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Tuberculosis Trials Consortium (TBTC)

Completed and Ongoing TBTC Studies

Study Title Status References
Study 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

Lancet1999; 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 11
Study 22PK Substudy to evaluate isoniazid, rifampin, and rifapentine pharmacokinetics in patients enrolled in Study 22. Completed Am J Respir Critical Care Med 2003; 167:1341-7
Serum Bank Study Collection of documented serum specimens from patients with suspected or proven TB, from baseline through the course of therapy. Completed Multiple
Study 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; 51:214-5
Study 23a Substudy to evaluate isoniazid and rifabutin pharmacokinetics in Study 23 TB patients with HIV receiving antiretroviral therapy. Completed

Clinical Infectious Disease 2005;40:1481-91

Study 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):793-800
Study 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; 41:1343–9
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)571-581
NAA 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 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

Am J Resp Crit Care Med 2002; 165: 1526-1530

Study 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;169:1191-7

Study 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;60:1650-1653

Study 26A Sub-study of risk factors for hepatotoxicity in Study 26.

Completed

Submitted
Study 26HS Substudy to examine the association between hypersensitivity syndrome and the presence of serum antibodies to isoniazid and/or rifapentine.

Enrollment Completed

In process
Study 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, 2014

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; 174:331–338
Study 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:e18358
Study 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 Antimicrobial Agents and Chemotherapy (AAC), 2010
Study 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;206:1030-1040

Study 29X Enrollment complete in the main study. Study amended with extension to evaluate safety of higher rifapentine doses. Completed Submitted
Study 29 A Phase 1 dose escalation of rifapentine in healthy volunteers (at Johns Hopkins) Completed AAC, In press 2014
Study 29PK Substudy to characterize rifapentine pharmacokinetic (PK) parameters in patients with TB. Completed AAC, In press 2014
29XSparse 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.
Completed  
Study 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)
Completed  
Study 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;16:1582-7

Study 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). Completed Pending
Study 31 Rifapentine-containing treatment shortening regimens for pulmonary tuberculosis: A randomized, open-label, controlled phase 3 clinical trial. To begin late 2014
Study 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” To begin Mid 2014
Study 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 Enrollment Completed  
Study 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 Completed In analysis
Study 35 Approach to evaluation of RFPT PK in HIV-uninfected children 0-12 years of age To begin Mid 2014
Study 36 Platform for Assessment of TB Treatment Outcomes An Observational Study of Individuals Treated for Pulmonary Tuberculosis (TB) Enrolling
Study 36A Biobank Substudy: An Observational Study of Individuals Treated for Pulmonary Tuberculosis (TB) Enrolling


Additional publications shown in listing of Publications & Presentations elsewhere on this webpage.

 
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