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Tuberculosis Trials Consortium (TBTC)										Related Pages
										**Completed and Ongoing TBTC Studies**
Completed and Ongoing TBTC Studies
Study
Title
Status
ReferencesStudy 36
Platform for Assessment of TB Treatment Outcomes
An Observational Study of Individuals
Treated for Pulmonary Tuberculosis (TB)
EnrollingStudy 36A
Biobank Substudy:  An Observational Study of Individuals Treated for Pulmonary Tuberculosis (TB)
EnrollingStudy 35
Evaluation of RFPT PK in HIV-uninfected children 0-12 years of age
To begin Late 2016Study 34
A5295  Evaluation of Xpert MTB/RIF Assay for the Rapid Identification of TB and TB Rifampin Resistance in HIV-Infected and HIV-Uninfected Pulmonary Tuberculosis Suspects
CompletedStudy 33
An evaluation of adherence to LTBI treatment with 12 doses of once weekly rifapentine and isoniazid given as self-administered versus directly-observed therapy:
iAdhere
CompletedStudy 32
Prospective, Randomized, Blinded Phase 2 Pharmacokinetic/Pharmacodynamic Study of the Efficacy and Tolerability of Levofloxacin in Combination with Optimized Background Regimen (OBR) for the treatment of MDR-TB.  Acronym: “Opti-Q Study”
Began 2015; enrollingStudy 31
Rifapentine-containing treatment shortening regimens for pulmonary tuberculosis: A randomized, open-label, controlled phase 3 clinical trial.
To begin early 2015Study 30
Randomized, placebo-controlled, double-blind Phase I/II clinical trial assessing the safety and microbiological activity of Linezolid added to Optimized Background Therapy (OBT) for MDR TB or XDR TB.
Completed
IRB:Ethics & Human Research. 2011;33:10-17
Int J Tuberc Lung Dis 2012;16:1582-7Study 30PK
Substudy to characterize to characterize linezolid pharmacokinetic (PK) and linezolid time over the minimum inhibitory concentration (MIC) in patients with multi-drug resistant (MDR) and extensively-drug resistant (XDR) tuberculosis (TB).
CompletedStudy 29
Randomized, Phase II clinical trial assessing the antimicrobial activity and safety of substitution of rifapentine for rifampin in standard intensive phase TB treatment regimen.
Completed
J Infect Dis. 2012;206:1030-1040Study 29X
Enrollment complete in the main study. Study amended with extension to evaluate safety of higher rifapentine doses.
Completed
Published, AJRCCM 2015Study 29A
Phase 1 dose escalation of rifapentine in healthy volunteers (at Johns Hopkins)
Completed
Published AAC, 2015Study 29PK
Substudy to characterize rifapentine pharmacokinetic (PK) parameters in patients with TB.
Completed
Published AAC, 201529X Sparse Plus PK
TBTC Study PK-29X (sparse plus)
Pharmacokinetic and pharmacodynamic studies of efficacy, tolerability and safety of higher dosage rifapentine for treatment of tuberculosis.
CompletedStudy 29XPK
TBTC Study 29X PK (intensive sampling [7 samples over 24 hours] or sparse sampling [3 samples over 9 hours]
Pharmacokinetic and pharmacodynamic studies of efficacy, tolerability and safety of higher dosage rifapentine for treatment of tuberculosis.
(IRB Version 5 – Amendment to Study 29PK)
CompletedStudy 28
Randomized, double-blind, Phase II clinical trial assessing impact on 2-month sputum conversion rate of substitution of moxifloxacin for isoniazid in standard intensive phase TB treatment regimen.
Completed
AJRCCM 2009 Aug 1;180(3):273-80. Epub 2009 Apr 30
PLoS ONE 2011;6:e18358Study 27/28PK
Substudy to evaluates 1) the pharmacokinetics of moxifloxacin alone versus moxifloxacin administered with rifampin in healthy volunteers and 2) the pharmacokinetics of moxifloxacin and other TB drugs among patients with tuberculosis being treated with multidrug therapy, as well as genetic factors related to pharmacokinetic parameters and associations with markers of tuberculosis disease severity.
