Tuberculosis Trials Consortium
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Projects
Completed and ongoing TBTC Studies
(Updated April 2007)
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 22 PK Substudy: Substudy to evaluate isoniazid,
rifampin, and rifapentine pharmacokinetics in 150-200 patients enrolled
in Study 22. Completed.
(American Journal of Respiratory and Critical Care Medicine)
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.
(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 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.
(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: 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 Content Source: Division of Tuberculosis Elimination
National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention
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