[{"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:":678},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,117,0,25,[9,44,69,92,122,160,192,225,247,267,290,315,344,368,390,417,450,473,495,516,549,583,604,625,648],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100598448","phase-3-a-study-of-mk-8527-to-prevent-human-immunodeficiency-virus-type-1-hiv-1-mk-8527-010-100598448",false,"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",true,"FEMALE","16 Years","30 Years",{"count":22,"type":23},4580,"ESTIMATED","INTERVENTIONAL",[26],"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",[29,30],"Human Immunodeficiency Virus (HIV)","HIV Pre-Exposure Prophylaxis","RECRUITING","2026-08-21",{"date":34,"type":35},"2026-08-24","ACTUAL",{"date":37,"type":35},"2025-11-10",{"date":39,"type":23},"2027-10-18",{"name":41,"class":42},"Merck Sharp & Dohme LLC","INDUSTRY",30,{"id":45,"slug":46,"hasResults":12,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":12,"sex":52,"minAge":53,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":24,"phases":56,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":68},"100507964","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-inavolisib-in-combination-with-phesgo-versus-placebo-in-combination-with-phesgo-in-participants-with-pik3ca-mutated-her2-positive-locally-advanced-or-metastatic-breast-cancer-100507964","NCT05894239","A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer","A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo As Maintenance Therapy After First Line Induction Therapy in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer","INAVO122","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1\n* Histologically or cytologically confirmed and documented adenocarcinoma of the breast with metastatic or locally advanced disease not amenable to curative resection\n* Confirmation of HER2 biomarker eligibility based on valid results from central testing of tumor tissue documenting HER2-positivity\n* Confirmation of PIK3CA-mutation biomarker eligibility based on valid results from central testing of tumor tissue documenting PIK3CA-mutated tumor status\n* Disease-free interval from completion of adjuvant or neoadjuvant systemic non-hormonal treatment to recurrence of \\>= 6 months\n* LVEF (left ventricular ejection fraction) of at least 50% measured by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA)\n* Adequate hematologic and organ function prior to initiation of study treatment\n\nExclusion Criteria:\n\n* Prior treatment in the locally advanced or metastatic setting with any PI3K, AKT, or mTOR inhibitor or any agent whose mechanism of action is to inhibit the PI3K-AKT-mTOR pathway\n* Any prior systemic non-hormonal anti-cancer therapy for locally advanced or metastatic HER2-positive breast cancer prior to initiation of induction therapy\n* History or active inflammatory bowel disease\n* Disease progression within 6 months of receiving any HER2-targeted therapy\n* Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes\n* Participants with active HBV infection\n* Clinically significant and active liver disease, including severe liver impairment, viral or other hepatitis, current alcohol abuse, or cirrhosis\n* Symptomatic active lung disease, including pneumonitis or interstitial lung disease\n* Any history of leptomeningeal disease or carcinomatous meningitis\n* Serious infection requiring IV antibiotics within 7 days prior to Day 1 of Cycle 1\n* Any concurrent ocular or intraocular condition that, in the opinion of the investigator, would require medical or surgical intervention during the study period to prevent or treat vision loss that might result from that condition\n* Active inflammatory or infectious conditions in either eye or history of idiopathic or autoimmune-associated uveitis in either eye","ALL","18 Years",{"count":55,"type":23},230,[26],"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).",[59],"Metastatic Breast Cancer",{"date":61,"type":35},"2026-08-25",{"date":63,"type":35},"2023-09-08",{"date":65,"type":23},"2032-12-28",{"name":67,"class":42},"Hoffmann-La Roche",192,{"id":70,"slug":71,"hasResults":12,"nctId":72,"briefTitle":73,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":12,"sex":52,"minAge":4,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":24,"phases":77,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":91},"100477415","meningitis-burden-causes-screening-and-prevention-in-rural-northern-uganda-100477415","NCT05496673","Meningitis: Burden, Causes, Screening and Prevention in Rural Northern Uganda","Inclusion Criteria:\n\n* 1100 patients who present with meningitis or meningitis symptoms, regardless of age or vulnerably status are eligible for meningitis testing.\n* 10,000 HIV-infected patients presenting to LRRH, LRRH HIV Clinic (LIDC) or nearby outpatient clinics, regardless of age or vulnerability status, are eligible for CrAg screening.\n\nExclusion Criteria:\n\n* Patients who are found not to have meningitis after initial evaluation, or are found to have other alternative diagnoses that explain their symptoms, will be excluded.\n* HIV-negative patients without signs or symptoms of meningitis.",{"count":76,"type":23},11100,[78],"NA","This study will investigate the burden, causes, diagnostics, treatments and preventive measures related to meningitis in northern Uganda. We hypothesize that understanding the burden of meningitis, risk factors, diagnostics, treatments and the preventive measures will provide information regarding the gaps in care that can be addressed in order to improve the continuum of meningitis care. we hypothesize that our data will support the advocacy for the implementation of routine vaccination for the prevention of bacterial meningitis and improving guidelines for Cryptococcal antigen (CrAg) screening for prevention of cryptococcal meningitis, which will save lives in Uganda.\n\nAim 1: To prospectively collect data on 1100 patients with meningitis and meningitis symptoms who were admitted to Lira Regional Referral Hospital (LRRH) to assess burden, etiologies, pathogenesis, and outcomes of meningitis using modern diagnostic testing not previously available in Uganda.\n\nAim 2: To perform CrAg screening of 10,000 HIV-positive patients to determine the prevalence of cryptococcal antigenemia (infection) and conduct a case control study to compare risk factors and outcomes among CrAg-positive patients and matched CrAg-negative controls based on age, sex, TB status, ART experience, CD4 count, and viral load.",[81],"Meningitis","2026-08-19",{"date":32,"type":35},{"date":85,"type":35},"2022-09-01",{"date":87,"type":23},"2031-09-01",{"name":89,"class":90},"University of Rochester","OTHER",1,{"id":93,"slug":94,"hasResults":12,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":12,"sex":52,"minAge":53,"maxAge":4,"enrollmentInfo":100,"targetDuration":4,"studyType":24,"phases":102,"briefSummary":103,"conditions":104,"keywords":106,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":121},"100633329","trial-phase-syndemic-adapted-medly-uganda-100633329","NCT07525271","Trial Phase: Syndemic Adapted Medly Uganda","An mHealth Implementation Strategy to Address the Syndemic of Mental Illness, Hypertension, and HIV in Uganda, Clinical Trial: Syndemic Adapted Medly Uganda (SAMU)","SAMU","Inclusion Criteria:\n\n* Patient at a participating HIV clinic site\n* Currently living in Uganda with no intention of moving abroad in next 2 years\n* Access to a mobile phone\n* Basic reading skills in one or more of the offered languages (English, Luganda) as determined by the Research Assistant.\n\nExclusion Criteria:\n\n* No access to a mobile phone\n* Inability to provide informed consent based on assessment by the onsite Research Assistant or HCW\n\nHealthcare Workers\u002FCaregivers Criteria:\n\n* Age \\>=18 years\n* Healthcare worker at participating site or caregiver for study participant at site\n* Basic reading skills in one or more of the offered languages (English, Luganda) as determined by the Research Assistant",{"count":101,"type":23},1500,[78],"The purpose of this study is to evaluate the effectiveness of the Syndemic-Adapted Medly Uganda (SAMU) in improving mental health care among adults living with HIV and hypertension in Uganda. In sub-Saharan Africa (SSA), there is a high prevalence of depression and anxiety among people living with HIV (PLHIV) as well as alcohol use disorder (AUD). PLHIV who experience depression are less likely to link to HIV care, adhere to antiretroviral therapy, and achieve viral suppression. Building on research conducted to adapt Medly Uganda for mental health using a syndemic framework, this study aims to assess the effectiveness of SAMU on mental health screening and diagnosis. This will be accomplished through a two-arm trial in which 1. participants will be enrolled, screened, re-screened, and assessed for diagnosis and linkage to care for depression, anxiety and AUD and 2. evaluate the factors impacting sustained engagement in the SAMU program, through mixed methods.",[105],"Mental Health",[107,108,109,110,111],"Depression","Anxiety","HIV","Alcohol Use Disorder","hypertension","NOT_YET_RECRUITING","2026-08-18",{"date":82,"type":35},{"date":116,"type":23},"2026-09",{"date":118,"type":23},"2028-06",{"name":120,"class":90},"Yale University",3,{"id":123,"slug":124,"hasResults":12,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":128,"eligibilityCriteria":129,"healthyVolunteers":12,"sex":52,"minAge":130,"maxAge":131,"enrollmentInfo":132,"targetDuration":4,"studyType":24,"phases":134,"briefSummary":135,"conditions":136,"keywords":138,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":152,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":159},"100549825","phase-3-a-study-to-investigate-the-efficacy-and-safety-of-crizanlizumab-5-mgkg-compared-with-placebo-in-adolescent-and-adult-sickle-cell-disease-patients-who-experience-frequent-vaso-occlusive-crises-sparkle-100549825","NCT06439082","A Study to Investigate the Efficacy and Safety of Crizanlizumab (5 mg\u002Fkg) Compared With Placebo in Adolescent and Adult Sickle Cell Disease Patients Who Experience Frequent Vaso-Occlusive Crises (SPARKLE)","A Phase III, Multicenter, Randomized, Placebo Controlled, Double-blind Study to Assess Efficacy and Safety of Crizanlizumab (5 mg\u002Fkg) Versus Placebo, With or Without Hydroxyurea\u002FHydroxycarbamide Therapy, in Adolescent and Adult Sickle Cell Disease Patients With Frequent Vaso-Occlusive Crises","SPARKLE","Key Inclusion Criteria:\n\n1. Participants must be aged 12 years and older on the day of signing informed consent. Adolescents include participants aged 12 to \\\u003C18 years old and adults include participants aged 18 years and older.\n2. Confirmed diagnosis of SCD by Hb electrophoresis or high-performance liquid chromatography (HPLC) (performed locally or by central laboratory if not available locally). All SCD genotypes are eligible.