Completed
Antimi Agents Chemo 2007 Aug;51(8):2861-6
Epub 2007 May 21
Antimi Agents Chemo 2010 Jul 26. [Epub ahead of print]Study 27
Randomized, double-blind, Phase II clinical trial assessing impact on 2-month sputum conversion rate of substitution of moxifloxacin for ethambutol in standard intensive phase TB treatment regimen.
Completed
AJRCCM 2006; 174:331–338Study 26
Randomized, open-label Phase III clinical trial of ultra short-course treatment of latent TB infection among contacts of active cases, using a 3-month once-weekly regimen of isoniazid and rifapentine, compared to standard 9-month daily therapy with isoniazid.
Completed
N Engl J Med. 2011 Dec 8;365(23):2155-66
Int J Tuberc Lung Dis. 2013 Dec;17(12):1531-7
Morb Mort Wkly Rep 2011;60:1650-1653Study 26A
Sub-study of risk factors for hepatotoxicity in Study 26.
CompletedStudy 26HS
Substudy to examine the association between hypersensitivity syndrome and the presence of serum antibodies to isoniazid and/or rifapentine.
Enrollment CompletedStudy 26PK (Pediatric)
Substudy to determine if the pharmacokinetics of rifapentine exposure in children administered body-weight based dosing is equivalent to that in adults given 900 mg.
Completed
J Ped Infct Disea Soc Advn Access Pub Jan 16, 2014Study 25
Phase I-II dose escalation study of rifapentine using same design as Study 22, with patients completing 2-month standard induction randomized to 600, 900, and 1200 mg of once- weekly rifapentine/isoniazid.
Completed
Amer J Resp Crit Care Med 2002; 165: 1526-1530Study 25PK
Substudy to examine pharmacokinetics of rifapentine at each of 3 doses in patients who are participants in Study 25.
Completed
Am J Respir Crit Care Med 2004;169:1191-7NAA
Study of the performance of several nucleic acid amplification (NAA) methodologies in the diagnosis and management of active TB
Completed
(In press – Tuberculosis (Edinb) 2014)
(In press – Tuberculosis (Edinb) 2014)Study 24
Single-arm study of largely intermittent, short-course therapy for patients with INH-resistant TB or INH intolerance. Aims to enroll 200 patients over 2 years with 2 years of follow-up. Enrollment completed.
Completed
IJTLD, 2014 May 18(5)571-581Study 23
Single-arm clinical trial to evaluate the safety and efficacy of rifabutin-containing short-course therapy for HIV-infected TB patients receiving HIV protease inhibitors.
Completed
Am J Respir Crit Care Med 2006;173: 350-356
Int J Tuberc Lung Dis 2007;11:1282-9
Morb Mort Wkly Rep 202; 51:214-5Study 23a
Substudy to evaluate isoniazid and rifabutin pharmacokinetics in Study 23 TB patients with HIV receiving antiretroviral therapy.
Completed
Clinical Infectious Disease 2005;40:1481-91Study 23b
Substudy to evaluate rifabutin and nelfinavir pharmacokinetics in TB patients with HIV receiving nelfinavir as part of antiretroviral therapy.
Completed
Pharmacotherapy 2007 Jun;27(6):793-800Study 23c
Substudy to evaluate rifabutin and efavirenz pharmacokinetics in TB patients with HIV receiving efavirenz as part of antiretroviral therapy.
Completed
Clinical Infectious Disease 2005; 41:1343–9Serum Bank Study
Collection of documented serum specimens from patients with suspected or proven TB, from baseline through the course of therapy.
Completed
MultipleStudy 22
Randomized open-label trial to evaluate the efficacy of once-weekly isoniazid and rifapentine in the continuation phase of therapy for pulmonary TB.
