[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100324935":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":43,"centralContacts":35,"locations":47,"responsibleParty":61,"collaborators":35,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":35,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":35,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":88,"whyStopped":35,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"National Institutes of Health Clinical Center (CC)","NIH",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Pharmacokinetic study in healthy volunteers","EXPERIMENTAL","Healthy volunteers received Tenofovir alafenamide (TAF) 25 mg once daily for 14 days followed by TAF 25 mg once daily and Rifapentine (RPT) dosed by weight in 150-mg tablet increments (maximum oral dose of 900 mg) 750 or 900 mg (depending on weight) and Isoniazid (INH+ pyridoxine), 15 mg\u002Fkg (up to 900 mg) once weekly from days 15-31.",[13,14,15,16],"Drug: Tenofovir alafenamide","Drug: Rifapentine","Drug: Isoniazid (INH)","Dietary Supplement: Pyridoxine",[18,25,31,36],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DRUG","Tenofovir alafenamide","Each tablet contains 25 mg of tenofovir alafenamide.",[9],[24],"Vemlidy",{"type":19,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"Rifapentine","Each tablet contains 150 mg of rifapentine. Participants who weigh 45 to \\\u003C 50 kg will take 750 mg (5 tablets), and participants who weigh (Bullet) 50 kg will take 900 mg (6 tablets).",[9],[30],"Priftin",{"type":19,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"Isoniazid (INH)","Each tablet is formulated as 100 or 300 mg of isoniazid.",[9],null,{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"DIETARY_SUPPLEMENT","Pyridoxine","Each tablet contains 50 mg of pyridoxine",[9],[42],"Vitamin B6",[44],{"name":45,"affiliation":5,"role":46},"Joseph A Kovacs, M.D.","PRINCIPAL_INVESTIGATOR",[48],{"facility":49,"status":35,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":35},"National Institutes of Health Clinical Center","Bethesda","Maryland","20892","United States","US",{"type":56,"coordinates":57},"Point",[58,59],-77.10026,38.98067,{"lat":59,"lon":58},{"type":62,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","100324935","phase-1-impact-of-weekly-administration-of-rifapentine-and-isoniazid-on-steady-state-pharmacokinetics-of-tenofovir-alafenamide-in-healthy-volunteers-yoda-100324935",true,"NCT03510468","Impact of Weekly Administration of Rifapentine and Isoniazid on Steady State Pharmacokinetics of Tenofovir Alafenamide in Healthy Volunteers (YODA)","Impact of Weekly Administration of Rifapentine and Isoniazid on Steady State Pharmacokinetics of Tenofovir Alafenamide in Healthy Volunteers","* PARTICIPANT INCLUSION CRITERIA:\n\nIndividuals must meet all of the following criteria to be eligible for study participation:\n\n1. Ages 18-65 years.\n2. Weight greater than or equal to 45 kg and less than or equal to 120 kg OR body mass index greater than or equal to 18.0 and \\\u003C 30.\n3. Judged to be healthy based on medical history, physical examination, vital signs, and clinical laboratory tests: liver function tests (AST, alanine transaminase( ALT), Tbili) less than or equal to upper limit of normal \\[ULN\\], serum creatinine (SCr) less than or equal to ULN, platelets (PLT) \\> 150,000\u002FmicroL, hemoglobin (Hgb) \\> 13 g\u002FdL (males); greater than or equal to 12g\u002FdL (females), C-reactive protein (CRP) less than or equal to ULN, creatine kinase (CK) less than or equal to 2x ULN, fasting total cholesterol \\\u003C 240 mg\u002FdL, or fasting triglycerides \\\u003C 240 mg\u002FdL, urine glucose \\\u003C grade 2 (per Division of Acquired Immunodeficiency Syndrome (DAIDS) adverse event (AE) table), urine protein \\\u003C grade 2 (per DAIDS AE table).\n4. Negative QuantiFERON-TB Gold test at screening.\n5. HIV-negative, as determined by standard serologic assays for HIV infection.\n6. No laboratory evidence of active or chronic hepatitis A, B, or C infection.\n7. Willing to abstain from alcohol consumption throughout the study period.\n8. Agrees to genetic testing and storage of specimens for future research.\n9. Able to provide informed consent.\n10. Negative serum or urine pregnancy test for females of child-bearing potential.\n11. Participants must agree not to become pregnant or impregnate a partner for the duration of the study. The use of hormonal contraceptives will not be permitted. Study participants must use one of the following methods of birth control when engaging in sexual activities that can result in pregnancy, beginning at screening until the final study visit.\n\n    1. Male or female condom.\n    2. Diaphragm or cervical cap with a spermicide.\n    3. Intrauterine device without hormones.\n\nPARTICIPANT EXCLUSION CRITERIA:\n\nIndividuals meeting any of the following criteria will be excluded from study participation:\n\n1. Known hypersensitivity to TAF, tenofovir disoproxil fumarate (TDF), INH, RPT, and other rifamycin analogues.\n2. History or presence of any of the following:\n\n   1. Latent or active TB infection.