suspected respiratory tract infection and at least two of the following symptoms:\n* Fever (axillary temperature ≥37.5°C) or history of fever\n* New acute cough episode\n* Shortness of breath\n* Tachypnoea (fast breathing)\n* Loss of smell and\u002For taste\n* Ability to provide written informed consent (or assent with parent\u002Fguardian consent for minors)\n* For infants (≤1 year), both fever and new acute cough must be present at screening\n\nExclusion Criteria:\n\n* Refusal or inability to provide informed consent\u002Fassent\n* Refusal to provide study samples\n* Severe chronic medical conditions or mental incapacity that, in the opinion of the clinician, would interfere with study participation\n* Hospitalisation within the previous 2 weeks for reasons unrelated to the current respiratory symptoms\n* Acute injury, trauma, or poisoning interfering with participation\n* Chronic cough lasting \\>2 weeks, unless tuberculosis is suspected in the LRTI cohort\n* Antibiotic use within the previous 2 weeks for participants enrolled in the LRTI cohort (Sub-study 2) only","6 Months",{"count":155,"type":21},2160,"OBSERVATIONAL","This observational diagnostic validation study aims to evaluate the clinical performance of novel lateral flow and microfluidic-based technologies for the detection of upper and lower respiratory tract infections in children and adults presenting with respiratory symptoms in Uganda, Ethiopia, and Senegal. The main questions it aims to answer are:\n\n1. whether the novel multiplex lateral flow tests and point-of-care microfluidic platform demonstrate sufficient sensitivity and specificity for detecting respiratory pathogens compared with standard laboratory reference methods, and\n2. whether these technologies are feasible and usable in low-resource clinical settings.\n\nParticipants presenting with suspected respiratory tract infections as part of routine clinical care will provide respiratory and blood samples for diagnostic testing and biobanking, and demographic and clinical information will be collected during a single study visit. Some adult participants and community stakeholders will also complete surveys or interviews regarding the acceptability of biobanking and diagnostic implementation.",[159,160],"Upper Respiratory Infection","Lower Resp Tract Infection",[162,163,164,165,166,167],"Point of Care","POC","Later Flow Test (LFT)","Global Health","Rapid diagnostic","Microfluidics","2026-06-24",{"date":68,"type":35},{"date":171,"type":35},"2025-04-07",{"date":173,"type":21},"2026-08-31",{"name":175,"class":42},"Karolinska Institutet",3,{"id":178,"slug":4,"hasResults":11,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":182,"eligibilityCriteria":183,"healthyVolunteers":11,"sex":18,"minAge":51,"maxAge":4,"enrollmentInfo":184,"targetDuration":4,"studyType":22,"phases":186,"briefSummary":188,"conditions":189,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":201},"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":185,"type":21},315,[187],"PHASE2","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.",[190],"Pulmonary Tuberculosis","2026-06-22",{"date":193,"type":35},"2026-06-23",{"date":195,"type":35},"2025-03-11",{"date":197,"type":21},"2027-08-11",{"name":199,"class":200},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",29,{"id":203,"slug":4,"hasResults":11,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":207,"eligibilityCriteria":208,"healthyVolunteers":11,"sex":18,"minAge":209,"maxAge":4,"enrollmentInfo":210,"targetDuration":4,"studyType":22,"phases":212,"briefSummary":213,"conditions":214,"keywords":216,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":231},"100373655","NCT04145258","Intensified Tuberculosis Treatment to Reduce the Mortality of Patients With Tuberculous Meningitis","Intensified Tuberculosis Treatment to Reduce the Mortality of HIV-infected and Uninfected Patients With Tuberculosis Meningitis: a Phase III Randomized Controlled Trial (Acronym: INTENSE-TBM)","INTENSE-TBM","Inclusion criteria:\n\n1. Age ≥ 15 years\n2. TBM defined as \"definite\", \"probable\" or \"possible\"\n3. Signed Informed Consent\n\n   * Definite TBM = at least one of the following criteria: acid-fast bacilli seen in CSF microscopy, positive CSF M. tuberculosis culture, or positive CSF M. tuberculosis commercial nucleic acid amplification test.\n   * Probable TBM = total modified Marais score ≥12 when neuroimaging is available, or ≥10 when neuroimaging is not available (at least 2 points should come from CSF or cerebral imaging criteria).\n   * Possible TBM = total modified Marais 6-11 when neuroimaging is available, or 6-9 when neuroimaging is not available.\n\nExclusion criteria:\n\n* \\> 5 days of TB treatment\n* Renal failure (eGFR\\\u003C30 ml\u002Fmin, CKD-EPI formula).\n* Neutrophil count \\\u003C 0.6 x 109\u002FL.\n* Hemoglobin concentration \\\u003C 8 g\u002FdL.\n* Total bilirubin \\> 2.6 times the Upper Limit of Normal\n* Platelet count \\\u003C 50 x 109\u002FL.\n* ALT \\> 5 times the Upper Limit of Normal.\n* Clinical evidence of liver failure or decompensated cirrhosis.\n* For women: more than 17 weeks pregnancy or breastfeeding.\n* For patients without decrease level of consciousness (Glasgow Coma Scale = 15): Peripheral neuropathy scoring Grade 3 or above on the Brief Peripheral Neuropathy Score (BPNS).\n* Documented M. tuberculosis resistance to rifampicin.\n* Positive gram-stain, bacterial culture or cryptococcal antigen in the Cerebral Spinal Fluid.\n* Evidence of active bleeding (hemoptysis, gastrointestinal bleeding, hematuria, intracranial bleeding).\n* Inability to collect Cerebral Spinal Fluid, except for patients with confirmed tuberculosis (by rapid molecular test or culture) from another biological sample and clinical and\u002For CT scan evidence of meningitis.\n* Major surgery within the last two weeks prior to inclusion.\n* Ongoing chronic aspirin treatment (eg for cardiovascular risk).\n* Current use of drugs contraindicated with study drugs and that cannot be safely stopped (see Appendix 1: Drugs contra-indicated with study drugs).\n* In available history from patients:\n\n  * Evidence of past intracranial bleeding.\n  * Evidence of past of peptic ulceration.\n  * Evidence of recent (\\\u003C 3 month) gastrointestinal bleeding.\n  * Known hypersensitivity contraindicating the use of study drugs .\n  * Evidence of porphyria.\n  * Evidence of hyperuricemia or gout.