Completed
Lancet 1999; 353:1843-47
Lancet 2002; 360:528-34
AJRCCM 2004;170:1360-6
Clin Infect Dis 2005;40:386-91
Am J Respir Crit Care Med 2006;174:344–348
Int J Tuberc Lung Disease 2006;10(5):542–549
Contemp Clinical Trials 2007;28:288-94
Int J Tuberc Lung Disease 2008 Sep;12(9):1059-64
ACTG Rad 2010 Feb;17(2):157-62. Epub 2009 Nov 11Study 22PK
Substudy to evaluate isoniazid, rifampin, and rifapentine pharmacokinetics in patients enrolled in Study 22.
Completed
Am J Respir Critical Care Med 2003; 167:1341-7Additional publications shown in listing of Publications & Presentations elsewhere on this webpage.
							
					
						Page last reviewed:  April 1, 2016					Content source: 	Division of Tuberculosis Elimination, National Center for HIV, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention homeTuberculosisBasic TB Factsplus iconHow TB SpreadsLatent TB Infection and TB DiseaseSigns & SymptomsTB Risk FactorsExposure to TBTB PreventionVaccinesTB & HIV CoinfectionTB and DiabetesTB TermsPersonal StoriesTesting & Diagnosisplus iconWho Should be TestedTesting for TB InfectionTesting in BCG-Vaccinated PersonsTB Screening and Testing of Health Care PersonnelTesting During PregnancyDiagnosing latent TB infection and TB diseaseTreatmentplus iconDeciding When to Treat Latent TB InfectionTreatment Regimens for Latent TB Infection (LTBI)Treatment for TB DiseaseAdverse EventsTB Treatment of Persons Living with HIVTB Treatment and PregnancyTB Treatment for ChildrenFrequently Asked QuestionsDrug-Resistant TBResearchplus iconTB Epidemiologic Studies Consortiumplus iconResearch ProjectsPublicationsTB Trials Consortiumplus iconStudy DescriptionsBackgroundBehavioral & Social Science ResearchHealth Care Settingsplus iconTB Infection Control in Health Care SettingsResources for TB Screening and Testing of Health Care Personnelplus iconFrequently Asked QuestionsTB in Specific Populationsplus iconHealth DisparitiesAsian PersonsBlack or African American PersonsHispanic or Latino PersonsChildrenPregnancyCorrectional FacilitiesPeople Experiencing HomelessnessInternational TravelersLaboratory Informationplus iconDrug Susceptibility TestingFalse-Positive Investigation ToolkitInterim Laboratory Biosafety Guidance for XDR  tuberculosis strainsModel Performance Evaluation Program (MPEP)Rapid Molecular Testing to Detect Drug-Resistant TB in the USplus iconExecutive SummaryIntroductionBackground on Tests for Molecular Detection of DRGeneral Considerations and Principles for a Molecular DR Testing ServicePossible Scenarios and Scope of Testing for a Molecular DR Testing ServiceResearch NeedsGeneral Recommendations of the Expert PanelCommunication Plan for the ReportRecommendationsReferencesPanel Members and CDC ParticipantsAppendix 1Appendix 2Appendix 3The Uses of Nucleic Acid Amplification Tests for the Diagnosis of TBplus iconGeneral ConsiderationsGeneral Recommendations of the Expert PanelRecommendations to ACET, CDC, DTBEData & Statisticsplus iconTB Incidence in the United StatesReported TB in the US, 2022 Surveillance Reportplus iconNational DataReporting Area DataRisk FactorsDemographicsTB Treatment and Case OutcomesDrug-Resistant TBMolecular SurveillanceTuberculosis in the United States, 2022 (Slide Set)Archived Surveillance Reports and Slide Sets2021 State and City ReportArchived State and City ReportsProfessional Resources & Toolsplus iconTools for