[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Haiti\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":176},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,49,72,95,118,146],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100641915","phase-2-a-trial-of-stratified-patient-centered-treatment-regimens-for-active-tb-spectra-tb-100641915",false,"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.","ALL","13 Years",{"count":19,"type":20},900,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26],"Tuberculosis",[26,28,29,30,31,32,33,34,35],"Pulmonary tuberculosis","Drug-susceptible tuberculosis","Rifampin-susceptible tuberculosis","Rifapentine","Moxifloxacin","HIV coinfection","Treatment shortening","Risk-stratified treatment","NOT_YET_RECRUITING","2026-08-17",{"date":39,"type":40},"2026-08-19","ACTUAL",{"date":42,"type":20},"2026-10-30",{"date":44,"type":20},"2029-10-22",{"name":46,"class":47},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",29,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":17,"enrollmentInfo":56,"targetDuration":4,"studyType":21,"phases":58,"briefSummary":60,"conditions":61,"keywords":62,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":65,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},"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":57,"type":20},144,[59,23],"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.",[26],[63,26,64],"HIV","Latent Tuberculosis",{"date":39,"type":40},{"date":67,"type":20},"2026-10-15",{"date":69,"type":20},"2028-05-31",{"name":46,"class":47},11,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":80,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":21,"phases":83,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":48},"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.","18 Years",{"count":82,"type":20},315,[23],"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.",[86],"Pulmonary Tuberculosis","RECRUITING",{"date":89,"type":40},"2026-08-18",{"date":91,"type":40},"2025-03-11",{"date":93,"type":20},"2027-08-11",{"name":46,"class":47},{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":102,"enrollmentInfo":103,"targetDuration":4,"studyType":21,"phases":105,"briefSummary":106,"conditions":107,"keywords":109,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":111,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},"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":104,"type":20},1120,[59,23],"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.",[108],"HIV Infection",[110],"HIV Remission",{"date":39,"type":40},{"date":113,"type":40},"2015-01-23",{"date":115,"type":20},"2031-12-31",{"name":46,"class":47},46,{"id":119,"slug":120,"hasResults":11,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":124,"eligibilityCriteria":125,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":126,"targetDuration":4,"studyType":21,"phases":128,"briefSummary":130,"conditions":131,"keywords":132,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":145},"100322140","phase-2-assessment-of-the-safety-tolerability-and-effectiveness-of-rifapentine-given-daily-for-ltbi-100322140","NCT03474029","Assessment of the Safety, Tolerability, and Effectiveness of Rifapentine Given Daily for LTBI","Six Weeks of Daily Rifapentine vs. a Comparator Arm of 12-16 Week Rifamycin-based Treatment of Latent M. Tuberculosis Infection: Assessment of Safety, Tolerability and Effectiveness","ASTERoiD","Inclusion Criteria\n\n1. Persons with LTBI who do not have evidence of TB disease (see exclusion criteria) and are at increased risk of progression to TB. LTBI or M. tuberculosis infection may be demonstrated by either a positive tuberculin skin test (TST) or a positive interferon gamma release assay (IGRA; e.g., QuantiFERON or T.SPOT.TB). Details of testing definitions and requirements for each risk factor are further described in the MOOP. Persons with LTBI at increased risk of progression to TB are those with at least one of the following:\n\n   1. Household and other close contacts (\\> 4 hours of exposure in a one-week period) within 2 years prior to enrollment, of persons with bacteriologically confirmed TB.\n\n      o Acceptable testing approaches for bacteriologic confirmation are 1) culture with rifamycin DST; or, 2) nucleic acid amplification tests (NAATs) that detect M. tuberculosis and detect mutations associated with rifamycin resistance. Additional details on bacteriologic confirmation, including accepted NAATs, will be included in the MOOP.\n   2. Recent M. tuberculosis infection, defined as converting from a documented negative to positive TST or IGRA within 2 years prior to enrollment. Persons without known close contact to someone with active pulmonary TB who have a conversion by IGRA may require additional evaluation to rule out a false conversion. Additional guidance and definitions of conversion are in the MOOP.\n   3. HIV co-infection (with CD4+ T-lymphocyte count \\> 100 cells\u002Fmm3)\n   4. ≥ 2 cm2 of pulmonary parenchymal fibrosis on chest X-ray and no prior history of treatment for TB or LTBI.\n   5. Recent (within 3 years prior to enrollment) immigration to the United States or other country with low to moderate TB incidence, with abnormal chest X-ray, and no evidence of active TB.\n   6. Recent (within 3 years prior to enrollment) immigration to the United States or other country with low to moderate TB incidence, from a country with an estimated incidence rate of TB \\> 150 per 100,000 (see Appendix D) and either a positive IGRA or a TST ≥15 mm (TST \\> 15 mm only applicable for those with recent immigration as their only risk factor for progression to TB).\n   7. Recent (within 3 years prior to enrollment) immigration and seeking refugee\u002Fasylum status (see MOOP for additional details) to the United States or other country with low to moderate incidence from a country with an estimated incidence rate of TB \\> 75 per 100,000 (see Appendix E) and either a positive IGRA or a TST ≥15 mm (TST \\> 15 mm only applicable for those with recent immigration as their only risk factor for progression to TB).\n   8. Individuals with an increased risk of TB due to medical conditions such as end-stage renal disease.\n   9. Individuals currently using immunosuppressive medications such as chronic steroids.\n   10. Individuals with planned use of TNF-α inhibitors.