\n3. Experienced 4 to 12 VOCs (refer to Section 8.3.1 for study definition of VOC) that are HCP-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) within the 12 months prior to the screening visit. Baseline VOCs are determined by medical history and are required to be documented at source.\n4. If the participant is on HU\u002FHC, they must be taking it for at least 6 months and at stable dose for at least 3 months prior to the Screening visit and plan to continue taking it at the same dose and schedule until at least the participant has reached 52 weeks of the planned study treatment. Participants who have initiated HU\u002FHC 6-12 months prior to the screening visit must have evidence of insufficient control of acute pain despite initiation. These participants must have a cumulative of 4-12 VOCs in the 12 months prior to the screening period, with at least 2 during the last 6 months while on HU\u002FHC. If receiving erythropoietin stimulating agent, the participant must have been receiving the drug for at least 6 months prior to screening visit and plan to continue taking the drug at the same dose and schedule until the participant has reached 52 weeks of the planned study treatment.\n\nParticipants who have not been receiving HU\u002FHC, and\u002For erythropoietin stimulating agent must not have received it for at least 6 months prior to screening visit.\n\nKey Exclusion Criteria:\n\n1. Fewer than 4 or more than 12 VOCs that are HCP-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) within the 12 months prior to screening visit as determined by medical history and documented at source.\n2. History of stem cell transplant and\u002For gene therapy.\n3. Received blood products within 30 days prior to Week 1 Day 1 dosing.\n4. Any documented history of a clinical stroke or intracranial hemorrhage, or an uninvestigated neurologic finding within the past 12 months before screening visit. Silent infarct only present on imaging is not excluded.\n5. Participating in a chronic transfusion program (pre-planned series of transfusions for prophylactic purposes) and\u002For planning to undergo an exchange transfusion during the duration of the study; episodic transfusion in response to worsened anemia or VOC is permitted.\n6. Contraindication or hypersensitivity to any drug or metabolites from similar class as study drug or to any excipients of the study drug formulation. History of severe hypersensitivity reaction to other monoclonal antibodies, which in the opinion of the investigator may pose an increased risk of serious infusion reaction.","12 Years","100 Years",{"count":133,"type":23},354,[26],"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.",[137],"Sickle Cell Disease",[137,139,140,141,142,143,144,145,146,147,148,149,150,151],"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":82,"type":35},{"date":154,"type":35},"2024-10-24",{"date":156,"type":23},"2030-07-29",{"name":158,"class":42},"Novartis Pharmaceuticals",34,{"id":161,"slug":162,"hasResults":12,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":166,"eligibilityCriteria":167,"healthyVolunteers":12,"sex":52,"minAge":168,"maxAge":4,"enrollmentInfo":169,"targetDuration":4,"studyType":24,"phases":171,"briefSummary":172,"conditions":173,"keywords":178,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":91},"100652434","relaxation-intervention-to-improve-newborn-growth-and-maternal-well-being-100652434","NCT07774793","Relaxation Intervention to Improve Newborn Growth and Maternal Well-being","Randomized Controlled Trial of a Relaxation Intervention to Improve Newborn Growth and Maternal Well-being","RING-MW","Inclusion Criteria:\n\n* Newborn low birth weight (LBW) (birth weight \\\u003C 2500 grams)\n* Newborn birth weight \\>= 1800 g\n* Newborn admitted to Neonatal Intensive Care Unit (NICU)\n* Newborn in stable condition without WHO danger signs\n* Newborn age \\\u003C24 hours old\n* Breastfeeding initiated\n* Residence in the catchment area\n\nExclusion Criteria:\n\n* Twins and other multiples\n* Newborn respiratory support or WHO danger signs\n* Newborn with major congenital anomaly or expected surgery\n* Contraindications to or unable to breastfeed\n* Mother with hearing impairment\n* Unable to speak Luganda","0 Days",{"count":170,"type":23},100,[78],"The goal of this clinical trial is to learn if listening to a relaxation audiorecording during breastfeeding improves breastfeeding and infant outcomes and maternal well-being in a low-income country setting. The main questions it aims to answer are:\n\n* Does listening to a relaxation audiorecording during breastfeeding improve infant growth?\n* Does listening to a relaxation audiorecording during breastfeeding reduce maternal stress and anxiety?\n\nResearchers will compare listening to an audiorecording on a digital recording device to receiving the digital recording device without an audiorecording to see if relaxation audiorecordings work to improve breastfeeding, infant growth and maternal well-being.\n\nParticipants will:\n\n* Listen to an audiorecording twice daily while breastfeeding for 12 weeks\n* Have study visits at 1, 2, 4 and 12 weeks for checkups and tests\n* Let us know what they think of the audiorecording",[174,175,176,177],"Well-Being, Psychological","Breastfeeding","Low Birth Weight","Undernutrition",[179,180,181,182,183],"relaxation","audiorecording","breastfeeding","well-being","maternal-child health","2026-08-17",{"date":82,"type":35},{"date":187,"type":23},"2026-08",{"date":189,"type":23},"2027-05",{"name":191,"class":90},"University of California, San Francisco",{"id":193,"slug":194,"hasResults":12,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":4,"eligibilityCriteria":198,"healthyVolunteers":12,"sex":52,"minAge":199,"maxAge":4,"enrollmentInfo":200,"targetDuration":4,"studyType":24,"phases":202,"briefSummary":204,"conditions":205,"keywords":207,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":216,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":221,"locationsCount":224},"100641915","phase-2-a-trial-of-stratified-patient-centered-treatment-regimens-for-active-tb-spectra-tb-100641915","NCT07595042","A Trial of Stratified Patient-Centered Treatment Regimens for Active TB (SPECTRA-TB)","A Phase 2C Trial of Stratified Patient-Centered Treatment Regimens for Active TB","Inclusion Criteria:\n\n* Has pulmonary tuberculosis (TB) that is likely to respond to standard TB medicines (drug-susceptible TB), based on sputum testing done within 7 days before entering the study. The test must show Mycobacterium tuberculosis is present, with no rifamycin resistance detected and no known resistance to isoniazid or fluoroquinolones.\n* Has a SPECTRA-TB risk score and risk group assigned during screening using the study-specific calculator.\n* Has a Karnofsky performance score of 50 or higher within 30 days before entering the study.\n* Has documented HIV-1 status (either with HIV or without HIV) based on acceptable testing.\n* If living with HIV, has a CD4+ cell count of at least 50 cells\u002Fmm3 within 60 days before study entry.\n* If living with HIV, is currently receiving or plans to start an efavirenz-based or dolutegravir-based antiretroviral therapy regimen by study week 8.\n* Has laboratory test results within 7 days before study entry that meet all of the following:\n\n  * alanine aminotransferase (ALT) no more than 3 times the upper limit of normal\n  * total bilirubin no more than 2.5 times the upper limit of normal\n  * creatinine no more than 2 times the upper limit of normal\n  * potassium between 3.5 and 5.5 mEq\u002FL\n  * absolute neutrophil count at least 1000\u002Fmm3\n  * hemoglobin at least 7.0 g\u002FdL\n  * platelet count at least 100,000\u002Fmm3\n* If able to become pregnant, has a negative blood or urine pregnancy test within 7 days before study entry.\n* If able to become pregnant and sexually active in a way that could lead to pregnancy, agrees not to try to become pregnant and agrees to use at least 1 reliable non-hormonal birth control method during study treatment and for 30 days after stopping study drugs. Acceptable methods include:\n\n  * condoms\n  * intrauterine device (IUD) or intrauterine system (IUS)\n  * cervical cap with spermicide\n  * diaphragm with spermicide\n* If not able to become pregnant, has a history or documentation of menopause, hysterectomy, bilateral removal of the ovaries, or bilateral tubal ligation.\n* Has a verifiable address or place of residence and is willing to tell the study team about any change of address during treatment and follow-up.\n* Is willing and able to give informed consent, or assent with permission from a parent or legal guardian if required.\n\nExclusion Criteria:\n\n* TB bacteria are known to be resistant to 1 or more of the following medicines: rifampin, isoniazid, pyrazinamide, ethambutol, or fluoroquinolones.\n* Received more than 5 days of treatment for active TB within the 24 weeks before study entry.\n* Received more than 5 days of treatment within the 30 days before study entry with certain TB medicines or related antibiotics, including isoniazid, rifampin, rifapentine, ethambutol, moxifloxacin, pyrazinamide, aminoglycosides, fluoroquinolones, linezolid, bedaquiline, pretomanid, and other specified anti-TB drugs.\n* Has suspected or confirmed TB involving the brain or central nervous system, bones, joints, heart lining (pericardium), or miliary TB.\n* Has a past history of suspected or confirmed drug-resistant TB of any type.\n* Is currently pregnant or breastfeeding.\n* Cannot take medicines by mouth.\n* Has an HIV\u002FAIDS-related opportunistic infection at study entry.\n* Has acute or chronic hepatitis B, unless the hepatitis B infection has cleared.\n* Has acute or chronic hepatitis C, unless the hepatitis C infection has cleared or has been successfully treated.\n* Has alcohol-related liver disease.\n* Has liver cirrhosis.\n* Has a history of aortic aneurysm or aortic dissection.\n* Has a known history of long QT syndrome, a first-degree relative with long QT syndrome, or a screening ECG showing QTcF greater than 470 ms that does not correct with treatment of contributing factors.\n* Is taking other medicines that can prolong the QT interval and cannot safely switch to an alternative medicine.\n* Has a known history of acute intermittent porphyria.\n* Weighs less than 30 kg.\n* Is currently using, or is expected to need within 24 weeks after enrollment, 1 or more medicines that are not allowed during the study.\n* Has a known allergy, sensitivity, or hypersensitivity to any of the study drugs or their ingredients.\n* Has active drug or alcohol use, dependence, mental illness, or another serious infection that, in the opinion of the site investigator, could make it hard to follow the study requirements.