Tuberculosis Trials Consortium (TBTC)
Completed and Ongoing TBTC Studies
| Study | Title | Status | References |
|---|---|---|---|
| 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 | |
| Study 35 | Evaluation of RFPT PK in HIV-uninfected children 0-12 years of age | To begin Late 2016 | |
| 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 | |
| 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 |
Completed | |
| 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” | Began 2015; enrolling | |
| Study 31 | Rifapentine-containing treatment shortening regimens for pulmonary tuberculosis: A randomized, open-label, controlled phase 3 clinical trial. | To begin early 2015 | |
| 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 | |
| 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 | Published, AJRCCM 2015 |
| Study 29A | Phase 1 dose escalation of rifapentine in healthy volunteers (at Johns Hopkins) | Completed | Published AAC, 2015 |
| Study 29PK | Substudy to characterize rifapentine pharmacokinetic (PK) parameters in patients with TB. | Completed | Published AAC, 2015 |
| 29X 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. |
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 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 | 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; 174:331–338 |
| 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 | |
| Study 26HS | Substudy to examine the association between hypersensitivity syndrome and the presence of serum antibodies to isoniazid and/or rifapentine. | Enrollment Completed | |
| 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 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: 1526-1530 |
| 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 |
| 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 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 |
| 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 |
| 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 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 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 |
Additional publications shown in listing of Publications & Presentations elsewhere on this webpage.
Page last reviewed: April 1, 2016