TB Notes Newsletter
No. 1, 2006
TB TRIALS CONSORTIUM UPDATE
TBTC Study Enrollment
Study 24 is a single-arm study of largely intermittent, short-course
therapy for patients with INH-resistant TB or INH intolerance. Enrollment
closed December 2004 with a total of 98 patients. By mid 2007, all
patients will have reached the end of follow-up for study outcomes
(e.g., treatment failure and relapse).
Study 26 is a trial of short-course treatment of latent TB infection
among contacts of active cases, using a 3-month, once-weekly regimen
of isoniazid 900 mg and rifapentine 900 mg, compared to standard
9-month daily therapy with isoniazid 300 mg. As of January 19, 2006,
Study 26 enrollment was up to 5,485, over 68% of the intended subjects
for total enrollment. These 5,485 subjects include 294 persons under
18 years of age.
Study 27 is a double-blind, placebo-controlled evaluation of 2-month
culture conversion rates when substituting moxifloxacin for ethambutol
in the 2-month intensive phase of treatment of pulmonary TB. A total
of 336 patients were enrolled between July 2003 and March 2005.
Over 50% of patients were enrolled from two African study sites.
The first preliminary results were presented in May 2005. There
was no difference between the moxifloxacin and the ethambutol study
arms in 2-month culture conversion; these rates were both 71%. There
were differences, however, between North American sites and African
sites, with significantly more North American patients converting
their sputum to negative by 2 months (85%) compared to African patients
(63%). Further analyses are ongoing.
Study 28 is a double-blind, placebo-controlled study of 2-month
culture conversion rates when substituting moxifloxacin for isoniazid
in the 2-month intensive phase of treatment of pulmonary TB. This
isoniazid-sparing regimen for TB treatment is based on data from
the murine model of tuberculosis. In the murine model, the substitution
of moxifloxacin for isoniazid resulted in significant reduction
in the time to sterilization when compared to the standard combination
of rifampin, isoniazid, and pyrazinamide. Improved sputum culture
conversion after 2 months of treatment with a moxifloxacin-containing
regimen would support movement to phase-3 clinical trials of moxifloxacin-based
treatment regimens of less than the current 6-month standard duration.
Study 28 will enroll 410 patients from both domestic and international
TBTC sites. Enrollment is expected to begin in early 2006.
—Reported by Susan Ray, MD
Emory University School of Medicine
Member, Advocacy & External Relations Committee
TB Trials Consortium
Released October 2008
Centers for Disease Control and Prevention
National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention
Division of Tuberculosis Elimination - http://www.cdc.gov/tb
Please send comments/suggestions/requests
CDC/Division of Tuberculosis Elimination
Communications, Education, and Behavioral Studies Branch
1600 Clifton Rd., NE - Mailstop E-10, Atlanta, GA 30333