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Tuberculosis Trials ConsortiumProjectsCompleted and ongoing TBTC Studies 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. Study 22 PK Substudy: Substudy to evaluate isoniazid,
rifampin, and rifapentine pharmacokinetics in 150-200 patients enrolled
in Study 22. Completed. Study 22 Retention Substudy: Substudy to evaluate factors affecting retention of patients enrolled in Study 22. 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.
Aims to enroll 200 patients over 2 years, with 2-year follow-up.
Completed. Study 23a: Substudy to evaluate isoniazid and
rifabutin pharmacokinetics in Study 23 TB patients with HIV receiving
antiretroviral therapy. Completed. 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 Substudy: Study of the performance of several nucleic acid amplification 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. Study 25PK: Substudy to examine pharmacokinetics
of rifapentine at each of 3 doses in patients who are participants
in Study 25. Completed. Study 26: Randomised, open-label Phase III clinical trial of 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 therapy with isoniazid. Aims to enroll 7,700 persons. Enrolling. Study 26A: Substudy of risk factors for hepatotoxicity in Study 26. Enrolling. Study 26HS: Substudy to examine the association between hypersensitivity syndrome and the presence of serum antibodies to isoniazid and/or rifapentine. Enrolling. 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. 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. Enrollment completed. 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. Enrolling. Study 29: In design phase. Last Modified: 04/27/2007 Last Reviewed: 05/18/2008 |
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Centers for Disease Control & Prevention |