\n* Any reason which at the discretion of the investigator would compromise safety and cooperation in the trial.","15 Years",{"count":211,"type":21},768,[110],"INTENSE-TBM is randomized controlled, phase III, multicenter, 2 x 2 factorial plan superiority trial assessing the efficacity of two interventions to reduce mortality from tuberculous meningitis (TBM) in adolescents and adults with or without HIV-infection in sub-Saharan Africa:\n\n* Intensified TBM treatment with high-dose rifampicin and linezolid, compared to WHO standard TBM treatment.\n* Aspirin, compared to not receiving aspirin. The trial will be open-label for anti-TB treatment and placebo-controlled for aspirin treatment.",[215],"Tuberculous Meningitis",[215,217,218,219,220,221],"Intensified treatment","High dose Rifampicin","Linezolid","Aspirin","Subsaharan Africa","2026-06-21",{"date":168,"type":35},{"date":225,"type":35},"2021-02-07",{"date":227,"type":21},"2026-09-26",{"name":229,"class":230},"ANRS, Emerging Infectious Diseases","OTHER_GOV",13,{"id":233,"slug":4,"hasResults":11,"nctId":234,"briefTitle":235,"officialTitle":235,"acronym":236,"eligibilityCriteria":237,"healthyVolunteers":11,"sex":18,"minAge":238,"maxAge":239,"enrollmentInfo":240,"targetDuration":4,"studyType":22,"phases":242,"briefSummary":243,"conditions":244,"keywords":245,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":250,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":43},"100604171","NCT07146048","A Non-Inferiority Trial of Stopping Penicillin in Early Rheumatic Heart Disease: GOAL-Stop","GOAL-Stop","Inclusion Criteria:\n\n* Participated in GOALIE\n* Concluded GOALIE with either echocardiographic normalization or stable mild RHD\n* Between ages 5-20 years at time of enrollment\n\nExclusion Criteria:\n\n* RHD Stage C\u002FD at GOALIE end of study echocardiogram\n* Relocation to extremely distant residence or school\n* Clinically documented penicillin allergy","5 Years","20 Years",{"count":241,"type":21},922,[110],"GOAL-Stop is a randomized, controlled, non-inferiority trial designed to evaluate whether discontinuing secondary antibiotic prophylaxis (SAP) is non-inferior to continuing SAP in preventing progression of rheumatic heart disease (RHD) among children and adolescents. The trial will enroll participants aged 5-20 years with previously diagnosed mild RHD who have received at least 2 years of SAP and who demonstrate either echocardiographic normalization or stability (persistent mild RHD). Participants will be randomized to either continue SAP or discontinue SAP for 2 years. The primary outcome is echocardiographic progression of RHD at 2 years, assessed by blinded adjudicators using the 2023 World Heart Federation criteria. Subgroup analyses will evaluate outcomes in participants with echocardiographic normalization versus stable mild RHD, and an exploratory analysis will assess whether outcomes differ by prior prophylaxis route (oral vs. intramuscular).",[27],[29,246,247,248],"global health","secondary prophylaxis","children","2026-06-18",{"date":191,"type":35},{"date":252,"type":35},"2026-03-23",{"date":254,"type":21},"2029-12-31",{"name":41,"class":42},{"id":257,"slug":4,"hasResults":11,"nctId":258,"briefTitle":259,"officialTitle":260,"acronym":261,"eligibilityCriteria":262,"healthyVolunteers":11,"sex":18,"minAge":263,"maxAge":264,"enrollmentInfo":265,"targetDuration":4,"studyType":22,"phases":266,"briefSummary":267,"conditions":268,"keywords":270,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":284,"startDateStruct":285,"completionDateStruct":287,"leadSponsor":289,"locationsCount":291},"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":185,"type":21},[110],"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.",[269],"Sickle Cell Disease",[269,271,272,273,274,275,276,277,278,279,280,281,282,283],"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",{"date":191,"type":35},{"date":286,"type":35},"2024-10-24",{"date":288,"type":21},"2030-04-19",{"name":290,"class":123},"Novartis Pharmaceuticals",32,{"id":293,"slug":4,"hasResults":11,"nctId":294,"briefTitle":295,"officialTitle":295,"acronym":4,"eligibilityCriteria":296,"healthyVolunteers":11,"sex":18,"minAge":51,"maxAge":297,"enrollmentInfo":298,"targetDuration":4,"studyType":156,"phases":4,"briefSummary":300,"conditions":301,"keywords":303,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":307,"startDateStruct":308,"completionDateStruct":310,"leadSponsor":312,"locationsCount":43},"100220972","NCT02154035","Quantitative Measurement and Correlates of the Latent HIV Reservoir in Virally Suppressed Ugandans","* INCLUSION CRITERIA:\n\n  1. At least 18 years of age\n  2. Hemoglobin \\>11g\u002FdL as assessed by fingerstick rapid test\n  3. Weight \\>40 kilograms\n  4. A historical diagnosis of HIV infection as indicated by any positive serological test (ELISA, HIV rapid test, or Western Blot)\n  5. Virally suppressed as defined as at least two historical viral loads \\\u003C40 copies\u002Fml obtained between 10-18 months apart, and no intervening detectable viral load result \\>= 40 copies\u002Fml obtained during this period\n  6. Most recent historical viral load result obtained within a year prior to the screening visit\n  7. Willingness to undergo genetic testing\n\nEXCLUSION CRITERIA:\n\n1. Women who are pregnant will be excluded as the required blood draw may cause anemia and because of perturbations due to hormonal or immunosuppressive states that could impact the reservoir.\n2. Inability to follow study instructions or to provide informed consent\n3. Any condition deemed by the investigators to be a contraindication to study participation including active, serious infections (other than HIV infection) during the 2 weeks prior to enrollment.\n4. Malignancies of any kind (e.g., Kaposi's sarcoma)\n5. Therapy with systemic steroids, immunosuppressants or immunomodulating agents\n6. Coagulation defects or other serious bleeding disorders\n7. Current use of medications which could affect clotting.","49 Years",{"count":299,"type":21},130,"Background:\n\nHuman Immunodeficiency Virus (HIV) is the virus that causes AIDS. HIV can hide in the blood for many years, even in people who have their HIV infection under control. HIV that is hiding in the blood is called the \"latent HIV reservoir.\" Researchers want to find out more about it in this study. This knowledge may help them develop new ways to prevent or control HIV. This study will draw its participants from the Rakai Health Sciences Program in rural southwestern Uganda.\n\nObjective:\n\n\\- To measure and learn about the latent HIV reservoir in Ugandans with HIV.\n\nEligibility:\n\n\\- Men and women at least 18 years of age with HIV.\n\nDesign:\n\n* Participants will have a medical history and physical exam. Their medical records will be reviewed. Researchers will ask participants about their health and recent illnesses. Participants able to get pregnant will have their urine tested for pregnancy.