\n* Is currently taking part in another interventional clinical trial.","13 Years",{"count":201,"type":23},900,[203],"PHASE2","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.",[206],"Tuberculosis",[206,208,209,210,211,212,213,214,215],"Pulmonary tuberculosis","Drug-susceptible tuberculosis","Rifampin-susceptible tuberculosis","Rifapentine","Moxifloxacin","HIV coinfection","Treatment shortening","Risk-stratified treatment",{"date":82,"type":35},{"date":218,"type":23},"2026-10-30",{"date":220,"type":23},"2029-10-22",{"name":222,"class":223},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",29,{"id":226,"slug":227,"hasResults":12,"nctId":228,"briefTitle":229,"officialTitle":230,"acronym":4,"eligibilityCriteria":231,"healthyVolunteers":12,"sex":52,"minAge":4,"maxAge":199,"enrollmentInfo":232,"targetDuration":4,"studyType":24,"phases":234,"briefSummary":236,"conditions":237,"keywords":238,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":240,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":246},"100602518","phase-1-a-study-of-daily-rifapentine-combined-with-isoniazid-1hp-for-tuberculosis-prevention-in-children-less-than-13-years-of-age-with-and-without-hiv-100602518","NCT07124559","A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV","Phase I\u002FII Dose Finding, Safety and Tolerability Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV","Inclusion Criteria:\n\n1. A parent or legal guardian must be willing and able to give written permission for the child to participate in the study. If required by local policies, the child must also be willing and able to give written assent to participate. All sites must follow local policies and procedures.\n2. Age requirements at entry:\n\n   * Cohort 1: Children under 13 years old.\n   * Cohort 2: Children aged 12 weeks to under 13 years old.\n3. For Cohort 1 participants under 28 days old: The child must have been born at or after 37 weeks of pregnancy, as determined by the site investigator using parent\u002Fguardian report or medical records.\n4. Weight requirements at entry:\n\n   * Cohort 1: 3 kg to under 45 kg.\n   * Cohort 2: 6 kg to under 45 kg.\n5. HIV status:\n\n   * Cohort 1: Must be living without HIV.\n   * Cohort 2: Must be living with HIV.\n6. At risk of TB disease, defined as meeting at least one of the following:\n\n   * Having close contact with someone with infectious pulmonary TB within the past six months.\n   * A positive tuberculin skin test (TST) or, for those over two years old, a positive interferon gamma release assay (IGRA) if TST is not available.\n   * For Cohort 2 only: Living in a high TB burden area (≥ 60 TB cases per 100,000 people per year).\n7. Normal or mild (grade 1 or 2) test results for the following at screening (within 21 days before entry):\n\n   * ALT (liver enzyme)\n   * Estimated glomerular filtration rate (kidney function)\n   * Absolute neutrophil count (white blood cells)\n   * Hemoglobin (red blood cells)\n8. For Cohort 2 participants:\n\n   * Must have been on antiretroviral therapy (ART) for at least 12 weeks before entry.\n   * Must have been on a specific ART regimen (once-daily DTG and two NRTIs) for at least 14 days before entry.\n   * Must have used the same formulation of DTG (tablet or dispersible tablet) for at least three days before entry.\n   * Must agree to continue the same formulation of DTG for the study duration.\n   * Must have an HIV-1 RNA level below 200 copies\u002FmL at screening.\n9. Must intend to stay in the same area for the study duration.\n10. Must have access to at least one meal per day during the 28-day treatment period.\n\nExclusion Criteria:\n\n1. The child has active TB, confirmed by medical records, parent\u002Fguardian report, or tests during screening, indicated by:\n\n   * Currently being treated for active TB.\n   * Symptoms like poor growth, poor weight gain, weight loss, cough for at least 11 days, or fever for at least eight days.\n   * X-ray or CT scan showing TB.\n   * Positive TB test results (e.g., culture, Xpert MTB\u002FRIF Ultra, Truenat M.tb, other nucleic acid tests, urine tests).\n2. The child has been exposed to an adult with drug-resistant TB (resistant to Rifampicin or Isoniazid) within the past six months.\n3. The child has taken the following medications:\n\n   * Daily Isoniazid in the 28 days before entry.\n   * Any prohibited medications listed in the study within three days before entry.\n4. The child has any of the following conditions:\n\n   * Acute or chronic hepatitis.\n   * Allergy to Isoniazid or rifamycins.\n   * Porphyria.\n   * Severe peripheral neuropathy.\n5. The child has severe acute malnutrition (weight-for-height\u002Flength less than -3 z-scores of WHO standards). Note: Children who are stunted (height-for-age more than two standard deviations below WHO standards) are eligible.\n6. For Cohort 2: The child has an active AIDS-defining opportunistic infection.\n7. The child has started menstruation.\n8. The child has taken NVP, EFV, lopinavir\u002Fritonavir, and\u002For raltegravir within 14 days before entry.\n9. The child has received long-term immunosuppressive therapy (more than eight days) within 30 days before entry. Note: Short courses of steroids (seven days or less) may be allowed with approval.\n10. The child is a result of a multiple birth (e.g., twins, triplets).\n11. The child has any other significant medical condition that would make participation unsafe, complicate data interpretation, or interfere with study objectives, as determined by the site investigator.",{"count":233,"type":23},144,[235,203],"PHASE1","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.",[206],[109,206,239],"Latent Tuberculosis",{"date":82,"type":35},{"date":242,"type":23},"2026-10-15",{"date":244,"type":23},"2028-05-31",{"name":222,"class":223},11,{"id":248,"slug":249,"hasResults":12,"nctId":250,"briefTitle":251,"officialTitle":252,"acronym":253,"eligibilityCriteria":254,"healthyVolunteers":12,"sex":52,"minAge":53,"maxAge":4,"enrollmentInfo":255,"targetDuration":4,"studyType":24,"phases":257,"briefSummary":258,"conditions":259,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":261,"startDateStruct":262,"completionDateStruct":264,"leadSponsor":266,"locationsCount":224},"100530851","phase-2-trial-of-novel-regimens-for-the-treatment-of-pulmonary-tuberculosis-100530851","NCT06192160","Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis","A Phase 2 Randomized, Adaptive, Dose-Ranging, Open-Label Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis","RAD-TB","Inclusion Criteria:\n\n1. Pulmonary TB (among individuals either without history of prior TB treatment or with history of TB treatment completed more than 2 years prior to study entry), identified within 7 days prior to study entry by at least one sputum specimen positive for Mtb by Xpert. Semiquantitative Mtb results of \"medium\" or \"high\" from Xpert MTB\u002FRIF Ultra are required.\n2. Pulmonary TB with documented INH susceptibility (by Line Probe Assay (LPA) or Xpert MTB\u002FXDR or other validated molecular test) and with documented RIF susceptibility (by LPA or Xpert MTB\u002FRIF or Xpert MTB\u002FRIF Ultra or other validated molecular test) within 7 days prior to study entry.\n3. Documentation of HIV-1 infection status, as below:\n\n   Presence or absence of HIV-1 infection, as documented by:\n   * Any licensed rapid HIV test or HIV-1 enzyme or chemiluminescence immunoassay (E\u002FCIA) test kit, any time prior to study entry. AND for a positive result confirmation by one of the following:\n   * A second antibody test from different manufacturers or based on different principles and epitopes (combination antigen-antibody-based rapid tests may be used), or\n   * HIV-1 antigen, or\n   * Plasma HIV-1 RNA viral load, or\n   * A licensed Western blot\n4. For individuals with HIV: CD4+ cell count ≥100 cells\u002Fmm3 based on testing performed within 30 days prior to study entry.\n5. For individuals with HIV: Currently being treated with dolutegravir-based antiretroviral therapy (ART), or plan to initiate dolutegravir-based ART at or before study week 8.\n6. Individuals age ≥18 years.\n7. The following laboratory values obtained within 7 days prior to study entry at any network-approved non-U.S. laboratory that operates in accordance with Good Clinical Laboratory Practices (GCLP) and participates in appropriate external quality assurance programs:\n\n   * Serum or plasma alanine aminotransferase (ALT) ≤3 times the upper limit of normal (ULN)\n   * Serum or plasma total bilirubin ≤2 times ULN\n   * Serum or plasma creatinine ≤2 times ULN\n   * Serum or plasma potassium ≥3.5 mEq\u002FL\n   * Serum or plasma magnesium ≥1.0 mEq\u002FL (≥0.500 mmol\u002FL)\n   * Absolute neutrophil count (ANC) ≥1500\u002Fmm\\^3\n   * Hemoglobin ≥9.0 g\u002FdL\n   * Platelet count ≥100,000\u002Fmm\\^3\n   * Negative for, hepatitis B surface antigen (HBsAg)\n   * Negative for hepatitis C virus (HCV) antibody (or if HCV antibody positive, must have a negative HCV PCR)\n8. For female study candidates who are of reproductive potential, negative pregnancy test (urine HCG or serum β-HCG) within 3 days (72 hours) prior to entry by any network-approved non-U.S. laboratory or clinic that operates in accordance with GCLP and participates in appropriate external quality assurance programs.\n\n   Females who are of reproductive potential and who participate in sexual activity that could lead to pregnancy must agree to use at least two of the following forms of birth control while receiving TB study medications and for 12 months after stopping study medications:\n   * Male or female condoms\n   * Diaphragm or cervical cap (with spermicide, if available)\n   * Intrauterine device (IUD) or intrauterine system (IUS)\n   * Hormone-based birth control (e.g., oral contraceptives, Depo-Provera, NuvaRing, implants)\n\n   Female study candidates who are of reproductive potential, but who abstain from sexual activity that could lead to pregnancy require no additional contraception.\n\n   Female study candidates who are not of reproductive potential are eligible without requiring the use of contraceptives. Self-reported history is acceptable documentation of menopause (i.e., at least 1 year amenorrheic), hysterectomy, bilateral oophorectomy, or bilateral tubal ligation; these candidates are all considered not of reproductive potential.\n9. For male study candidates who engage in sexual activity that may lead to pregnancy in their partner must agree to either remain abstinent or use male contraceptives. They are also strongly advised to inform their non-pregnant sexual partners of reproductive potential to use effective contraceptives while the individual is on study and for 90 days after experimental treatment discontinuation.