CDC History of Tuberculosis Control - Medical and Public Health ...

multicenter clinical trials that helped to establish
rifampin-based, short-course therapy as
the standard for TB treatment. It also conducted
studies to provide the scientific basis
for preventive chemotherapy, which remains a
major component of our TB elimination
strategy.
Support for the infrastructure required for
these studies gradually diminished, so that the
last completed trial, USPHS Study 21, was
nearly terminated several times during its
course for lack of adequate funding. With the
infusion of federal support for TB control and
elimination in the early 1990s, CDC established
a consortium of clinical investigators for
the specific purpose of conducting USPHS
Study 22, a trial of once-weekly isoniazid and
rifapentine in the continuation phase of
therapy for pulmonary TB. This consortium,
whose sites include public health departments,
academic medical centers, and VA medical
centers (VAMC), required both time and
substantial financial resources to establish and
support, but is now functioning efficiently.
Did you know that...
Aspirin was developed as a cure for
tuberculosis? Researchers in Switzerland
looking for a cure for TB were excited to
discover that one particular compound
was able to relieve the fever and pain of
TB patients. They subsequently found that
it only provided temporary relief, not a
cure, and they put the drug aside. The
compound was later rediscovered and named
aspirin (from A. Karlen, Man and Microbes,
Putnam & Sons, NY, 1995).
Currently new drugs and regimens for both
TB treatment and prevention, new diagnostic
tests, and new vaccine candidates are becoming
available for clinical investigation. Concurrently,
the challenges posed by the goal of TB
elimination are increasing, as global rates of
drug resistance increase and as the costs associated
with assuring high rates of adherence rise.
Notable Events in TB Control
53
The consortium now provides a unique and
important resource for further clinical studies,
and has demonstrated its ability to play an
important role in TB treatment and
prevention.
The original group of clinical sites included 12
academic centers and health departments (7
contracts issued in 1993, and 5 more in 1994),
and 15 VAMCs (funded through a Memorandum
of Agreement with the Washington, DC,
VAMC). Enrollment into USPHS Study 22
began in April 1995, and continued to completion
in November 1998. In 1997 CDC began
working with the USPHS Study 22 investigators
to develop a structure that would engage
more fully the capacities of the study investigators
in the work of the group. The TBTC was
thus organized, with formal by-laws adopted
in 1998. Several working committees were
established; these are composed of selected
Consortium investigators and coordinators, in
collaboration with CDC staff. One committee
(Core Science) oversees the scientific program
of research, a second (Implementation and
Quality) supervises the conduct and quality of
ongoing studies, and a third (Executive Affairs)
serves as the executive arm of the steering
committee. This structure is modeled on
the Community Programs for Clinical Research
on AIDS (CPCRA), which is supported
by the National Institute of Allergy and
Infectious Diseases (NIAID).
In 1999 the TBTC underwent a formal external
re-competition. New 10-year contracts
were awarded to 13 offerors (7 prior TBTC
members and 6 new sites). The VA side of the
consortium underwent a similar process, and
funded 10 VA Medical Centers to continue as
members of the TBTC.
The current studies of the TBTC are as follows:
Study 22: Randomized open-label trial to
evaluate the efficacy of once-weekly isoniazid
and rifapentine in the continuation phase of