\n* Participants will have their finger pricked to see if they have enough red blood cells to be eligible for the study.\n* If eligible, participants will have blood drawn through a needle in the arm. Their blood will also be tested for other diseases.\n* After the blood draw, participants will be asked to stay seated or lying down if they are not feeling well for up to 30 minutes.",[302],"HIV",[304,305,306],"Viral Suppression","Functional Cure","Natural History",{"date":191,"type":35},{"date":309,"type":4},"2014-05-31",{"date":311,"type":21},"2027-06-09",{"name":199,"class":200},{"id":314,"slug":4,"hasResults":11,"nctId":315,"briefTitle":316,"officialTitle":317,"acronym":4,"eligibilityCriteria":318,"healthyVolunteers":11,"sex":18,"minAge":51,"maxAge":4,"enrollmentInfo":319,"targetDuration":4,"studyType":22,"phases":321,"briefSummary":322,"conditions":323,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":325,"startDateStruct":326,"completionDateStruct":328,"leadSponsor":330,"locationsCount":176},"100610453","NCT07227779","B-PaLMZ for TB Meningitis","A PHASE 2 NOVEL ANTIMICROBIAL COMBINATION THERAPY TO TREAT TUBERCULOUS MENINGITIS","Inclusion Criteria:\n\n* First Episode definite or probable TBM with physician intent to treat\n* Age ≥18 years\n* Provision of Informed Consent by participant or surrogate\n* Living with HIV\n* Weight \\> 35kg, estimate or measured\n\nExclusion Criteria:\n\n* Additional active and confirmed CNS infection\n* Known rifampicin-resistant TB\n* Allergy or contraindication to a study medicine\n* More than 5 doses of any TB therapy received within the previous 14 days\n* Presence of jaundice, known liver cirrhosis, elevated ALT or AST \\>3x ULN, or total bilirubin \\>2x ULN\n* Estimated Glomerular Filtration Rate \\\u003C30 ml\u002Fmin\u002F1.73m2\n* Significant cardiac comorbidity, heart failure, arrhythmia, or QTc \\>450 ms\n* Pregnancy or Breastfeeding\n* Cryptococcal antigen positivity in blood\n* Condition which makes participation not in the participant's best interest",{"count":320,"type":21},240,[187],"This two-stage study will compare consented research participants with tuberculous meningitis receiving BPaLMZ to controls receiving SOC of rifampicin (R), isoniazid (H), pyrazinamide (Z), and ethambutol (E), known as RHZE.",[215],"2026-06-17",{"date":191,"type":35},{"date":327,"type":21},"2026-07-20",{"date":329,"type":21},"2030-08-31",{"name":331,"class":42},"University of Minnesota",{"id":333,"slug":4,"hasResults":11,"nctId":334,"briefTitle":335,"officialTitle":336,"acronym":337,"eligibilityCriteria":338,"healthyVolunteers":11,"sex":18,"minAge":51,"maxAge":4,"enrollmentInfo":339,"targetDuration":4,"studyType":22,"phases":341,"briefSummary":342,"conditions":343,"keywords":346,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":351,"startDateStruct":352,"completionDateStruct":354,"leadSponsor":356,"locationsCount":43},"100585305","NCT06900634","Pilot of an Intervention to Reduce Alcohol Use and Improve ART Adherence Among Men Living With HIV With Pregnant Partners in Uganda.","Utilizing Implementation Research Methodologies to Adapt an Intervention to Reduce Alcohol Use and Improve HIV Care Outcomes Among Men Living With HIV Who Have Serodiscordant Pregnant Partners","Kisoboka Amaka","Inclusion Criteria:\n\nFOR MEN\n\n1. living with HIV;\n2. AUDIT-C positive (≥4) indicating potential hazardous drinking;\n3. \\>6 months since initial antiretroviral treatment (ART) initiation;\n4. an indicator of potential suboptimal treatment as prevention (TasP) either: (i) last HIV viral load test (within 6 months) was detectable (\\>20) or (ii) last viral load test between 6 and 13 months ago was detectable (\\>20) and reports missing ≥2 ART doses in the past 2 weeks or (iii) a lack of viral load test results for the prior 13 months in clinic records and reports missing ≥2 ART doses in the past 2 weeks\n5. not planning to move from the area within the next 6 months;\n6. have their own mobile phone and can be reached via phone.\n\nFOR WOMEN\n\n1. 18+ years of age (or emancipated minor)\n2. Pregnant\n3. HIV negative\n\nFOR COUPLES (IF INDIVIDUAL ELIGIBILITY CRITERIA ABOVE ARE MET)\n\n1. married\u002Fliving together \\>6 months;\n2. planning to stay together \\>6 months\n3. lived in the area for \\>3 months and\n4. not planning to move within \\\u003C6 months.\n5. similar responses on Couple Verification Screening (CVS) form, an instrument to determine if couples are legitimate (e.g., asking each person what they ate the last time they shared a meal with their partner).\n\nExclusion Criteria:\n\nFOR MEN\n\n1. visibly intoxicated at enrollment (eligible to enroll when not intoxicated);\n2. does not speak Luganda or English;\n3. currently receiving a majority of work payments via mobile money\u002Fdigital payments;\n4. participated in the Kisoboka pilot RCT;\n5. unable to read basic Luganda or English\n\nFOR WOMEN For safety purposes, we will not enroll women who do not feel they can safely participate in the study.",{"count":340,"type":21},60,[24],"Hazardous alcohol use, which is common among men in Uganda, is a primary driver of both HIV risk and intimate partner violence (IPV) in this setting. Among men living with HIV, alcohol use is associated with non-adherence to antiretroviral therapy (ART) and a detectable viral load, increasing the risk of onward HIV transmission to partners. This risk is further heightened when the partner is pregnant, due to the potential for vertical transmission. Therefore, addressing factors that interfere with optimal HIV care outcomes among men living with HIV is critical to HIV prevention in pregnant women.\n\nThe goal of this randomized controlled trial (RCT) is to pilot test an intervention that combines alcohol reduction and economic strengthening to improve ART adherence. The study will assess implementation outcomes and preliminary efficacy among men living with HIV who engage in hazardous alcohol use and their pregnant partners (n=30 couples). The main questions it aims to answer are:\n\n1. What are the implementation outcomes (acceptability, appropriateness, feasibility, fidelity, and safety) at the individual, implementer, and organizational levels, and what bridging factors may impede success (e.g., community-academic partnership)?\n2. Does the intervention reduce hazardous alcohol use and improve ART adherence among men living with HIV?\n\nResearchers will compare the intervention group (n=15 couples) to the standard of care group (n=15 couples) to determine if the intervention leads to behavior change in alcohol use and ART adherence among men living with HIV.\n\nParticipants will:\n\n1. Men in the intervention group will receive the Amaka intervention, designed to reduce alcohol use and improve ART adherence.