\n\n   For male study candidates who have undergone successful vasectomy with documented azoospermia or have documented azoospermia for any other reason, are eligible without requiring the use of contraceptives.\n10. For male study candidates with pregnant partners, willingness to use condoms during vaginal intercourse while on study and for 90 days after experimental treatment discontinuation.\n11. For male study candidates, willingness to refrain from sperm donation while on study and for 90 days after experimental treatment discontinuation.\n12. Documentation of Karnofsky performance score ≥60 obtained within 14 days prior to study entry.\n13. Chest x-ray obtained within 14 days prior to study entry.\n14. A verifiable address or residence readily accessible for visiting, and willingness to inform the study team of any change of address during study treatment and follow-up period.\n15. Ability and willingness of individual to provide informed consent.\n\nExclusion Criteria:\n\n1. More than cumulative 7 days of treatment directed against active TB for the current TB episode in the 60 days preceding study entry.\n2. Current extrapulmonary TB, in the opinion of the investigator.\n3. QTcF interval \\>450 ms within 7 days prior to study entry.\n4. History of or ongoing heart failure.\n5. Personal or family history of congenital QT prolongation.\n6. History of known, untreated, ongoing hypothyroidism.\n7. History of or ongoing bradyarrhythmia.\n8. History of torsades de pointes.\n9. Current Grade 2 or higher peripheral neuropathy.\n10. Other medical conditions (e.g., diabetes, liver or kidney disease, blood disorders, chronic diarrhea), in the opinion of the site investigator, in which the current clinical condition of the participant is likely to prejudice the response to, or assessment of, treatment.\n11. Pregnant or breastfeeding or planning to become pregnant within the next 12 months.\n12. Weight \\\u003C35 kg.\n13. Unable to take oral medications.\n14. Taking any of prohibited medications.\n15. Known allergy\u002Fsensitivity or any hypersensitivity to components of investigational agents or their formulation.\n16. Active drug or alcohol use or dependence; or mental illness (e.g., major depression) that, in the opinion of the site investigator, would interfere with adherence to study requirements.\n17. Taking an investigational drug or vaccine within 30 or more days prior to study entry.",{"count":256,"type":23},315,[203],"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.",[260],"Pulmonary Tuberculosis",{"date":113,"type":35},{"date":263,"type":35},"2025-03-11",{"date":265,"type":23},"2027-08-11",{"name":222,"class":223},{"id":268,"slug":269,"hasResults":12,"nctId":270,"briefTitle":271,"officialTitle":272,"acronym":4,"eligibilityCriteria":273,"healthyVolunteers":12,"sex":52,"minAge":4,"maxAge":274,"enrollmentInfo":275,"targetDuration":4,"studyType":24,"phases":277,"briefSummary":278,"conditions":279,"keywords":281,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":283,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":288,"locationsCount":289},"100219916","phase-1-very-early-intensive-treatment-of-infants-living-with-hiv-to-achieve-hiv-remission-100219916","NCT02140255","Very Early Intensive Treatment of Infants Living With HIV to Achieve HIV Remission","Very Early Intensive Treatment of Infants Living With HIV to Achieve HIV Remission: A Phase I\u002FII Proof of Concept Study","Maternal Inclusion Criteria\n\n1. Presumed or confirmed maternal HIV infection:\n\n   * Mothers will be eligible to enroll with EITHER:\n\n     * Presumed HIV infection defined as at least one positive rapid HIV antibody-based test result from a sample collected in the peripartum period. Presumed infection must be confirmed within 10 business days of enrollment OR\n     * Confirmed HIV infection defined as positive results from two samples collected at different timepoints\n2. Willing and able to provide written informed consent for participation of herself and her infant. The mother must be of legal age or circumstance to provide independent informed consent as determined by site standard operating procedures (SOPs) and consistent with IRB\u002FEC policies and procedures. Otherwise, informed consent must be obtained from a legal guardian and the mother must provide written assent.\n3. Was not previously enrolled in this study with another infant.\n4. Did not receive ARVs during the current pregnancy.\n5. Infant is eligible per inclusion criteria.\n\nInfant Inclusion Criteria for Step 1\n\n1. Less than or equal to 48 hours of age.\n2. Greater than or equal to 37 weeks gestational age at birth (assessment of gestational age will be based on the best clinical estimate determined by date of last menstrual period, antenatal ultrasound, fundal height, or Ballard Score).\n3. Greater than or equal to 2 kilograms (kg) at birth.\n4. Able to take ARVs by mouth, nasogastric tube, or gastrostomy tube.\n5. Has no clinically significant diseases (other than HIV infection) or clinically significant findings during review of medical history or physical examination prior to entry that, in the site investigator's opinion, would interfere with study participation or interpretation.\n6. Mother is eligible per inclusion criteria.\n\nInfant Inclusion Criteria for Step 2\n\n1. Enrolled in Step 1.\n2. Confirmed in utero HIV infection.\n3. Able to take ARVs by mouth, nasogastric tube, or gastrostomy tube.\n4. Has no clinically significant diseases (other than HIV infection) or clinically significant findings during review of medical history or physical examination prior to entry that, in the site investigator's opinion, would interfere with study participation or interpretation.\n5. Mother (or legal guardian if applicable) is willing and able to provide written informed consent for child's participation in Step 2.\n\nInfant Inclusion Criteria for Step 3\n\n1. Enrolled in Step 2.\n2. Has reached Step 2 Week 96.\n3. Has the following results based on testing:\n\n   * No confirmed plasma HIV RNA ≥200 copies\u002FmL at Step 2 Week 24 and up to but excluding Step 2 Week 48.\n   * No plasma HIV RNA detected at Step 2 Week 48 and thereafter, with two possible exceptions\n\n     * (i) First possible exception: If HIV RNA is detected at or after Step 2 Week 48 with a result \\\u003C200 copies\u002FmL, testing will be repeated within three weeks (specimen collection for the confirmatory test must occur within three weeks of specimen collection for the initial test).\n     * If no HIV RNA is detected on the confirmatory test, or if HIV RNA is detected with a result \\\u003C200 copies\u002FmL, the infant will be potentially eligible for Step 3 after an additional 48 weeks of follow-up in Step 2, provided no HIV RNA is detected on any subsequent tests in Step 2.\n     * If HIV RNA is detected on the confirmatory test with a result ≥200 copies\u002FmL, the infant will not be eligible for Step 3.\n     * (ii) Second possible exception: If HIV RNA is detected after Step 2 Week 48 with a result \\\u003CLOD, the infant will be potentially eligible for Step 3 after an additional 48 weeks of follow-up in Step 2 with no RNA detected. There is no limit on the number of times HIV RNA may be detected with a result \\\u003CLOD after Week 48. However, infants with detectable RNA with a result \\\u003CLOD after Week 48 will not be considered for entry into Step 3 until after an additional 48 weeks of no RNA detected.\n     * Participants may experience either or both exceptions at different timepoints during follow-up in Step 2.\n4. If breastfed, must have permanently ceased breastfeeding, with no exposure to breast milk for at least six weeks prior to specimen collection for the testing specified in the criterion (#5) below.\n5. Has met ALL of the following additional criteria while in Step 2, based on testing between Step 2 Week 84 and Step 2 Week 192 (inclusive):\n\n   * Two consecutive negative HIV antibody tests by fourth generation ELISA at least eight weeks apart.\n   * Two consecutive HIV DNA tests with no DNA detected in at least 850,000 PBMCs assayed at least eight weeks apart.\n   * CD4 cell percentage greater than or equal to 25% and CD4 cell absolute count greater than or equal to the lower limit of normal for age (≥1000 cells\u002FmL if 2 to less than 3 years of age; ≥750 cells\u002FmL if 3 to less than 5 years of age; ≥500 cells\u002FmL if 5 years of age or older).\n   * Infant assessed by the site investigator or designee as expected to adhere to the Step 3 Schedule of Evaluations.\n   * Mother (or legal guardian if applicable) willing and able to provide written informed consent for child's participation in Step 3 and Step 4.\n6. No plasma HIV RNA detected by testing after criteria have been confirmed, with specimen collection for the assay within 14 days prior to Step 3 Entry.\n\nInfant Inclusion Criteria for Step 4\n\n1. Enrolled in Step 3.\n2. Has met at least one of the following:\n\n   * Plasma HIV RNA ≥LOD based on two assays.\n   * Plasma HIV RNA ≥1000 copies\u002FmL in the presence of fever or other sign or symptom of acute retroviral syndrome.\n   * Confirmed or suspected diagnosis of acute retroviral syndrome.\n   * Confirmed or suspected diagnosis of a new WHO Clinical Stage 3 or 4 condition.\n   * Confirmed CD4 cell percentage less than 25% and CD4 cell absolute count less than the lower limit of normal for age (\\\u003C1000 cells\u002FmL if 2 to less than 3 years of age; \\\u003C750 cells\u002FmL if 3 to less than 5 years of age; \\\u003C500 cells\u002FmL if 5 years of age or older).