\n   11. Individuals with planned solid organ or hematologic transplantation\n2. Willing to provide signed informed consent, or parental permission and participant assent.\n3. For the following special populations, both inclusion criteria above must be met AND the criteria below depending on stage:\n\n   1. Pregnant women in their second or third trimester (≥14 weeks gestation).\n\n      * Stage 1: Include only those who agree to participate in the semi-intensive PK component.\n      * Stage 2: Include regardless of semi-intensive PK component participation.\n   2. Children aged less than 12 years\n\n      * Stage 1: Include only those who agree to participate in the semi-intensive PK component, based on enrollment strategy presented in Appendix I.\n      * Stage 2: Include regardless of semi-intensive PK component participation, based on PK findings and enrollment strategy described in Appendix I.\n\nExclusion Criteria\n\n1. Failure to document positive IGRA or TST\n2. Current breastfeeding.\n3. Women who are currently pregnant in their first trimester (\\\u003C14 weeks gestation) or intend to become pregnant within 120 days of enrollment.\n4. Non-pregnant women of childbearing potential who refuse to practice an adequate method of contraception (barrier method or non-hormonal intrauterine device) or abstain from activities that could lead to pregnancy.\n5. Current culture-positive TB, clinical TB, or suspected current TB. (Includes cases in which active TB cannot be excluded with reasonable clinical certainty by the site investigator. If sputum samples have been collected AND site investigators have suspicion of active TB, site investigators must wait to review culture results prior to enrollment.)\n6. TB resistant to any rifamycin in the source case\n7. A history of treatment for \\> 7 consecutive days (if daily dosing) with a rifamycin or \\>1 week (if weekly dosing) with a rifamycin and INH or \\> 30 consecutive days with INH within 2 years prior to enrollment.\n8. A documented history of completing an adequate course of treatment for TB disease or LTBI in a person who is HIV-seronegative.\n9. History of allergy or intolerance to rifamycins.\n10. Serum alanine aminotransferase (ALT; SGPT) or serum aspartate aminotransferase (AST; SGOT) \\> 5x upper limit of normal among persons in whom screening ALT or AST is determined.\n11. Receiving concomitant medications that are known to be contraindicated with any study drug.\n12. Weight \\\u003C 25 kg for participants ≥ 12 years, and weight \\\u003C 3kg for participants \\\u003C 12 years",{"count":127,"type":20},3400,[23,129],"PHASE3","This study is conducted to compare the safety and effectiveness of a novel short 6-week regimen of daily rifapentine (6wP, experimental arm) with a comparator arm of 12-16 weeks of rifamycin-based treatment (standard of care, control arm) of latent M. tuberculosis infection (LTBI).\n\nThis trial is conducted among persons who are at increased risk of progression to tuberculosis (TB) and require treatment of LTBI. The study will be conducted in low, medium and high TB incidence settings that have treatment of LTBI as their standard of care and offer 12-16 week rifamycin-based therapy as standard of care.\n\nThe hypothesis of this study is that the safety and effectiveness of the experimental treatment (6wP arm) is non-inferior to a comparator arm of 12-16 weeks of rifamycin-based treatment of LTBI (control arm).\n\nParticipants are enrolled and randomly assigned to one of the two study arms: experimental 6wP or control. The comparator (control) arm's treatment regimens include 12 weeks of once-weekly isoniazid (INH) and rifapentine (3HP), 12 weeks of daily INH and rifampin (3HR), and 16 weeks of daily rifampin (4R). A total of 560 participants per arm (1,120 total) for the evaluation of safety and 1,700 participants per arm (3,400 total) for the evaluation of effectiveness will be enrolled, given treatment as per randomization assignment, and followed for 24 months from the date of enrollment.\n\nAfter completion of data collection, statistical analyses will be conducted to compare proportions of drug discontinuation due to adverse drug reaction (ADR) and proportions of newly diagnosed tuberculosis between 6wP and control arm.",[64],[133,134],"latent tuberculosis","rifapentine","2026-05-04",{"date":137,"type":40},"2026-05-06",{"date":139,"type":40},"2019-08-01",{"date":141,"type":20},"2029-12-31",{"name":143,"class":144},"Centers for Disease Control and Prevention","FED",21,{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":152,"eligibilityCriteria":153,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":154,"enrollmentInfo":155,"targetDuration":4,"studyType":21,"phases":157,"briefSummary":159,"conditions":160,"keywords":163,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":175},"100476207","improving-nighttime-access-to-care-and-treatment-part-4-haiti-100476207","NCT05480930","Improving Nighttime Access to Care and Treatment; Part 4-Haiti","Novel Approach to Improve Patient Care and Diarrheal Disease Research Using Mobile Technology in Haiti","INACT4-H","Inclusion criteria for child, parent\u002Fguardian participants:\n\n* Children 10 years of age or younger with an acute illness\n* Parent\u002Fguardian contacts the TMDS in regards to the illness during hours of operation\n* Parental\u002Fguardian agreement to a waiver of documentation of consent when contact is by phone only OR written consent\u002Fassent at the household from the parent\u002Fguardian and child (7yrs and older) for participants who receive a household visit.\n\nExclusion criteria for child, parent\u002Fguardian participants:\n\n* No consent","10 Years",{"count":156,"type":20},7124,[158],"NA","Children in resource-limited settings who develop illness at night are often isolated from care, resulting in progression to an emergency. A telemedicine and medication delivery service (TMDS) is a viable healthcare delivery option to bridge the gap in nighttime care. This interrupted time series study (pre\u002Fpost) will evaluate a digital clinical decision-support (dCDS) tool. The objective is to assess if the tool is associated with an improvement in guideline adherence by TMDS providers.",[161,162],"Telemedicine","Pediatrics",[164],"digital clinical decision support","2025-06-26",{"date":167,"type":40},"2025-06-30",{"date":169,"type":40},"2022-09-27",{"date":171,"type":20},"2027-09",{"name":173,"class":174},"University of Florida","OTHER",1,""]