\n2. Complete assessments on hazardous alcohol use, ART adherence, and implementation outcomes at multiple time points (baseline, 3 and 6 months).\n3. Engage with implementers to provide post-implementation feedback on feasibility and acceptability.",[344,345],"HIV Antiretroviral Therapy (ART) Adherence","Alcohol Consumption",[347,348,349,350],"hiv","motivational interviewing","behavioral economics","alcohol use disorder",{"date":191,"type":35},{"date":353,"type":21},"2027-02-01",{"date":355,"type":21},"2028-02-01",{"name":357,"class":42},"San Diego State University",{"id":359,"slug":4,"hasResults":11,"nctId":360,"briefTitle":361,"officialTitle":362,"acronym":363,"eligibilityCriteria":364,"healthyVolunteers":11,"sex":18,"minAge":51,"maxAge":4,"enrollmentInfo":365,"targetDuration":4,"studyType":22,"phases":367,"briefSummary":368,"conditions":369,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":372,"startDateStruct":373,"completionDateStruct":375,"leadSponsor":377,"locationsCount":77},"100567294","NCT06666322","Platform Trial For Cryptococcal Meningitis (PLATFORM-CM)","Platform Trial For Cryptococcal Meningitis","PLATFORM-CM","Inclusion Criteria:\n\n* CSF cryptococcal antigen (CrAg) positive meningitis\n* Living with HIV\n* Ability and willingness to provide informed consent\n* Willing to receive protocol-specified lumbar punctures\n* Age \\>= 18 years\n* Female participants of childbearing potential who are participating in sexual activity that could lead to pregnancy must agree to use reliable forms of contraception (duration will be indicated in each Trial Appendix).\n\nExclusion Criteria:\n\n* Received 3 or more doses of antifungal therapy for meningitis within last 30 days\n* Inability to take enteral (oral or nasogastric) medicine\n* Cannot or unlikely to attend regular clinic visits\n* Receiving chemotherapy or corticosteroids\n* Receiving hemodialysis or known liver cirrhosis\n* Suspected Paradoxical immune reconstitution inflammatory syndrome (IRIS)\n* Pregnancy or breastfeeding\n* Previous administration of investigational study drug\n* Any condition for which participation would not be in the best interest of the participant or that could limit protocol specified assessments\n* Trial Appendix study-drug specific eligibility criteria",{"count":366,"type":21},2000,[187,110],"Cryptococcal meningitis is a fungal infection that causes a severe syndrome of meningitis that is 100% fatal without antifungal therapy. Even with antifungal therapy, mortality rates remain high, especially in low and middle income countries where the ongoing HIV\u002FAIDS pandemic increases the risk of cryptococcosis among persons living with HIV infection. The combination of amphotericin and flucytosine (5-FC) has been the mainstay of therapy for the initial management of cryptococcal meningitis for 4 decades. Indeed, the effective delivery of these first line therapy in Africa can lower mortality to 25%. However, several challenges exist. First, even while 5-FC is included on the WHO list of essential medicines, the availability of 5-FC worldwide is limited. Second, liposomal amphotericin (Ambisome ®) is currently available from a single source supplier, creating risk. Third, current therapies have substantial toxicity. Lastly, with widespread agricultural fungicide use of azoles, the median fluconazole minimum inhibitory concentration (MIC50 ) for Cryptococcus has doubled since 2013. Globally, new or improved antifungals are needed for cryptococcal meningitis, particularly those which have less toxicity, greater efficacy, a prolonged half-life, and minimal drug-drug interactions. As multiple new antifungal medicines are on the horizon, this platform trial utilizes a master protocol to investigate, multiple regimens using standardized eligibility criteria, standardized study schedule of events, and standardized contemporary endpoints.",[370,371],"Hiv","Cryptococcal Meningitis",{"date":191,"type":35},{"date":374,"type":35},"2025-05-28",{"date":376,"type":21},"2032-04-21",{"name":331,"class":42},{"id":379,"slug":4,"hasResults":11,"nctId":380,"briefTitle":381,"officialTitle":382,"acronym":383,"eligibilityCriteria":384,"healthyVolunteers":11,"sex":18,"minAge":263,"maxAge":4,"enrollmentInfo":385,"targetDuration":4,"studyType":22,"phases":387,"briefSummary":388,"conditions":389,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":390,"lastUpdatePostDateStruct":391,"startDateStruct":392,"completionDateStruct":394,"leadSponsor":396,"locationsCount":398},"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":386,"type":21},408,[110],"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.",[269],"2026-06-16",{"date":324,"type":35},{"date":393,"type":35},"2025-02-17",{"date":395,"type":21},"2029-03-12",{"name":397,"class":123},"Novo Nordisk A\u002FS",174,{"id":400,"slug":4,"hasResults":11,"nctId":401,"briefTitle":402,"officialTitle":403,"acronym":4,"eligibilityCriteria":404,"healthyVolunteers":11,"sex":18,"minAge":4,"maxAge":405,"enrollmentInfo":406,"targetDuration":408,"studyType":156,"phases":4,"briefSummary":409,"conditions":410,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":411,"lastUpdatePostDateStruct":412,"startDateStruct":413,"completionDateStruct":415,"leadSponsor":417,"locationsCount":418},"100539288","NCT06301893","Uganda Sickle Surveillance Study (US-3)","Prevalence and Mapping of Sickle Cell Trait and Disease in Uganda","Inclusion Criteria:\n\n* Up to 1,000,000 samples may be collected during 2015 - 2030 following primary analysis based on surveillance findings.\n\nExclusion Criteria:\n\n* Repeat samples on the same individuals during the study period will be excluded.","12 Months",{"count":407,"type":21},1000000,"6 Years","It is estimated that over 250,000 babies are born with sickle cell disease (SCD) annually in sub-Saharan Africa, and only 10% - 50% of them survive beyond five years of age. Data describing the magnitude of the sickle cell problem are lacking in most African countries. The available data on prevalence were mainly from older studies and small numbers of hospitalized patients. In Uganda, approximately 25,000 children are born with SCD but 70-80% die before their 5th birthday. Lehmann and Raper found 'sicklaemia' prevalence of 0.8% and 45% in the Sebei and Bambaa ethnic groups, respectively. A recent study found a SCT and SCD prevalence of 3% - 19% and 0% - 3%, respectively but this study addressed only 5 of Uganda's 111 districts and used a small convenience sample of children aged 6 - 60 months. The objective of this study is to determine the prevalence and map out the burden of SCT and SCD in