\n   * Otherwise assessed by the site investigator or designee, in consultation with the Clinical Management Committee (CMC), as having an indication to re-initiate treatment.","48 Hours",{"count":276,"type":23},1120,[235,203],"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.",[280],"HIV Infection",[282],"HIV Remission",{"date":82,"type":35},{"date":285,"type":35},"2015-01-23",{"date":287,"type":23},"2031-12-31",{"name":222,"class":223},46,{"id":291,"slug":292,"hasResults":12,"nctId":293,"briefTitle":294,"officialTitle":295,"acronym":296,"eligibilityCriteria":297,"healthyVolunteers":12,"sex":52,"minAge":4,"maxAge":4,"enrollmentInfo":298,"targetDuration":4,"studyType":24,"phases":300,"briefSummary":301,"conditions":302,"keywords":304,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":306,"lastUpdatePostDateStruct":307,"startDateStruct":308,"completionDateStruct":310,"leadSponsor":312,"locationsCount":314},"100559772","phase-2-bedaquiline-roll-out-evidence-in-contacts-and-people-living-with-hiv-to-prevent-tb-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":299,"type":23},2530,[203,26],"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.",[303],"Tuberculosis, Latent",[305],"Bedaquiline","2026-08-16",{"date":113,"type":35},{"date":309,"type":35},"2026-05-08",{"date":311,"type":23},"2027-09",{"name":313,"class":90},"Johns Hopkins University",8,{"id":316,"slug":317,"hasResults":12,"nctId":318,"briefTitle":319,"officialTitle":320,"acronym":4,"eligibilityCriteria":321,"healthyVolunteers":17,"sex":52,"minAge":322,"maxAge":323,"enrollmentInfo":324,"targetDuration":4,"studyType":24,"phases":326,"briefSummary":327,"conditions":328,"keywords":331,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":336,"lastUpdatePostDateStruct":337,"startDateStruct":338,"completionDateStruct":340,"leadSponsor":342,"locationsCount":91},"100652326","insecticide-treated-baby-wraps-for-the-prevention-of-malaria-100652326","NCT07773350","Insecticide-Treated Baby Wraps for the Prevention of Malaria","Factory-Treated, Long-Lasting Insecticide-Treated Baby Wraps for the Prevention of Malaria: A Phase III Clinical Trial","Inclusion Criteria:\n\n* Mother is at least 18 years old\n* Mother has access to a working phone with a known number\n* Mother is the parent or legal guardian of a singleton (i.e., not a twin) infant 2-4 months of age\n* Has the ability to travel to a designated study site for visits and evaluation\n* Mother\u002FInfant pair presents to their 10-week immunization visit at one of the designated study sites\n\nExclusion Criteria:\n\n* Participation in another study of malaria prevention\n* Known allergic reaction to permethrin or etofenprox\n* Infant has a known HIV diagnosis (or exposure) or sickle cell disease that would be an indication for malaria prophylaxis","2 Months","99 Years",{"count":325,"type":23},1296,[78],"The objective is to test the protective effect of permethrin-treated and etofenprox-treated lesus against malaria in young children",[329,330],"Malaria (Plasmodium Falciparum)","Malaria Incidence",[332,333,334,335],"Lesu","Malaria","Permethrin","Etofenprox","2026-08-14",{"date":82,"type":35},{"date":339,"type":23},"2027-01-01",{"date":341,"type":23},"2031-01-01",{"name":343,"class":90},"University of North Carolina, Chapel Hill",{"id":345,"slug":346,"hasResults":12,"nctId":347,"briefTitle":348,"officialTitle":349,"acronym":4,"eligibilityCriteria":350,"healthyVolunteers":17,"sex":52,"minAge":4,"maxAge":4,"enrollmentInfo":351,"targetDuration":4,"studyType":24,"phases":353,"briefSummary":355,"conditions":356,"keywords":358,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":361,"lastUpdatePostDateStruct":362,"startDateStruct":363,"completionDateStruct":365,"leadSponsor":367,"locationsCount":91},"100594590","early-phase-1-focal-mass-drug-administration-for-the-prevention-of-malaria-in-pregnancy-100594590","NCT07021430","Focal Mass Drug Administration for the Prevention of Malaria in Pregnancy","Focal Mass Drug Administration for the Prevention of Malaria in Pregnancy: a Pilot Randomized Controlled Trial","Inclusion Criteria:\n\n* Primary residence (i.e., where a person lives for ≥ 6 months per year) in Kasese District with no plans to change residency in subsequent 6 months\n* Able and willing to comply with all study procedures and be available for the duration of the study\n* Able and willing to consent to study procedures as documented on informed consent form. For children (age \\\u003C18 years), parent or guardian must provide consent. Children age ≥8 to 17 years will also be asked to provide written assent.\n\nEach pregnant women will also need to meet additional eligibility criteria:\n\n18 years old or older Presenting to Bugoye Level III Health Center for antenatal care and plan to deliver at Bugoye Level III Health Center (i.e., not planned cesarean section) Gestational age ≤22 weeks Human Immunodeficiency Virus negative\n\nExclusion Criteria:\n\n* An individual who meets any of the following criteria will be excluded from participation:\n* Temporary or part-time residence in Kasese District (i.e., where a person lives for \\\u003C 6 months per year)\n* Known plans to move within the next 6 months\n* Unable or unwilling to provide consent\n* Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study\n\nIn addition, individuals with any of the following will still be eligible to participate (e.g,, complete surveys, provide blood samples) but will not be eligible to receive Dihydroartemisinin Piperaquine if randomized to one of the intervention arms:\n\n* Known arrythmia, QT prolongation, or seizure disorder will not be eligible to receive Dihydroartemisinin Piperaquine\n* Use of potentially contraindicated medications outlined in Section 5.6\n* Weight \\\u003C5 kg\n* Known allergic reaction to Dihydroartemisinin Piperaquine or other Artemisinin Combination Therapies",{"count":352,"type":23},300,[354],"EARLY_PHASE1","The purpose of this study is to demonstrate the feasibility, acceptability, and preliminary effectiveness of a focal mass drug administration program for household members of pregnant women to protect against malaria in pregnancy.",[357],"Malaria Prevention",[333,359,360],"Focal mass drug administration","Dihydroartemisinin-piperaquine","2026-08-13",{"date":184,"type":35},{"date":364,"type":23},"2026-09-27",{"date":366,"type":23},"2028-09",{"name":343,"class":90},{"id":369,"slug":370,"hasResults":12,"nctId":371,"briefTitle":372,"officialTitle":373,"acronym":374,"eligibilityCriteria":375,"healthyVolunteers":12,"sex":52,"minAge":130,"maxAge":4,"enrollmentInfo":376,"targetDuration":4,"studyType":24,"phases":378,"briefSummary":379,"conditions":380,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":381,"lastUpdatePostDateStruct":382,"startDateStruct":383,"completionDateStruct":385,"leadSponsor":387,"locationsCount":389},"100563138","phase-3-a-study-to-evaluate-how-well-etavopivat-works-in-people-with-sickle-cell-disease-100563138","NCT06612268","A Study to Evaluate How Well Etavopivat Works in People With Sickle Cell Disease","A Global Phase 3, Randomised, Double-blind and Placebo-controlled Study Evaluating the Efficacy and Safety of Etavopivat in Adolescents and Adults With Sickle Cell Disease","Hibiscus 2","Inclusion Criteria:\n\n* Male or female.\n* Age 12 years or above at the time of signing the informed consent.\n* Confirmed diagnosis of sickle cell disease: Documentation of sickle cell disease (SCD) genotype (HbSS, HbSβ0-thalassemia or other sickle cell syndrome variants) based on prior history of laboratory testing or screening test results from central laboratory. Molecular genotyping is not required. SCD genotype may be determined from the results of haemoglobin (Hb) electrophoresis, high-performance liquid chromatography (HPLC) or similar testing. Note that Hb electrophoresis is performed by the central laboratory at screening.\n* Have 1-15 episodes of documented vaso occlusive crises (VOC) within the 12 months prior to screening. Documentation must exist in the participant's medical record prior to randomisation. Events based solely on participant recall without supporting documentation should not be counted towards eligibility.\n* Hb greater than or equal to (≥) 5.0 and less than or equal to (≤) 10.0 g\u002FdL (greater than or equal to (≥) 50 and less than or equal to (≤) 100 g\u002FL) at screening.\n\nExclusion Criteria:\n\n* More than 15 VOCs within the past 12 months prior to screening documented in the participant's medical record. Events based solely on participant recall without supporting documentation should not be counted towards eligibility.\n* Use of voxelotor or similar agent within 28 days prior to starting study treatment or anticipated need for this agent during the study.\n* Use of a selectin antagonist (e.g., crizanlizumab, monoclonal antibody or small molecule) within 28 days or 5 half-lives (whichever is longer) prior to starting study treatment or anticipated need for such agents during the study.\n* Receiving regularly scheduled blood (RBC) transfusion therapy (also termed chronic, prophylactic, or preventive transfusion) or greater than or equal to 6 transfusion events in the previous 12 months (i.e., an average of 1 transfusion event every 60 days).\n* Participants who have received an RBC transfusion for any reason within 60 days of the screening period or 60 days of the randomisation day are only eligible if HbA (adult haemoglobin) less than 10% by Hb electrophoresis is documented prior to starting study treatment.\n* Receiving or use of concomitant medications that are strong inducers of CYP3A4 (cytochrome p450 3a4) within 2 weeks of starting study treatment or anticipated need for such agents during the study.\n* Use of erythropoietin or other haematopoietic growth factor treatment within 28 days of starting study treatment or anticipated need for such agents during the study.\n* Receipt of prior cellular-based therapy (e.g., haematopoietic cell transplant, gene modification therapy).\n* Hepatic dysfunction characterized by:\n\n  * Alanine aminotransferase (ALT) greater than 4.0 × upper limit of normal (ULN) or\n  * Direct bilirubin greater than 3.0 × ULN.\n* Participants who are not taking or are unable to take antimalarial prophylaxis at the time of consent and during the study if they live in areas of endemic malaria where prophylaxis is recommended.\n* Severe renal dysfunction (estimated glomerular filtration rate \\[eGFR\\] at screening, calculated by the central laboratory greater than 30 mL\u002Fmin\u002F1.73 m\\^ 2) or on chronic dialysis.\n* Travelled distance on standardized 6MWT below 100m at screening.",{"count":377,"type":23},408,[26],"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.",[137],"2026-08-12",{"date":361,"type":35},{"date":384,"type":35},"2025-02-17",{"date":386,"type":23},"2029-08-12",{"name":388,"class":42},"Novo Nordisk A\u002FS",175,{"id":391,"slug":392,"hasResults":12,"nctId":393,"briefTitle":394,"officialTitle":395,"acronym":396,"eligibilityCriteria":397,"healthyVolunteers":12,"sex":52,"minAge":53,"maxAge":4,"enrollmentInfo":398,"targetDuration":4,"studyType":24,"phases":400,"briefSummary":401,"conditions":402,"keywords":404,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":408,"lastUpdatePostDateStruct":409,"startDateStruct":410,"completionDateStruct":412,"leadSponsor":414,"locationsCount":416},"100624302","call-for-life-sepsis-100624302","NCT07407868","Call for Life Sepsis","Evaluating The Impact on 90-day Survival Of Post-Discharge Follow-up Strategies Delivered To Adult Patients Hospitalized With Sepsis Across A Research Network In Sub-Saharan Africa","C4L-Sepsis","Inclusion Criteria:\n\n* At admission\n\n  1. Adults ≥18 years.\n  2. Participant's hospital admission diagnosis is consistent with the following broad definition of sepsis, incorporating its principal components (signs of infection plus signs of severity\u002Forgan dysfunction):\n\n     1. Signs of infection: Suspected or proven infection, as determined by the medical team in charge.\n     2. Illness severity: Decision of the medical team to admit the patient to an adult medical ward of the study hospital, according to clinical appraisal of the treating physician and applicable guidelines.