[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100395068":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":37,"centralContacts":42,"locations":43,"responsibleParty":62,"collaborators":66,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":42,"enrollmentInfo":78,"targetDuration":42,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":88,"overallStatus":93,"whyStopped":42,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"University of Witwatersrand, South Africa","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Tenofovir Alafenamide","EXPERIMENTAL","TAF 25 mg once-daily administered with RIF\u002FINH 600\\*\u002F300mg",[13,14,15],"Drug: Phase 1: Tenofovir disoproxil fumarate\u002FEmtricitabine\u002FEfavirenz coadministered with Rifampicin\u002FIsoniazid","Drug: Phase 2: Tenofovir alafenamide\u002FLamivudine\u002FEfavirenz coadministered with Rifampicin\u002FIsoniazid","Drug: Phase 3: Tenofovir disoproxil fumarate\u002FEmtricitabine\u002FEfavirenz",[17,25,32],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"DRUG","Phase 1: Tenofovir disoproxil fumarate\u002FEmtricitabine\u002FEfavirenz coadministered with Rifampicin\u002FIsoniazid","TDF\u002FFTC\u002FEFV 300\u002F200\u002F600 mg once daily plus RIF\u002FINH 600\\*\u002F300 mg daily from screening until enrolment (days -15 to 0)",[9],[23,24],"Atripla","Rifinah",{"type":18,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"Phase 2: Tenofovir alafenamide\u002FLamivudine\u002FEfavirenz coadministered with Rifampicin\u002FIsoniazid","TAF 25 mg + 3TC 300 mg + EFV 600 mg once daily plus RIF\u002FINH 600\u002F\\*300 mg daily (days 1 to ≤ 56)",[9],[30,31],"HepBest","Stocrin",{"type":18,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"Phase 3: Tenofovir disoproxil fumarate\u002FEmtricitabine\u002FEfavirenz","TDF\u002FFTC\u002FEFV 300\u002F200\u002F600 mg once daily. RIF\u002FINH 600mg \\\u003C70kg, 750mg \\>70kg",[9],[23,24],[38],{"name":39,"affiliation":40,"role":41},"Simiso Sokhela, MBBCh","Ezintsha, a subdivision of Wits Reproductive Health and HIV Institute (Wits RHI)","PRINCIPAL_INVESTIGATOR",null,[44,57],{"facility":45,"status":42,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":42},"Charlotte Maxeke Johannesburg Academic Hospital","Johannesburg","Gauteng","2196","South Africa","ZA",{"type":52,"coordinates":53},"Point",[54,55],28.04363,-26.20227,{"lat":55,"lon":54},{"facility":58,"status":42,"city":46,"state":47,"zip":42,"country":49,"countryCode":50,"cosmosGeoPoint":59,"geoPoint":61,"contacts":42},"Wits RHI Yeoville Clinic",{"type":52,"coordinates":60},[54,55],{"lat":55,"lon":54},{"type":63,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":42,"oldOrganization":42},"SPONSOR_INVESTIGATOR","Professor Francois Venter","Divisional Director of Ezintsha",[67],{"name":68,"class":6},"University of Cape Town","100395068","phase-1-the-effect-of-rifampicin-on-the-pharmacokinetics-of-intracellular-tenofovir-diphosphate-and-tenofovir-when-coadministered-with-tenofovir-alafenamide-fumarate-during-the-maintenance-phase-of-tuberculosis-treatment-in-tbhiv-1-coinfected-participants-100395068",false,"NCT04424264","The Effect of Rifampicin on the Pharmacokinetics of Intracellular Tenofovir-diphosphate and Tenofovir When Coadministered With Tenofovir Alafenamide Fumarate During the Maintenance Phase of Tuberculosis Treatment in TB\u002FHIV-1 Coinfected Participants","EpiTAF","Inclusion Criteria:\n\n1. Adult (≥ 18 years old) male or female\n2. HIV-1 infected on TDF\u002FFTC\u002FEFV with HIV RNA \\\u003C 50 copies\u002FmL in the last three months\n3. On TB treatment in the maintenance phase (RIF\u002FINH) with at least one month of TB treatment needed for completion\n4. Women of childbearing potential must not be pregnant or breastfeeding, with a negative pregnancy test at screening\n5. Women must be postmenopausal, surgically sterile or practicing an effective birth control method (established before and maintained throughout the trial). Women who are not sexually active must agree to use an effective birth control method if they become heterosexually active during the trial\n6. Understand the purpose of and procedures required for the study and having confirmed they are willing to participate in the study by signing the informed consent document.\n\nExclusion Criteria:\n\n1. Weight \\\u003C 40 kg\n2. Estimated creatinine clearance \\\u003C 50 mL\u002Fmin\n3. Any active clinically significant or life-threatening disease (e.g. acute infections, pancreatitis, hepatitis, cardiac dysfunction), medical or psychiatric condition, or findings during screening, that in the investigator's opinion would compromise the safety of the participant or the study outcome, or their ability to comply with the study procedures\n4. Chronic medical requirement for any drugs that are known to affect the PK of the study drugs\n5. Active drug\u002Falcohol abuser\n6. History of allergy or hypersensivity to any of the study drugs\n7. Currently enrolled in an investigational drug study or has participated in an investigational drug study within the 4 weeks before screening\n8. Unable to comply with study protocol and study protocol restrictions","ALL","18 Years",{"count":79,"type":80},18,"ACTUAL","INTERVENTIONAL",[83],"PHASE1","This is a pharmacokinetic study investigating the effect of rifampicin on the pharmacokinetics of intracellular tenofovir-diphosphate and plasma tenofovir when coadministered with tenofovir alafenamide fumarate during the maintenance phase of tuberculosis treatment in TB\u002FHIV-1 coinfected participants (EpiTAF)",[86,87],"HIV-1-infection","Tuberculosis",[89,90,91,92],"Rifampicin, RIF\u002FINH","Tenofovir alafenamide fumarate (TAF)","Pharmacokinetics","Intracellular tenofovir-diphosphate","COMPLETED","2022-06-06",{"date":96,"type":80},"2022-06-07",{"date":98,"type":80},"2019-12-05",{"date":100,"type":80},"2020-10-30",{"name":64,"class":6},2]