Uganda.",[269],"2026-06-15",{"date":390,"type":35},{"date":414,"type":35},"2013-09-07",{"date":416,"type":21},"2032-12-31",{"name":41,"class":42},4,{"id":420,"slug":4,"hasResults":11,"nctId":421,"briefTitle":422,"officialTitle":423,"acronym":4,"eligibilityCriteria":424,"healthyVolunteers":11,"sex":18,"minAge":4,"maxAge":425,"enrollmentInfo":426,"targetDuration":4,"studyType":22,"phases":428,"briefSummary":430,"conditions":431,"keywords":433,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":411,"lastUpdatePostDateStruct":435,"startDateStruct":436,"completionDateStruct":438,"leadSponsor":440,"locationsCount":441},"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":427,"type":21},1120,[429,187],"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.",[432],"HIV Infection",[434],"HIV Remission",{"date":324,"type":35},{"date":437,"type":35},"2015-01-23",{"date":439,"type":21},"2031-12-31",{"name":199,"class":200},46,{"id":443,"slug":4,"hasResults":11,"nctId":444,"briefTitle":445,"officialTitle":445,"acronym":4,"eligibilityCriteria":446,"healthyVolunteers":11,"sex":18,"minAge":51,"maxAge":4,"enrollmentInfo":447,"targetDuration":4,"studyType":156,"phases":4,"briefSummary":449,"conditions":450,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":452,"lastUpdatePostDateStruct":453,"startDateStruct":454,"completionDateStruct":456,"leadSponsor":458,"locationsCount":459},"100598277","NCT07069400","An International Observational Study of Adults With Acute Infection","Inclusion Criteria:\n\n* Age ≥18 years old\n* Admitted to hospital (or in an emergency department with anticipated hospital admission) for the management of a suspected or confirmed acute infectious disease.\n* Onset of symptoms of an infectious disease within the past 30 days.\n* Informed consent for study participation by the participant or a surrogate decision maker if the participant lacks capacity for consent.\n\nExclusion Criteria:\n\n* Current imprisonment (this does not include quarantine for an infectious disease).\n* Patient undergoing comfort care measures only such that treatment focuses on end- of-life symptom management over prolongation of life.\n* Expected inability or unwillingness to participate in study procedures.\n* In the opinion of the investigator, participation in the study is not in the best interest of the patient.",{"count":448,"type":21},1500,"Prospective, longitudinal studies of people with acute infections are essential to understand risk factors, clinical manifestations, pathobiology, and management strategies. Observational studies can provide data necessary to select interventions and strategies for testing in clinical trials and to develop key design features of trials. Observational studies can be particularly important for establishing an early knowledge base after emergence of a new pathogen, as illustrated by the recent emergence of influenza A (H1N1), SARS-CoV-2, and Mpox. This observational study protocol describes collection of data and biospecimens from sites across the world for characterizing acute infections in hospitalized patients. The protocol is designed to study respiratory infections, infections outside the respiratory tract, established infectious diseases, and emerging infectious diseases. Data generated in this study will be used to efficiently characterize acute infectious diseases and plan future clinical trials.",[451],"Infectious Disease","2026-06-12",{"date":411,"type":35},{"date":455,"type":35},"2025-08-25",{"date":457,"type":21},"2027-06-08",{"name":331,"class":42},50,{"id":461,"slug":4,"hasResults":11,"nctId":462,"briefTitle":463,"officialTitle":464,"acronym":4,"eligibilityCriteria":465,"healthyVolunteers":11,"sex":18,"minAge":51,"maxAge":466,"enrollmentInfo":467,"targetDuration":4,"studyType":22,"phases":469,"briefSummary":470,"conditions":471,"keywords":474,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":452,"lastUpdatePostDateStruct":476,"startDateStruct":477,"completionDateStruct":479,"leadSponsor":481,"locationsCount":482},"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":468,"type":21},186,[187],"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.",[472,473,302],"Major Depressive Disorder","Mild Neurocognitive Disorder",[475],"Comorbid MND",{"date":411,"type":35},{"date":478,"type":35},"2026-05-17",{"date":480,"type":21},"2026-12-02",{"name":199,"class":200},41,{"id":484,"slug":4,"hasResults":11,"nctId":485,"briefTitle":486,"officialTitle":487,"acronym":4,"eligibilityCriteria":488,"healthyVolunteers":11,"sex":18,"minAge":489,"maxAge":4,"enrollmentInfo":490,"targetDuration":4,"studyType":22,"phases":492,"briefSummary":493,"conditions":494,"keywords":496,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":505,"lastUpdatePostDateStruct":506,"startDateStruct":507,"completionDateStruct":509,"leadSponsor":511,"locationsCount":201},"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":491,"type":21},900,[187],"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.",[495],"Tuberculosis",[495,497,498,499,500,501,502,503,504],"Pulmonary tuberculosis","Drug-susceptible tuberculosis","Rifampin-susceptible tuberculosis","Rifapentine","Moxifloxacin","HIV coinfection","Treatment shortening","Risk-stratified treatment","2026-06-11",{"date":411,"type":35},{"date":508,"type":21},"2026-07-31",{"date":510,"type":21},"2029-10-22",{"name":199,"class":200},{"id":513,"slug":4,"hasResults":11,"nctId":514,"briefTitle":515,"officialTitle":516,"acronym":4,"eligibilityCriteria":517,"healthyVolunteers":11,"sex":18,"minAge":4,"maxAge":489,"enrollmentInfo":518,"targetDuration":4,"studyType":22,"phases":520,"briefSummary":521,"conditions":522,"keywords":523,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":505,"lastUpdatePostDateStruct":525,"startDateStruct":526,"completionDateStruct":528,"leadSponsor":530,"locationsCount":531},"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":519,"type":21},144,[429,187],"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.",[495],[302,495,524],"Latent Tuberculosis",{"date":452,"type":35},{"date":527,"type":21},"2026-07-15",{"date":529,"type":21},"2028-05-31",{"name":199,"class":200},11,{"id":533,"slug":4,"hasResults":11,"nctId":534,"briefTitle":535,"officialTitle":536,"acronym":4,"eligibilityCriteria":537,"healthyVolunteers":11,"sex":18,"minAge":238,"maxAge":105,"enrollmentInfo":538,"targetDuration":4,"studyType":156,"phases":4,"briefSummary":540,"conditions":541,"keywords":543,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":550,"lastUpdatePostDateStruct":551,"startDateStruct":552,"completionDateStruct":554,"leadSponsor":556,"locationsCount":558},"100642528","NCT07629154","Smart Discharges for Older Children","Smart Discharges for Older Children: A Cohort Study to Develop Prognostic Algorithms for Post-discharge Readmission and Mortality Among Children Over 5 Years of Age","Inclusion Criteria:\n\n* Age between 0 and 16 years admitted to pediatric ward of hospital for proven or suspected infection\n* Provide informed consent\n* Ability to provide contact information (phone number or address) for phone or in-person follow-up\n\nExclusion Criteria:\n\n* Child lives outside of the catchment area of a study site\n* Admitted for elective procedures, trauma, or short-term observation\n* Language barriers",{"count":539,"type":21},4000,"This study is an observational multi-country cohort study that aims to build algorithms that can identify children between 5 and 16 years of age admitted for proven or suspected sepsis who are at risk of mortality after they are discharged in East Africa.