\n  3. Participant\u002Fproxy is willing to have their medical records reviewed by the trial team and get daily follow-ups until the time of discharge and to be approached again by the study team for a second informed consent process towards the time of hospital discharge.\n  4. Evidence of a personally signed and dated informed consent form stating that the participant\u002Fproxy has been informed of, had opportunity to ask questions about and have consented to the initial study procedures that will be conducted during their hospitalization. At discharge\n  5. Patient has overcome the critically ill phase of their hospitalization and is, according to the non-study clinical team caring for the patient, expected to be discharged within the next 24 hours.\n  6. Participant is willing and able to comply with scheduled phone follow-ups, and other study procedures.\n  7. Evidence of a personally signed and dated informed consent form stating that the participant has been informed of, had opportunity to ask questions about and have consented to all procedures that will be conducted at the time of and after their discharge, and alternatives and risks for the study.\n  8. The participant confirms that there is availability of mobile network coverage in their place of residence.\n\nExclusion Criteria:\n\nAt Admission;\n\n1. Patient who requires hospitalization for a condition that requires emergent or urgent obstetric or surgical intervention (including burns, trauma, abscess)\n2. Persons who are currently or have been previously enrolled into this study.\n3. Patient is terminally ill due to an underlying condition other than sepsis.\n4. The patient is a detainee or prisoner.\n5. The patient is unable to speak English and Luganda.\n\n   * At Discharge:\n\n   At discharge\n6. The patient is unable to hear.\n7. Participant states they will be unable to return to same health facility for the scheduled 14-day post-discharge clinic assessment (provided by the non-study clinical team)\n8. Patients requiring clinical care for more than 10 days (if clinical care was completed and participant is ready for discharge but are still in hospital for financial or logistical reasons beyond 10 days, they can still be eligible)",{"count":399,"type":23},1410,[78],"Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis-attributable mortality in sub-Saharan Africa (sSA) is high, with in-hospital mortality in some settings approaching 40%. Studies show that mortality among children under 5 years hospitalized with sepsis remains high within the first 6 months of discharge. Additionally, high mortality has been observed among other populations within sSA, with factors such as HIV infection being associated with increased risk. Reducing sepsis deaths contributes to the achievement of the Sustainable Development Goals (SDG), particularly SDG 3 in reducing maternal mortality (3.1), neonatal and under five mortality (3.2), and burden of mortality from communicable diseases (3.3) and improving universal health coverage (3.8). The World Health Organization (WHO) has recognized sepsis as a global priority, with low- and middle-income settings being particularly affected. In sSA, sepsis is commonly associated with infectious diseases like malaria, Human Immunodeficiency Virus\u002F Acquired Immunodeficiency Syndrome (HIV\u002FAIDS), pneumonia, tuberculosis, and diarrhea. Guidelines from the Surviving Sepsis Campaign (SSC) have become standard in some settings. However, little is known about patients' status post-discharge. This study aims to evaluate two post-discharge follow-up strategies for adult sepsis patients. Study duration is 45 months, participants will receive intervention up to 90 days post discharge.\n\nDescription of intervention: Post-discharge follow-up strategy 1: Enhanced Discharge Intervention (EDI) Post-discharge follow-up strategy 2: EDI plus Interactive Voice Response (IVR)\n\n\\*All participants will receive a feature phone.\n\nObjectives:\n\nThe study aims to evaluate two post-discharge follow-up strategies for adult patients hospitalized with sepsis, focusing on their efficacy in reducing the 90-day mortality, and their effect on return to follow-up, number of re-admissions, and quality of life.\n\nPrimary efficacy endpoint\n\n* 90- day all-cause mortality post discharge Secondary end points\n* Time to death\n* 28-day all-cause mortality\n* Attendance within 14-day check-up post discharge\n* Re-admission within 28 and 90 days\n* Days alive and out of hospital (DAOH)\n* Quality of life score (Baseline vs 28 day and Baseline vs 90 days)\n* Differences in baseline demographic and clinical characteristics (e.g., age, sex, disease severity, comorbidities, key laboratory values) between randomized participants and screen failures. Study design: This is an open-label, randomized, parallel, interventional study, with two post-discharge follow-up strategies: 1) EDI; or 2) EDI plus IVR system. Fixed allocation randomization at a 1:1 ratio will be applied to either study arm.\n\nSample size: A total of 1,410 (705 per arm) from the four countries (Uganda, Nigeria, Ghana and Mozambique) will be enrolled competitively across the sites.",[403],"Sepsis",[405,406,407],"Reduce post discharge sepsis mortality,","Interactive Voice Response System,","Call for life - IVR","2026-08-10",{"date":381,"type":35},{"date":411,"type":35},"2026-06-10",{"date":413,"type":23},"2028-06-15",{"name":415,"class":90},"Makerere University",2,{"id":418,"slug":419,"hasResults":12,"nctId":420,"briefTitle":421,"officialTitle":422,"acronym":423,"eligibilityCriteria":424,"healthyVolunteers":12,"sex":52,"minAge":425,"maxAge":426,"enrollmentInfo":427,"targetDuration":4,"studyType":24,"phases":429,"briefSummary":430,"conditions":431,"keywords":436,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":442,"lastUpdatePostDateStruct":443,"startDateStruct":444,"completionDateStruct":446,"leadSponsor":448,"locationsCount":91},"100650974","different-treatment-frequencies-for-hepatic-fibrosis-due-to-schistosomiasis-an-rct-100650974","NCT07754617","Different Treatment Frequencies for Hepatic Fibrosis Due to Schistosomiasis","An RCT to Evaluate Different Treatment Approaches to Mitigate the Progression of Schistosomiasis Related Hepatic Fibrosis","SchiFT","Inclusion Criteria:\n\n1. S. mansoni infection as determined by urine Circulating Cathodic Antigen (CCA)\n2. Otherwise healthy as determined by history and physical examination conducted by the study clinician\n3. Not Pregnant\n4. Age 15-40 years\n5. Consent for individuals 18 years of age and older, and parental consent and adolescent assent for participants ages 15-17 years.\n6. The presence of hepatic fibrosis due to S. mansoni (Niamey protocol grade C-F) and compensated (without late-stage portal hypertension) after ruling out other causes of hepatic fibrosis as below.\n\nExclusion Criteria:\n\n1. . History of upper gastrointestinal bleeding\n2. Hepatic fibrosis that is not deemed to be due to schistosomiasis based on ultrasound and hepatitis serologies. For example, alcoholic cirrhosis or presence of chronic Hepatitis B or C by point of care test\n3. Known neurocysticercosis or ocular cysticercosis","15 Years","40 Years",{"count":428,"type":23},600,[203,26],"The goal of this clinical trial is to learn if treating individuals living in Uganda who have liver fibrosis (scarring) due to schistosomiasis would benefit from more frequent treatment with drug praziquantel. This drug is already approved to treat schistosomiasis and is used globally. The study will include individuals who have schistosomiasis and some degree of liver fibrosis. The main questions it aims to answer are:\n\n1. Does treating participants three times per year as compared to once per year as currently recommended improve the likelihood the hepatic fibrosis will improve over three years.\n2. Does treating participants three times per year as compared to once per year as currently recommended decrease the risk they have for bleeding due to portal hypertension over three years.\n3. Is there a blood test that can tell us which individuals will experience worsening liver fibrosis before this happens.\n\nParticipants will:\n\nBe screened for schistosomiasis using a urine test If participants have schistosomiasis they will undergo other screening procedures including a liver ultrasound, blood tests, and a physical exam if they have both schistosomiasis and liver (fibrosis) they will be invited to participate in the trial\n\nIf they are in the trial they will:\n\nTake the drug praziquantel once per year or three times per year based on randomization for three years Have a liver ultrasound and blood samples for markers of liver fibrosis once per year Provide a urine sample to test for schistosomiasis each year",[432,433,434,435],"Schistosomiasis","Schistosoma Mansoni","Liver Fibrosis","Portal Hypertension",[437,438,439,440,441],"schistosomiasis","schistosome mansoni","hepatic fibrosis","liver fibrosis","portal hypertension","2026-08-07",{"date":381,"type":35},{"date":445,"type":23},"2026-11",{"date":447,"type":23},"2029-11",{"name":449,"class":90},"Rhode Island Hospital",{"id":451,"slug":452,"hasResults":12,"nctId":453,"briefTitle":454,"officialTitle":455,"acronym":4,"eligibilityCriteria":456,"healthyVolunteers":12,"sex":52,"minAge":4,"maxAge":4,"enrollmentInfo":457,"targetDuration":4,"studyType":24,"phases":458,"briefSummary":459,"conditions":460,"keywords":462,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":442,"lastUpdatePostDateStruct":464,"startDateStruct":466,"completionDateStruct":467,"leadSponsor":469,"locationsCount":472},"100500546","phase-2-a-study-of-propranolol-to-treat-kaposi-sarcoma-100500546","NCT05797662","A Study of Propranolol to Treat Kaposi Sarcoma","A Phase II Study of Propranolol for the Treatment of Kaposi Sarcoma in Children and Adults","Inclusion Criteria:\n\n* Pediatric (\\\u003C 18 years) and adult (≥ 18 years) participants with biopsy-proven and measurable Kaposi Sarcoma (KS) as defined in the KS Manual of Procedures (MOP).\n* No urgent clinical indication for immediate cytotoxic chemotherapy. Participants who have received cytotoxic chemotherapy \\> 4 weeks prior to screening are eligible.\n* KS stage:\n\n  * \\\u003C 18 years:\n\n    * 1A (Mild): disease limited to skin, flat oral mucosal lesions, and\u002For flesh colored subcutaneous nodules, total \\\u003C10 lesions.\n    * 1B (Moderate): having any of the following features, alone or in combination: a total of 10-19 hyperpigmented skin\u002Foral lesions, nodular oral involvement, conjunctival eye involvement, or exophytic mass.\n  * ≥ 18 years:\n\n    * T0: confined to skin and\u002For lymph nodes and\u002For minimal oral lesions.\n    * T1: limited to tumor-associated edema of cutaneous lesions without functional impairment or flat oral lesions.