Healthcare ProvidersResources for TB Programsplus iconStrengthening Civil Surgeons’ Capacity to Improve LTBI Surveillance and Outcomes Among Status AdjustersNotice of Funding Opportunity (NOFO)Program EvaluationTB Centers of ExcellenceTB Elimination AllianceTB Genotypingplus iconConventional TB GenotypingWhole Genome SequencingTB GIMSAnalytic ToolsLatent Tuberculosis Infection ResourcesPublications & Productsplus iconPatient and Public MaterialsFact SheetsGuidelinesplus iconControl & EliminationDrug-Resistant TBInfection Control & PreventionLaboratory & GenotypingTB & HIVTB in Specific PopulationsTesting & DiagnosisTreatmentVaccines & ImmunizationsArchived TB GuidelinesGuides & Toolkitsplus iconAggregate ReportsCDC TB Surveillance TrainingCore CurriculumEffective TB Interviewing for Contact InvestigationEthnographic GuidesFalse-Positive Investigation ToolkitForging Partnerships to Eliminate TuberculosisGuide to Application of GenotypingLTBI: A Guide for Primary Health Care ProvidersMantoux Tuberculin Skin Testing ProductsReport of Verified Case of Tuberculosis (RVCT)Self-Study ModulesTB Contact Investigation Interviewing Skills CourseTB eDOT ToolkitUnderstanding the TB Cohort Review ProcessNewslettersplus iconTB Notes, No. 4, 2023TB Notes, No. 3, 2023TB Notes. No. 2, 2023TB Notes. No. 1, 2023TB Notes, No. 4, 2022TB Notes, No. 3, 2022TB Notes, No. 2, 2022TB Notes, No. 1, 2022TB Notes, No. 4, 2021TB Notes, No. 3, 2021TB Notes, No. 2, 2021TB Notes, No. 1, 2021Pamphlets, Brochures, Bookletsplus iconQuestions and AnswersPatient Education SeriesTuberculosis - Get the FactsTuberculosis - The Connection between TB and HIV12-Dose Regimen for Latent TB Infection-Patient Education BrochurePostersplus iconMantoux Tuberculin Skin Test Wall ChartWorld TB DayThink TBStop TBTake on TBReports & Articlesplus iconDTBE Authored Journal ArticlesTuberculosis Laboratory Aggregate ReportsSlide Setsplus iconIntroduction to TuberculosisEpidemiology of Tuberculosis Among Non-U.S.​–Born Persons in the United States, 1993–2016Self-Study Modules on Tuberculosis, 1-5 Slide SetsThe Tuberculosis (TB) in Correctional Settingsplus iconFacilitator GuideIntroduction to TB GenotypingEpidemiology of Tuberculosis in Correctional Facilities, United States, 1993-2017Prevention and Control of Tuberculosis in Correctional and Detention FacilitiesGuidelines for Preventing the Transmission of M. TB in Health care SettingsInvestigation of Contacts of Persons with Infectious TBEpidemiology of Pediatric Tuberculosis in the United StatesTargeted Tuberculosis Testing and Treatment of Latent Tuberculosis InfectionElectronic Tools & ResourcesWeb-Based Courses & Webinarsplus iconTB 101 for Health Care WorkersContent SyndicationInfographicsplus iconSocial Media GraphicsCustomizable Take on TB Infographic with InstructionsEventsWorld TB Dayplus iconU.S. TB ChampionsHistoryFeaturesplus iconTB Risk FactorsTreating Latent TB Infection with Short-Course RegimensWorld Tuberculosis (TB) Day 2021World Tuberculosis (TB) Day 2020Linksplus iconState TB Control OfficesAbout Usplus iconMission Statement and Activitiesplus iconDTBE Strategic PlanNational TB Program ObjectivesOrganization ChartAdvisory Groupsplus iconFederal TB Task Force To receive email updates about this page, enter your email address: Email Address			What's this?				Submit


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