\n\nIn low- and middle-income countries, about 5% of children discharged after hospitalization for sepsis will die in the weeks after returning home. Doctors and parents are often unaware of this period of vulnerability and are poorly equipped to identify or handle this critical situation. This project builds on past work that developed and evaluated models and the Smart Discharges program to predict, during hospitalization, an individual child's risk of recurrent illness and mortality, as well as to provide additional post-discharge support to at-risk children.\n\nParticipants will be enrolled from facilities once they are admitted, collecting clinical and social variables. They will then be followed until 6 months post-discharge to understand what happens to them after they return home. This data will be evaluated to identify which variables collected at facilities can be predictive of mortality and recurrent illness after discharge.",[542],"Sepsis",[544,545,546,547,548,549],"pediatrics","sepsis","risk-prediction","critical care","post-discharge","patient discharge","2026-06-10",{"date":411,"type":35},{"date":553,"type":35},"2024-01-02",{"date":555,"type":21},"2027-04",{"name":557,"class":42},"University of British Columbia",7,{"id":560,"slug":4,"hasResults":11,"nctId":561,"briefTitle":562,"officialTitle":563,"acronym":4,"eligibilityCriteria":564,"healthyVolunteers":11,"sex":18,"minAge":565,"maxAge":4,"enrollmentInfo":566,"targetDuration":4,"studyType":22,"phases":568,"briefSummary":570,"conditions":571,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":573,"lastUpdatePostDateStruct":574,"startDateStruct":575,"completionDateStruct":577,"leadSponsor":579,"locationsCount":581},"100541989","NCT06337032","A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments","An Open-label, Single-arm Study to Provide Continued Access to Study Drug to Participants Who Have Completed Pediatric Clinical Studies Involving Gilead HIV Treatments","Key Inclusion Criteria:\n\n* Completed an applicable parent study: GS-US-292-0106, GS-US-380-1474, GS-US-311-1269, or GS-US-216-0128, and gave consent to study participation.\n\nKey Exclusion Criteria:\n\n* Individuals planning to switch to B\u002FF\u002FTAF on Day 1 with plasma HIV RNA ≥ 50 copies\u002FmL during the last parent study visit prior to screening\u002FDay 1 visit.\n\n  * Note: individuals planning to switch after Day 1 must not have plasma HIV RNA ≥ 50 copies\u002FmL (or detectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies\u002FmL).\n* Individuals planning to switch to B\u002FF\u002FTAF with any ongoing Grade 3 or 4 drug-related AE or clinically relevant Grade 3 or 4 drug-related laboratory abnormality (confirmed on repeat) related to any component of B\u002FF\u002FTAF prior to treatment switch.\n* For those on B\u002FF\u002FTAF or planning to switch to B\u002FF\u002FTAF: previous treatment discontinuation of any component of B\u002FF\u002FTAF due to toxicity or intolerance.\n* For those planning to switch to B\u002FF\u002FTAF: known hypersensitivity to any component of the study drug, its metabolites, or formulation excipients.\n* Ongoing treatment with or prior use of any prohibited medications.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.","1 Month",{"count":567,"type":21},350,[569],"PHASE4","The goal of this clinical study is to provide continued access to the study drug(s) to children and adolescents with human immunodeficiency virus type 1 (HIV-1) who completed their participation in an applicable parent study and to monitor for adverse events.\n\nThe primary objectives of this study are as follows:\n\n* To provide continued access to the study drug received in the parent protocol or switch to bictegravir\u002Femtricitabine\u002Ftenofovir (B\u002FF\u002FTAF) for participants who completed a Gilead parent study evaluating drugs for HIV treatment.\n* To evaluate the safety of the study drug(s) in participants with HIV-1.",[572],"HIV-1-infection","2026-06-09",{"date":550,"type":35},{"date":576,"type":35},"2024-08-27",{"date":578,"type":21},"2034-03",{"name":580,"class":123},"Gilead Sciences",15,{"id":583,"slug":4,"hasResults":11,"nctId":584,"briefTitle":585,"officialTitle":586,"acronym":4,"eligibilityCriteria":587,"healthyVolunteers":11,"sex":18,"minAge":588,"maxAge":51,"enrollmentInfo":589,"targetDuration":4,"studyType":22,"phases":590,"briefSummary":591,"conditions":592,"keywords":594,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":598,"lastUpdatePostDateStruct":599,"startDateStruct":601,"completionDateStruct":603,"leadSponsor":605,"locationsCount":531},"100236290","NCT02354014","Pharmacokinetic Study to Evaluate Anti-mycobacterial Activity of TMC207 in Combination With Background Regimen (BR) of Multidrug Resistant Tuberculosis (MDR-TB) Medications for Treatment of Children\u002FAdolescents With Pulmonary MDR-TB","A Phase 2, Open-label, Multicenter, Single-arm Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Anti-mycobacterial Activity of TMC207 in Combination With a Background Regimen (BR) of Multidrug Resistant Tuberculosis (MDR-TB) Medications for the Treatment of Children and Adolescents 0 Months to \u003C18 Years of Age Who Have Confirmed or Probable Pulmonary MDR-TB","Inclusion Criteria:\n\n* Participant must be a boy or girl, aged from birth (0 months) to less than (\\\u003C) 18 years at screening. Participants in Cohort 4 who are \\\u003C6 months of age at screening, gestational age at birth had to be greater than or equal to (\\>=) 37 weeks\n* Participant must weigh \\>3 kilogram (kg) at baseline and be within the 5th and 95th percentiles (inclusive) for the participant's age, based on the World Health Organization (WHO) child growth standards; Body Mass Index (BMI) for age. In Cohorts 3 and 4, weight for height\u002Flength may be used instead of BMI for age according to the local