\n* Performance Status:\n\n  * \\\u003C 18 years:\n\n    * Lansky performance status \\> 70%\n  * ≥ 18 years:\n\n    * Easter Cooperative Oncology Group (ECOG) performance status ≤ 2\n* Participants must have adequate organ function, as defined by the following:\n\n  * Bilirubin (direct or total) within normal range, or total bilirubin \\\u003C3.0 mg\u002Fdl for participants with Gilbert syndrome.\n  * Calculated creatinine clearance ≥ 30 mL\u002Fmin for participants ≥ 12 years (see Appendix III); creatinine \\\u003C1.5 Upper Limit Normal (ULN) for participants \\\u003C 12 years.\n  * Hemoglobin \\> 9 g\u002FdL;\n  * Platelets \\> 100 × 109\u002FL;\n  * ANC \\> 1000 cells\u002Fmm3\n* Human Immunodeficiency Virus (HIV) positive participants must be on antiretroviral therapy (ART) that conforms to local standards of care. Participants will have been on ART for at least 12 weeks. Participants will not be excluded based on CD4 count or HIV viral load.\n* HIV positive participants must not show recent improvement on ART that may confound response evaluation:\n\n  * If on ART 12 to 24 weeks, participants must show evidence of KS progression requiring further systemic treatment.\n  * If on ART for \\>24 weeks, must show no evidence of regression in the last eight weeks.\n* HIV-negative participants must not show evidence of improvement in the three months prior to enrollment.\n* No history of asthma or diabetes mellitus (as it is a risk factor for hypoglycemia).\n* No clinically significant cardiovascular disease other than hypertension, which is permitted.\n* No use of beta-adrenergic antagonists for other indications.\n* Not pregnant or planning to become pregnant. Propranolol is United Stats Food and Drug Administration (US FDA) pregnancy category C. At this time, the study team has determined that the unknown risk to a developing fetus is greater than the potential benefit of treatment.\n* Use of effective contraception for women of childbearing potential, defined as a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months.\n* Women of child bearing potential (WOCBP) must agree to use adequate contraception (oral contraceptive pills, intrauterine device, Nexplanon, Depo-Provera, or permanent sterilization, etc., or another acceptable method as determined by the investigator) prior to study entry, for the duration of study participation.\n* Not breast feeding.\n\nExclusion Criteria:\n\n• Participants who do not fulfill the criteria as listed in Section 3.1 above, are ineligible. Additionally, the presence of any of the following conditions will exclude a participant from study enrollment:\n\n* Children and adolescents with lymph node or visceral disease, woody edema, or ≥ 20 cutaneous lesions.\n* Children and adolescents with heart rate or systolic blood pressure \\\u003C10th percentile for age.\n* Adults with visceral disease or tumor-associated edema causing functional impairment.\n* Shortness of breath, hemoptysis, or moderate\u002Fsevere cough not attributable to causes other than KS.\n* Bleeding from the mouth or rectum not attributable to causes other than KS.\n* Treatment for active and serious infection.\n* Children with severe acute malnutrition based on World Health Organization (WHO) criteria (Mid-upper arm circumference \\\u003C11.5 cm, weight-for height Z-score \\\u003C-3 or presence of symmetrical pitting edema).\n* Given the risk of hypotension and hypoglycemia, participants must take the study drug with food. If needed, the study team will pursue additional funding to support providing supplemental food for participants who experience food insecurity.\n* Patients who experienced hypersensitivity to propranolol during initiation phase of treatment or had previous known allergy to propranolol or allergy to other β-blockers.\n* Patients with a history of uncompensated heart failure; severe sinus bradycardia; sick sinus syndrome; or heart block greater than first-degree.\n* Patients with diagnosed obstructive airway disease such as asthma, chronic obstructive pulmonary disease (COPD), or bronchiolitis.\n* History of diabetes mellitus (as it is a risk factor for hypoglycemia)\n* Patients receiving concurrent treatment with an anticancer therapy. Patients must not have received any anticancer therapies within 30 days prior to receiving the first dose of investigational treatment.\n* Patients with concern for Kaposi Sarcoma herpesvirus (KSHV) inflammatory cytokine syndrome.",{"count":7,"type":23},[203],"A clinical study of propranolol for the treatment of Kaposi Sarcoma in children and adults. This study will be an open-label single armed treatment trial that will test the effectiveness and the safety of treating Kaposi Sarcoma with propranolol.",[461],"Kaposi Sarcoma",[461,463],"Propranolol",{"date":465,"type":35},"2026-08-11",{"date":116,"type":23},{"date":468,"type":23},"2029-04",{"name":470,"class":471},"AIDS Malignancy Consortium","NETWORK",6,{"id":474,"slug":475,"hasResults":12,"nctId":476,"briefTitle":477,"officialTitle":478,"acronym":4,"eligibilityCriteria":479,"healthyVolunteers":12,"sex":52,"minAge":4,"maxAge":4,"enrollmentInfo":480,"targetDuration":4,"studyType":24,"phases":482,"briefSummary":483,"conditions":484,"keywords":4,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":486,"lastUpdatePostDateStruct":487,"startDateStruct":489,"completionDateStruct":491,"leadSponsor":493,"locationsCount":91},"100532420","keyscope-study-in-uganda-100532420","NCT06212570","KeyScope Study in Uganda","KeyScope: First-In-Human Clinical Study for Cancer Diagnosis in Uganda","Inclusion Criteria:\n\n* diagnosis of intra-abdominal mass suspicious for cancer\n* body mass index (BMI) of 18-30\n* weight 20-100kg\n* biopsy necessary to determine cancer diagnosis and classify pathology\n* surgeon determine that laproscopic biopsy it technically appropriate\n\nExclusion Criteria:\n\n* significant comorbidities\n* previous major abdominal surgery\n* current pregnancy",{"count":481,"type":23},12,[78],"KeyScope and KeyLoop (collectively called KeySuite) are laparoscopic prototypes that the investigators have designed for the resources, needs and challenges of low- and middle- income countries (LMICs). KeyScope is a laparoscope that plugs into a laptop computer to display images during surgery. It links to a telementoring application so that experienced surgeons can mentor surgeons in capacity-building partnerships. KeyLoop is a laparoscopic retractor that lifts the abdominal wall during surgery, obviating the need for a constant power supply and medical-grade carbon dioxide.\n\nThe investigators will perform a clinical First-in-Human study at the Uganda Cancer Institute. Ugandan surgeons will use the KeySuite devices to perform biopsies of intra-abdominal tumors.",[485],"Abdominal Neoplasm","2026-08-04",{"date":488,"type":35},"2026-08-06",{"date":490,"type":23},"2026-09-01",{"date":492,"type":23},"2028-06-30",{"name":494,"class":90},"Duke University",{"id":496,"slug":497,"hasResults":12,"nctId":498,"briefTitle":499,"officialTitle":499,"acronym":4,"eligibilityCriteria":500,"healthyVolunteers":12,"sex":52,"minAge":199,"maxAge":4,"enrollmentInfo":501,"targetDuration":503,"studyType":504,"phases":4,"briefSummary":505,"conditions":506,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":486,"lastUpdatePostDateStruct":508,"startDateStruct":510,"completionDateStruct":512,"leadSponsor":514,"locationsCount":416},"100501285","prevention-and-rehabilitation-of-stroke-in-uganda-100501285","NCT05807269","Prevention and Rehabilitation of Stroke in Uganda","Inclusion Criteria:\n\n* Stroke\n* Risk factors for stroke: hypertension, diabetes, HIV, malaria, physical inactivity, obesity\n\nExclusion Criteria:\n\n* Not having had stroke and\u002For having no risk factor for stroke",{"count":502,"type":23},50,"2 Years","OBSERVATIONAL","Stroke is increasing in low-income countries in Africa, and knowledge is lacking on risk factors and how to prevent stroke as well as how to best use the resources for rehabilitation after stroke which are very limited. Knowledge generation within this area is therefore urgently needed. This collaboration between the research group HELD (Health and Everyday Life among people with neurological Disorders), Karolinska Institutet (KI) and the research surveillant site Africa Medical and Behavioral Sciences Organization (AMBSO) population health surveillance (PHS), will create substantial research opportunities to develop and improve prevention and rehabilitation for stroke, which is in line with the sustainable development goals to reduce the prevalence and mortality rates due to NCDs. AMBSO is collecting data from 17 000 households on many potential risk factors for stroke. Questions about stroke primary and secondary prevention of stroke and impact of stroke or need of rehabilitation could be added to the existing questionnaires such as the validated Ugandan version of the Stroke Impact Scale. This is intended to fulfill the aim of the network which is to increase the knowledge of occurrence and consequences of NCDs with a specific focus on stroke, which will be valuable for the development of preventive healthcare policy documents and guidelines for appropriate prevention strategies and rehabilitation interventions.\n\nResearch questions in relation to NCDs with focus on stroke prevention and rehabilitation:\n\n* How many cases (prevalence) are reported in the targeted study sites and what is the mortality rate (incidence) that can specifically relate to stroke?\n* How does stroke and other NCDs affect and impact the quality of life for persons living in Uganda?\n* Which factors impact the recovery process after stroke?\n* What sort of rehabilitation is needed in the study areas for persons affected by stroke? In addition, risk factors of stroke such as diabetes and hypertension will be mapped.",[507],"Stroke",{"date":509,"type":35},"2026-08-05",{"date":511,"type":35},"2023-11-01",{"date":513,"type":23},"2028-03-31",{"name":515,"class":90},"Karolinska Institutet",{"id":517,"slug":518,"hasResults":12,"nctId":519,"briefTitle":520,"officialTitle":521,"acronym":522,"eligibilityCriteria":523,"healthyVolunteers":12,"sex":52,"minAge":524,"maxAge":525,"enrollmentInfo":526,"targetDuration":4,"studyType":504,"phases":4,"briefSummary":528,"conditions":529,"keywords":531,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":540,"lastUpdatePostDateStruct":541,"startDateStruct":542,"completionDateStruct":544,"leadSponsor":546,"locationsCount":548},"100650556","assessing-vaccine-effectiveness-of-r21matrix-m-across-malaria-transmission-settings-avert-100650556","NCT07749911","Assessing Vaccine Effectiveness of R21\u002FMatrix-M Across Malaria Transmission Settings (AVERT)","Real-World Effectiveness of the R21\u002FMatrix-M Malaria Vaccine in Children in Burkina Faso and Uganda","AVERT","Inclusion Criteria:\n\n* Residence in an area where R21\u002FMatrix-M is implemented and within the catchment area of a selected study facility.