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Tuberculosis Trials Consortium (TBTC)

Selected 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 Lancet, 1998, Lancet, 2002
Study 22PK Substudy to evaluate isoniazid, rifampin, and rifapentine pharmacokinetics in patients enrolled in Study 22. Completed American Journal of Respiratory and Critical Care Medicine
Study 22 Substudy to evaluate factors affecting retention of patients enrolled in Study 22. Completed  
Serum Bank Study Collection of documented serum specimens from patients with suspected or proven TB, from baseline through the course of therapy. Completed  
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 American Journal of Respiratory and Critical Care Medicine, 2006
Study 23a Substudy to evaluate isoniazid and rifabutin pharmacokinetics in Study 23 TB patients with HIV receiving antiretroviral therapy. Completed Clinical Infectious Diseases, 2004
Study 23b Substudy to evaluate rifabutin and nelfinavir pharmacokinetics in TB patients with HIV receiving nelfinavir as part of antiretroviral therapy.

Completed

  
Study 23c Substudy to evaluate rifabutin and efavirenz pharmacokinetics in TB patients with HIV receiving efavirenz as part of antiretroviral therapy. Completed  
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. In follow-up  
NAA Study of the performance of several nucleic acid amplification (NAA) methodologies in the diagnosis and management of active TB Enrolling  
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 American Journal of Respiratory and Critical Care Medicine, 2000
Study 25PK Substudy to examine pharmacokinetics of rifapentine at each of 3 doses in patients who are participants in Study 25. Completed American Journal of Respiratory and Critical Care Medicine, 2001
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 for main data analysis population (8,053 patients) as per protocol.

Follow-up continues for the additional second cohort populations (young children and HIV positive) only.

Prevent TB Study (Fact Sheet)

Research offers simpler, effective treatment option for latent TB infection (Press Release)
Study 26A Sub-study of risk factors for hepatotoxicity in Study 26.

Enrollment 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  
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 American Journal of Respiratory and Critical Care Medicine, 2006
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 American Journal of Respiratory and Critical Care Medicine, 2009
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  
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. Enrolling  
Study 29PK Substudy to characterize rifapentine pharmacokinetic (PK) parameters in patients with TB. Enrolling  
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.

Enrolment Completed

  
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).    
 
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