standard of care. Per WHO guidance, for participants aged \\\u003C 2 years in Cohort 4, length will be used to calculate the BMI instead of height\n* For Cohorts 1 and 2 only: Heterosexually active girls may participate if they are of non-childbearing potential, or if they are using effective birth control methods and are willing to continue practicing birth control methods throughout Multidrug Resistant Tuberculosis (MDR-TB) treatment and for 6 months after stopping TMC207 treatment, or if they are non-heterosexually active or willing to practice sexual abstinence throughout MDR-TB treatment\n* For Cohorts 1 and 2 only: Boys who engage in sexual activity that could lead to pregnancy of the female partner must use at minimum a male condom throughout MDR-TB treatment and for 3 months after stopping TMC207 treatment\n* Participant must have confirmed or probable (clinically diagnosed or presumed) pulmonary and\u002For non-severe extrapulmonary MDR-TB, including pre-extensively drug-resistant TB (pre- extensively drug resistant \\[XDR\\]-TB) or XDR-TB infection, based on the case definitions of pediatric pulmonary and non-severe extrapulmonary TB as described in the International (WHO) guidelines and in accordance with the local standard of care\n* Participants must be starting the initial MDR-TB treatment at Day 1 or have started an MDR-TB treatment within 12 weeks of Day 1 and are willing to modify it if necessary to an acceptable MDR-TB regimen for use with TMC207\n* Participant must be willing to permanently discontinue RMP from at least 7 days before the baseline visit\n* Participant or legally acceptable representative must consent\u002Fassent to human Immunodeficiency virus (HIV) testing of the participant. The mother must also consent to testing of her own HIV status, if the potential participant is a child aged \\\u003C2 years, or if the participant is \\>= 2 years old and being breastfed or was breastfed within the last 8 weeks before screening, unless the mother had HIV test performed within 1 month prior to screening and documentation of HIV status can be provided. When documented HIV-positive status is available prior to screening for participants in Cohort 4 or their mother, HIV testing for the participant and mother is not required\n\nExclusion Criteria:\n\n* Participant has a clinically significant active medical condition or the presence of any concomitant severe illness or rapidly deteriorating health condition, including immune deficiency (except HIV infection), which in the opinion of the investigator would prevent appropriate participation in the study, or that would make implementation of the protocol or interpretation of the study results difficult, or otherwise make the subject a poor candidate for a clinical study\n* Participant is a girl who is pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 6 months after stopping TMC207 treatment\n* Participant has known or presumed forms of extrapulmonary TB, other than: Lymphadenopathy (peripheral nodes or isolated mediastinal mass without significant airway compression); Pleural effusion or pleural fibrotic lesions\n* Participant has a significant cardiac arrhythmia that requires medication or risk factors for Torsade de Pointes, example heart failure, hypokalemia, known personal or family history of Long QT Syndrome, and untreated hypothyroidism","0 Months",{"count":340,"type":21},[187],"The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (explores what the body does to the drug), and anti-mycobacterial activity of bedaquiline (TMC207) in children and adolescents (0 months to less than \\[\\\u003C\\] 18 years of age) diagnosed with confirmed or probable pulmonary multidrug resistant tuberculosis (MDR-TB), in combination With a Background Regimen (BR) of MDR-TB Medications.",[593],"Tuberculosis, Multidrug-Resistant",[595,596,597],"Multidrug-Resistant Tuberculosis","Bedaquiline","TMC207","2026-06-04",{"date":600,"type":35},"2026-06-05",{"date":602,"type":35},"2016-05-03",{"date":604,"type":21},"2028-11-02",{"name":606,"class":123},"Janssen Research & Development, LLC",{"id":608,"slug":4,"hasResults":11,"nctId":609,"briefTitle":610,"officialTitle":611,"acronym":612,"eligibilityCriteria":613,"healthyVolunteers":11,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":614,"targetDuration":4,"studyType":22,"phases":616,"briefSummary":617,"conditions":618,"keywords":620,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":621,"lastUpdatePostDateStruct":622,"startDateStruct":624,"completionDateStruct":626,"leadSponsor":628,"locationsCount":630},"100559772","NCT06568484","Bedaquiline Roll-out Evidence in Contacts and People Living With HIV to Prevent TB","Bedaquiline Roll-out Evidence in Contacts and People Living With HIV to Prevent TB (BREACH-TB)","BREACH-TB","INCLUSION CRITERIA\n\nFor Index Patient\n\n• Any age\n\n* A diagnosis of bacteriologically proven pulmonary TB\n* Initiated on treatment for pulmonary TB within the past 90 days\n* Have at least one close contact that is likely to be eligible for the study\n\nFor PLHIV Indication\n\nIndividuals must meet all of the following inclusion criteria to participate in this study:\n\n* On a dolutegravir-based or other approved integrase inhibitor antiretroviral therapy (ART) regimen that does not interact with bedaquiline or rifapentine.\n\n  * If on a protease inhibitor-based ART regimen, a participant can be enrolled following a 5-day washout with switch to a dolutegravir-based regimen prior to enrollment. A 14-day washout is required for efavirenz-based ART regimen with switch to a dolutegravir-based regimen prior to enrollment\n  * If a participant is not currently on ART or is ART-naïve, the participant must have started a dolutegravir-based ART regimen prior to Enrollment.\n* PLHIV who meet criteria for a TBD close contact should be enrolled under the close contact indication\n\nFor Close Contact Indication (DS- or RR-TB Index Patient)\n\n* Definition of Close Contact (either\u002For):\n\n  o Lives or lived in the same dwelling unit or plot of land and shares or has shared the same housekeeping arrangements as the Index Patient for one or more nights ≤ 90 days prior to the Index Patient starting TB treatment\n\n  o Has shared more than four hours of indoor airspace with the Index Patient during any one-week period ≤ 90 days prior to the Index Patient starting TB treatment. This may include indoor airspace within or outside the home.\n* Close contacts must be in one of the following high-risk groups:\n\n  * All children 0 to \\\u003C5 years old at the time of Enrollment, regardless of LTBI or HIV status\n  * Adults, adolescents, and children ≥5 years of age who are TBI test positive (either skin test positive\\* or IGRA-positive) and whose HIV status is negative, indeterminate, or unknown.