\n* Younger than 5 years and eligibleto receive R21\u002FMatrix-M under the national vaccination schedule at rollout.\n* Meets the country definition of suspected malaria, generally axillary temperature of at least 37.5 degrees Celsius or a history of fever within the previous 24 hours, and is undergoing malaria testing.\n* Written informed consent provided by an adult caregiver aged 18 years or older.\n\nExclusion Criteria:\n\n* Caregiver is unable or unwilling to provide informed consent.\n* Severe non-malaria illness at presentation that would interfere with study participation.\n* Repeat presentation within the protocol-defined exclusion window after a previous enrollment: within 14 days after a microscopy-positive visit; or more than 7 but fewer than 14 days after a microscopy-negative visit. A microscopy-negative visit followed by a positive diagnosis within 7 days will be reclassified as positive rather than treated as a new enrollment.\n* Documented receipt of any RTS,S malaria vaccine dose.","5 Months","5 Years",{"count":527,"type":23},20000,"The AVERT study is a prospective observational test-negative case control study evaluating the real-world effectiveness of the R21\u002FMatrix-M malaria vaccine among children younger than 5 years in Burkina Faso and Uganda. Children who seek outpatient care with suspected malaria and are eligible for the national R21\u002FMatrix-M vaccination program will be enrolled. Malaria infection will be determined by blood smear microscopy. Children with a positive microscopy result will be classified as cases and children with a negative result as controls. Vaccination history, including the number and timing of doses, will be obtained primarily from vaccination cards or other written records. Vaccine effectiveness will be estimated by comparing the odds of vaccination among cases and controls.",[333,530],"PLASMODIUM FALCIPARUM MALARIA",[532,533,534,535,536,537,538,539],"R21\u002FMatrix-M","Malaria vaccine","Vaccine effectiveness","Test-negative design","Clinical malaria","Children","Burkina Faso","Uganda","2026-08-03",{"date":488,"type":35},{"date":543,"type":35},"2026-07-14",{"date":545,"type":23},"2027-08",{"name":547,"class":90},"Clinton Health Access Initiative Inc.",21,{"id":550,"slug":551,"hasResults":12,"nctId":552,"briefTitle":553,"officialTitle":553,"acronym":4,"eligibilityCriteria":554,"healthyVolunteers":12,"sex":52,"minAge":53,"maxAge":4,"enrollmentInfo":555,"targetDuration":4,"studyType":24,"phases":557,"briefSummary":558,"conditions":559,"keywords":564,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":576,"lastUpdatePostDateStruct":577,"startDateStruct":578,"completionDateStruct":579,"leadSponsor":581,"locationsCount":91},"100650292","phase-3-optimizing-care-for-cryptococcal-antigenemia-evaluation-of-short-course-fluconazole-and-art-timing-among-crag-persons-with-low-titers-100650292","NCT07743593","Optimizing Care for Cryptococcal Antigenemia: Evaluation of Short Course Fluconazole and ART Timing Among CrAg+ Persons With Low Titers","Inclusion Criteria:\n\n* HIV-1 infection\n* Age greater than 18 years\n* Ability and willingness to give informed consent\n* Plasma or serum cryptococcal antigen positive with titer less than 1:160\n\nExclusion Criteria:\n\n* Cannot or unlikely to attend regular clinic visits\n* History of cryptococcal infection\n* Symptomatic meningitis confirmed by cerebrospinal fluid cryptococcal antigen positivity\n* More than 10 weeks of fluconazole therapy\n* Pregnancy confirmed by urinary or serum pregnancy test\n* Current breastfeeding",{"count":556,"type":23},505,[26],"This randomized clinical trial will evaluate the optimal duration of fluconazole therapy and timing of antiretroviral therapy initiation among HIV-infected persons with asymptomatic cryptococcal antigenemia and low cryptococcal antigen titers in Uganda.\n\nParticipants with low-titer cryptococcal antigenemia will be followed to assess whether a shorter 10-week course of fluconazole is non-inferior to the standard 24-week fluconazole regimen for 24-week cryptococcal meningitis-free survival. Among participants eligible for antiretroviral therapy timing randomization, the study will also compare immediate antiretroviral therapy initiation with delayed initiation after 14 days to evaluate 10-week hospitalization-free survival.\n\nParticipants will be followed for up to 24 weeks, with study visits and contacts to assess survival, cryptococcal meningitis, hospitalizations, adverse events, and fluconazole adherence.",[560,561,562,563],"Cryptococcal Antigenemia","HIV-1-infection","Cryptococcal Infection","Cryptococcal Meningitis",[565,566,567,568,569,570,571,572,573,539,574,575],"Cryptococcal antigen","CrAg","Fluconazole","Fluconazole Short-course fluconazole","Low CrAg titer","Immediate ART","Advanced HIV disease","Cryptococcal meningitis-free survival","Hospitalization-free survival","ART initiation","Antiretroviral therapy","2026-07-30",{"date":486,"type":35},{"date":490,"type":23},{"date":580,"type":23},"2031-08-30",{"name":582,"class":90},"University of Minnesota",{"id":584,"slug":585,"hasResults":12,"nctId":586,"briefTitle":587,"officialTitle":588,"acronym":4,"eligibilityCriteria":589,"healthyVolunteers":12,"sex":52,"minAge":53,"maxAge":4,"enrollmentInfo":590,"targetDuration":4,"studyType":24,"phases":592,"briefSummary":593,"conditions":594,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":597,"lastUpdatePostDateStruct":598,"startDateStruct":599,"completionDateStruct":600,"leadSponsor":602,"locationsCount":416},"100610453","phase-2-b-palmz-for-tb-meningitis-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":591,"type":23},240,[203],"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.",[595,109,81,596],"Tuberculous Meningitis","TB - Tuberculosis","2026-07-28",{"date":576,"type":35},{"date":597,"type":35},{"date":601,"type":23},"2030-09-30",{"name":603,"class":90},"David Boulware",{"id":605,"slug":606,"hasResults":12,"nctId":607,"briefTitle":608,"officialTitle":609,"acronym":4,"eligibilityCriteria":610,"healthyVolunteers":12,"sex":52,"minAge":53,"maxAge":4,"enrollmentInfo":611,"targetDuration":4,"studyType":504,"phases":4,"briefSummary":613,"conditions":614,"keywords":617,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":619,"lastUpdatePostDateStruct":620,"startDateStruct":621,"completionDateStruct":623,"leadSponsor":624,"locationsCount":91},"100649125","disclosure-social-harm-and-support-activation-study-100649125","NCT07730307","Disclosure, Social Harm, and Support Activation Study","Disclosure, Social Harm, and Support Activation Study:How Disclosure of Suicidality and Severe Emotional Distress Functions Socially in Rural Eastern Uganda","Inclusion Criteria:\n\n* Meets at least one of the following:\n\n  1. self-reports a history of suicidal ideation or attempt,\n  2. self-reports a period of severe depressive distress (persistent sadness, hopelessness, withdrawal lasting ≥2 weeks), or\n  3. has previously disclosed suicidal thoughts or severe distress to another person\n* Able and willing to provide informed consent\n\nExclusion Criteria:\n\n* Currently in acute suicidal crisis with intent or plan (activate safeguarding protocol, defer enrollment to after stabilization)\n* Unable to engage in a 25-30 minute survey without significant distress",{"count":612,"type":23},361,"To characterize how disclosure of suicide or severe emotional distress functions socially in rural eastern Uganda: who people have disclosed to, what happened, what harms resulted, who they would want involved in future support, and under what conditions they would want support activated on their behalf.",[615,616],"Mental Illness","Suicidal",[618],"suicide disclosure","2026-07-23",{"date":597,"type":35},{"date":622,"type":35},"2026-05-25",{"date":187,"type":23},{"name":120,"class":90},{"id":626,"slug":627,"hasResults":12,"nctId":628,"briefTitle":629,"officialTitle":630,"acronym":631,"eligibilityCriteria":632,"healthyVolunteers":12,"sex":52,"minAge":53,"maxAge":4,"enrollmentInfo":633,"targetDuration":4,"studyType":24,"phases":635,"briefSummary":636,"conditions":637,"keywords":639,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":619,"lastUpdatePostDateStruct":641,"startDateStruct":643,"completionDateStruct":645,"leadSponsor":647,"locationsCount":416},"100567294","phase-2-platform-trial-for-cryptococcal-meningitis-platform-cm-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":634,"type":23},2000,[203,26],"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.\n\nAs multiple new antifungal medicines are on the horizon, this platform trial utilizes a master protocol to investigate, multiple antifungal regimens using standardized eligibility criteria, standardized study schedule of events, and standardized contemporary endpoints.",[638,563],"Hiv",[640],"cryptococcus",{"date":642,"type":35},"2026-07-27",{"date":644,"type":35},"2025-05-28",{"date":646,"type":23},"2032-04-21",{"name":603,"class":90},{"id":649,"slug":650,"hasResults":12,"nctId":651,"briefTitle":652,"officialTitle":653,"acronym":4,"eligibilityCriteria":654,"healthyVolunteers":17,"sex":52,"minAge":199,"maxAge":655,"enrollmentInfo":656,"targetDuration":4,"studyType":24,"phases":658,"briefSummary":659,"conditions":660,"keywords":664,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":671,"lastUpdatePostDateStruct":672,"startDateStruct":673,"completionDateStruct":674,"leadSponsor":676,"locationsCount":91},"100649070","pnf-rct-to-decrease-alcohol-use-and-increase-hiv-prevention-100649070","NCT07731932","PNF RCT to Decrease Alcohol Use and Increase HIV Prevention","Personalized Normative Feedback to Decrease Unhealthy Alcohol Use and Increase HIV Prevention Behavior Among Youth and Young Adults in Rural Ugandan Schools","Inclusion Criteria:\n\n* All students enrolled in Kinoni High School, Kinoni Girls Secondary School, or Rugando Technical Institute, 13-25 years of age\n\nExclusion Criteria:\n\n* Persons with psychosis, neurological damage, acute intoxication, or other cognitive impairment (all of which are determined informally in the field by non-clinical research staff in consultation with a supervisor)","25 Years",{"count":657,"type":23},1350,[78],"Randomized controlled trial to test the preliminary efficacy and mediating mechanism of a personalized normative feedback intervention on behavioral intentions, heavy alcohol use, and HIV\u002FSTI prevention among adolescents and young adults in Rwampara District, Uganda.",[661,662,663],"HIV (Human Immunodeficiency Virus)","Alcohol Misuse","STI",[665,666,667,668,669,670],"HIV transmission","sexually transmitted infections","personalized normative feedback","social norms","HIV prevention","alcohol use","2026-07-22",{"date":597,"type":35},{"date":490,"type":23},{"date":675,"type":23},"2030-08-30",{"name":677,"class":90},"Vanderbilt University",""]