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TB Notes 4, 2004
No. 4, 2004
UPDATE FROM THE CLINICAL AND HEALTH SYSTEMS RESEARCH
Updates on the TB Trials Consortium (TBTC)
Enrollment Update: U.S. PHS TBTC Study 27
Enrollment for U.S. Public Health Service (PHS) TBTC Study 27,
a double-blind, placebo-controlled comparison of the efficacy and
tolerability of moxifloxacin versus ethambutol in the initiation
phase of treatment of pulmonary TB, began in July 2003 at North
America TBTC sites and in September 2003 at the Kampala, Uganda,
site. Initially proposed to study 300 patients and to take 3 years
to complete, the pace of enrollments is exceeding expectations.
Of the 290 patients thus far enrolled, there has been an equal distribution
of enrollments contributed from North America and from the Uganda
TBTC sites. The pace of enrollments is expected to accelerate further
with the participation of the Durban, South Africa, TBTC site in
Study 27, which enrolled its first three patients on July 22, 2004.
Because of these developments, it is hoped that enrollment for the
entire study will be completed by early- to mid-January 2005 and
that preliminary analyses can be completed in time for the May 2005
TBTC and American Thoracic Society (ATS) conferences.
TBTC Study 27 PK
A new substudy of Study 27, “Study 27 PK,” was recently approved
by the CDC institutional review board (IRB), and will be carried
out at a limited number of TBTC sites. Consisting of two parts,
this pharmacokinetic study will (a) compare the concentrations of
moxifloxacin among patients receiving multidrug therapy for active
TB to those of healthy volunteers; and (b) characterize the inter-patient
variation of moxifloxacin pharmacokinetic parameters in patients
with TB. Study 27 PK will also evaluate the effect of MDR1 and NAT2
genes on antituberculosis drug pharmacokinetics.
TBTC Study 28
Another new moxifloxacin study on the TBTC horizon is Study 28,
which is currently undergoing review by the CDC IRB. The main comparison
in Study 28 involves moxifloxacin with isoniazid (rather than ethambutol).
Specifically, the primary objective of this Phase II clinical trial
is to compare the safety and activity of a moxifloxacin-containing
regimen (moxifloxacin, rifampin, pyrazinamide, ethambutol) in which
moxifloxacin has been substituted for isoniazid, to the standard
control regimen (isoniazid, rifampin, pyrazinamide, ethambutol)
in the first 2 months of treatment of sputum smear-positive pulmonary
TB. The assessment of microbiological activity will be sputum culture
conversion. Improved sputum culture conversion after 2 months of
treatment with a moxifloxacin-containing regimen would support phase
3 clinical trials of moxifloxacin in treatment regimens of less
than the current 6-month standard regimens. The plan is to enroll
400 patients from both domestic and international TBTC sites.
TBTC Study 26 Update: New Web-Based Enrollment Application
TBTC 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 and rifapentine, compared to standard 9-month
therapy with isoniazid. This flagship TBTC study aims to enroll
7,700 subjects. To date, enrollments have been telephone-based.
Recent consortium expansion to international sites, with the associated
multiple time zones, makes Web-based enrollment an attractive alternative.
TBTC Study 26 plans to roll out a new Web enrollment application
this fall. The Web application was developed as a pilot project
through collaboration between DTBE/CHSRB and the Application Development
Group, Prevention Informatics Office/NCHSTP. It will be accessible
from any Internet connection and requires a user name and password.
Advantages are immediate access for enrollments, increased clinic
participation, system availability 24/7, and generation of automatic
e-mail notification to sites regarding subject randomization and
TBTC Study 26 has already enrolled 3,275 subjects using a Visual
Basic/Access application developed in DTBE/CHSRB. Site staff members
who call CDC to enroll study subjects occasionally experience delays
owing to time zone constraints or when CDC staff are taking other
calls. The Web enrollment application will allow real time access
for TBTC Study 26 collaborators throughout the United States and
in Canada, Brazil, and Spain. Our hope is to increase the pace of
enrollments, moving us quickly to our recruitment goal for Study
—Submitted by Phil Spradling, MD
Div of TB Elimination
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