\n  * Adults, adolescents, and children ≥5 years of age who have a documented HIV infection regardless of TBI test status.\n\nUniversal Enrollment Inclusion Criteria for PLHIV and Close Contacts of DS- or RR-TB Index Patient\n\nA. Ability and willingness of participant (and\u002For parent\u002Fguardian) to provide informed consent (and assent, as applicable)\n\nB. Documentation of HIV Status\n\nFor participants \\>=18 months of age known to be PLHIV:\n\n* Certified copy of HIV clinic card or\n* Certified copy of HIV testing that includes date, assay used and result\n\nFor participants \\\u003C18 months of age who have never tested, or previous HIV test result was indeterminate, unknown, or negative more than three months prior to screening and\u002For result is not available:\n\n• HIV-1 testing should be performed per Section 5.4.5 (HIV-1 Testing) during the study screen period.\n\nFor participants \\\u003C18 months known to be CLHIV:\n\n• Certified copies of HIV DNA and\u002For RNA testing that includes date, assay used, and result\n\nFor participants \\\u003C18 months who have never tested, or previous HIV test result was indeterminate, unknown, or negative more than three months prior to screening and\u002For result is not available:\n\n• HIV-1 testing should be performed per Section 5.4.5 (HIV-1 Testing) during the study screen period\n\nC. Documentation of ART\n\n* All PLHIV (for PLHIV indication and CC that are PLHIV) must be on a dolutegravir-based or other approved integrase inhibitor ART regimen that does not interact with bedaquiline or rifapentine.\n* If on a protease inhibitor-based ART regimen, a participant can be enrolled following a 5-day washout with switch to a dolutegravir-based regimen prior to enrollment. A 14-day washout is required for efavirenz-based ART regimen with switch to a dolutegravir-based regimen prior to enrollment.\n* If a participant is not currently on ART or is ART-naïve, they must have started a dolutegravir-based ART regimen prior to Enrollment.\n\nD. Chest radiograph without evidence of active TBD, performed within 30 days prior to Enrollment\n\nE. The following laboratory values obtained within 30 days prior to Enrollment.\n\n* Alanine aminotransferase (ALT) ≤ 3 times the upper limit of normal\n* Total bilirubin ≤ 2.5 times the upper limit of normal\n* Alkaline phosphatase ≤ 3 times the upper limit of normal\n* Creatinine clearance ≥ 29 ml\u002Fmin\n* Serum potassium at or above the lower limit of normal\n* Serum magnesium at or above the lower limit of normal\n* Serum calcium at or above the lower limit of normal\n* Platelet count of ≥ 50,000 \u002Fmm3\n* Absolute neutrophil count (ANC) ≥ 1,000\u002Fmm3\n\nF. Pregnancy test (for study candidates of childbearing potential\\*)\n\n• Negative serum or urine pregnancy test within 7 days prior to enrollment.\n\n\\*NOTE: Participants of childbearing potential are defined as females who have reached menarche or who have not been post-menopausal for at least 24 consecutive months (i.e., who have had menses within the preceding 24 months) or have not undergone surgical sterilization (e.g., hysterectomy, bilateral oophorectomy, or bilateral tubal ligation).\n\nEXCLUSION CRITERIA\n\nExclusion Criteria for Index Patient A. Unwilling or unable to provide informed consent B. No close contacts likely to be eligible for the study C. Study staff unable to obtain status of TB drug susceptibility or resistance D. Known bedaquiline resistance of M. tb isolate E. Known fluoroquinolone resistance of M. tb isolate (for Index Patients with RR-TB)\n\nExclusion Criteria for PLHIV and Close Contacts of DS- or RR-TB Index Patient\n\nA. Unwilling or unable to provide informed consent\n\nB. Weight ≤ 3 kg\n\nC. A current diagnosis of confirmed or probable or possible pulmonary or extrapulmonary TB at time of enrollment or confirmed or unconfirmed TB for children.\n\nD. Previously completed treatment for TBD.\n\nE. Prior completion of TPT (including but not limited to 6 or 9H, 1HP, 3HP, 4R, 3HR, 6Lfx) \\*\n\n\\*NOTE: Completion of TBD treatment or TPT based on the opinion of the site investigator that a sufficient course of TPT was taken to constitute treatment completion\n\nF. Current enrollment into another therapeutic clinical trial (See Section 5.8).\n\nG. Any of the following medical conditions:\n\n* Severe renal impairment (DAIDS Grade 4) or end-stage renal disease requiring hemodialysis or peritoneal dialysis\n* Severe hepatic impairment (Child-Pugh C)\n* Evidence of acute hepatitis, such as abdominal pain, jaundice, dark urine, and\u002For light stools within 90 days prior to enrollment\n* Severe cardiac arrythmia requiring medication\n* Peripheral neuropathy ≥ Grade 2 (DAIDS)\n* Diagnosis of porphyria at any time prior to study enrollment\n* Corrected QTcF (Fridericia's formula) of \\>460 msec\n* Unable to take oral medication\n* Active drug or alcohol use or dependence that, in the site investigator's opinion, would interfere with adherence to study treatment.\n* Serious illness requiring systemic treatment including parenteral therapy (e.g., antibiotics) and\u002For hospitalization within 30 days prior to Enrollment\n* Prior exposure to bedaquiline or clofazimine\n* Receipt of more than 7 cumulative days of isoniazid, a rifamycin, or a fluoroquinolone in the 90 days prior to enrollment\n* Known bedaquiline resistance in Index Patient\n* Known allergy\u002Fsensitivity or any hypersensitivity to components of study drugs or their formulation\n* Currently taking another medication that is prohibited with study medicines which cannot be stopped (with or without replacement) or requires a washout period longer than 14 days (See Appendix 7)\n* Known pregnancy or breastfeeding\n\nSpecific Exclusion Criteria for Close Contacts of RR-TB Index Patient\n\n* Known fluoroquinolone resistance in Index Patient\n* Severe tendinopathy related to fluoroquinolones",{"count":615,"type":21},2530,[187,110],"A seamless, staged Phase II\u002FIII, open-label, multicenter, non-inferiority trial, to compare the efficacy and safety of 4 weeks of bedaquiline (BDQ) versus a a standard regimen for preventing regimen for preventing confirmed or probable tuberculosis disease (TBD) during 72 weeks of follow-up among people living with HIV (PLHIV) and high-risk Close Contacts (CC) of adults with Drug Susceptible (DS) or Rifampin Resistant (RR) TB.",[619],"Tuberculosis, Latent",[596],"2026-06-01",{"date":623,"type":35},"2026-06-03",{"date":625,"type":35},"2026-05-08",{"date":627,"type":21},"2027-09",{"name":629,"class":42},"Johns Hopkins University",6,""]