\n   2. Gastrointestinal (GI) disease that is uncontrolled, requires daily treatment with medication, or would interfere with a participant s ability to absorb drugs (eg, diarrhea, pancreatitis, or peptic ulcer disease).\n   3. Renal impairment (chronic renal insufficiency of any chronic kidney disease stage, or acute renal failure not induced by drug therapy defined as estimated glomerular filtration rate (eGFR) \\\u003C 90 mL\u002Fmin or SCr \\> ULN).\n   4. Respiratory disease that is uncontrolled or requires daily treatment with medication (eg, asthma or chronic obstructive pulmonary disease).\n   5. Cardiovascular disease (eg, hypertension \\[systolic blood pressure \\> 140 mm Hg or diastolic blood pressure \\> 90 mm Hg\\], heart failure, or arrhythmia).\n   6. Metabolic disorders (eg, diabetes mellitus).\n   7. Hematologic or bleeding disorders (eg, anemia, hemophilia, serious\u002Fmajor bleeding events, menorrhagia \\[female participants\\]).\n   8. Immunologic disorders.\n   9. Hormonal or endocrine disorders.\n   10. Psychiatric illness that would interfere with their ability to comply with study procedures or that requires daily treatment with medication.\n   11. Seizure disorder, with the exception of childhood febrile seizures.\n   12. Any current or history of malignancy, with the exception of cutaneous basal cell carcinoma,non-invasive squamous cell carcinoma, or any other malignancies not requiring systemic\n\n       therapy.\n   13. Current or history of osteopenia and osteoporosis.\n3. Current participation in an ongoing investigational drug protocol or use of any investigational drug within 30 days (based on last dose received) prior to receipt of any study drugs.\n4. Therapy with any prescription, over-the-counter (OTC), herbal, or holistic medications, including hormonal contraceptives by any route, within 5 half-lives of the agent prior to receipt of any study medications will not be permitted with the following exception: Intermittent or short-course therapy (\\\u003C14 days) with prescription or OTC medications, herbals, or holistic medications within the screening period prior to starting study drugs may be permitted, and will be reviewed by investigators on a case-by-case basis for potential drug interactions. Receipt of influenza vaccination will be allowed prior to, during, and\u002For after the study.\n5. Inability to obtain venous access for sample collection.\n6. Inability to swallow whole capsules and\u002For tablets.\n7. Pregnant or breastfeeding.\n8. Drug use that may impair safety or adherence.\n9. Use of nicotine-containing products, including cigarettes and chewing tobacco, nicotine patches, gum, electronic cigarettes, etc.\n10. Organ or stem cell transplant recipient.\n11. Uncorrected and persistent electrolyte abnormalities (eg, potassium, magnesium, and calcium).\n12. Current alcohol use disorders (DSM-5 criteria).\n13. Fasting total cholesterol \\> 240 mg\u002FdL or fasting triglycerides \\> 240 mg\u002FdL at screening.\n14. Any condition that, in the opinion of the investigator, contraindicates participation in this study.","ALL","18 Years","65 Years",{"count":74,"type":75},51,"ACTUAL","INTERVENTIONAL",[78],"PHASE1","Background:\n\nHuman immunodeficiency virus (HIV) is treated with antiretroviral drugs. Many people with HIV also have the lung infection tuberculosis (TB). Most TB treatments are complicated. A simpler treatment of two TB drugs can be taken once a week. Researchers want to study how the HIV and TB drugs affect each other so people who take both can be treated safely.\n\nObjective:\n\nTo study if rifapentine and isoniazid affect blood levels of the common antiretroviral TAF.\n\nEligibility:\n\nHealthy adults ages 18-65 without HIV, TB, or hepatitis\n\nDesign:\n\nParticipants will fast before the screening visit. They will have a medical history, physical exam, and blood tests. Women may have a pregnancy test.\n\nDuring the study, participants must:\n\nUse effective birth control\n\nNot take most medicine\n\nNot drink alcohol\n\nAt the baseline visit, participants will repeat screening tests and get TAF tablets.\n\nParticipants will take TAF once a day for 31 days. They will keep track of doses and side effects.\n\nOver 32 days, participants will have 4 long visits and 4 short.\n\nAt all visits, participants will:\n\nFast the night before\n\nGet food\n\nTake that day's TAF\n\nReview their TAF supply\n\nHave pregnancy and blood tests\n\nReport side effects\n\nAt 3 visits, participants will also take the 2 TB drugs and vitamin B6.\n\nAt 3 long visits, participants will also have blood collected 8 times over 8 hours by plastic tube in an arm vein.\n\nAround Day 46, participants will fast and have blood and pregnancy tests. Two weeks later, they will get a call to see how they are feeling.",[81],"Healthy Volunteers",[83,84,85,86,87],"Antiretroviral Therapy","Human Immunodeficiency Virus","Latent Tuberculosis","Drug-Drug Interactions","Rifamycin","COMPLETED","2024-07-17",{"date":91,"type":75},"2024-08-13",{"date":93,"type":75},"2018-06-12",{"date":95,"type":75},"2022-12-21",{"name":5,"class":6},1]