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No. 2, 2009

CLINICAL AND HEALTH SYSTEMS RESEARCH BRANCH UPDATE


A Brief History of the TBTC

The Tuberculosis Trials Consortium (TBTC) is a consortium of U.S. and international TB investigators funded by CDC. It is a unique public-private sector partnership between researchers from CDC, local public health agencies, leading academic centers, and selected Veterans Administration (VA) medical centers.  Current TBTC studies extend the historic role of the U.S. Public Health Service (USPHS) in TB research. We offer the following brief history of the TBTC as a reminder of the uniqueness and historical significance of this group.

Before streptomycin became available in 1946, humans lived in terror of TB because of the illness, disfiguration, and death it caused. Before publication of the first streptomycin study, controlled clinical trials in humans had never been conducted, so there was no way to compare the effect and value of an intervention or treatment with a control. There is little doubt that the discovery of a cure for TB changed human history, and that the development of controlled clinical trials has greatly benefited science and mankind.

The development of TB drug therapy was a landmark in the fight against TB. Groups such as the British Medical Research Council and the U.S. Public Health Service have studied TB medications since the discovery of streptomycin in 1944. In the early 1960s, TB treatment was recommended to last 24 months, and to require 1,460 doses of medication and hospitalization (Tubercle 1962, 43:201-67). Less than 20 years later in 1979, treatment had been shortened to 6 months, requiring 96 doses of medications and no hospitalization; and very importantly, it did not engender acquired drug resistance when taken as prescribed (Am Rev Respir Dis 1979;579-85).

CDC has had a major role in the clinical trials for TB since the PHS TB control program was transferred from the National Institutes of Health (NIH) to CDC in 1960. From then until 1988, CDC coordinated a series of multicenter clinical trials that helped to establish rifampin-based, short-course therapy as the recommended initial treatment of TB in the United States. It also conducted studies that provided the scientific basis for preventive therapy, which remains a major component of our strategy to eliminate TB.

However, with the gradual diminution of the infrastructure required for these studies, the last completed trial of that era (USPHS Study 21) was nearly terminated several times during its course for lack of adequate funding.  However, with the infusion of federal support for TB control in the early 1990s and with new candidate TB drugs available, CDC re-established its commitment to study new drugs and regimens for both TB treatment and prevention with the creation of the TBTC.

TBTC initiated its first TB treatment trial in 1995. Since then, TBTC has grown to include sites on four continents and has worked with its partners to conduct a variety of phase II and III clinical trials that have enrolled more than 10,000 patients and volunteers. In the coming few years, TBTC will complete the largest TB prevention trial ever conducted: TBTC Study 26, a Phase III trial testing the efficacy of a 3-month, once-weekly regimen of isoniazid and rifapentine, under supervised administration, for the treatment of LTBI.  In addition, TBTC recently completed two Phase II studies showing that moxifloxacin is safe and effective during intensive phase treatment; enrolled approximately one half of a Phase II study of daily rifapentine during intensive phase treatment; started enrollment in a study of linezolid for multidrug-resistant TB (MDR TB); and is conducting a number of studies of the pharmacokinetics, pharmacodynamics, biomarkers, drug interactions, basic microbiology, and human subjects protection issues that are crucial elements of international TB clinical trials research.

Despite the advances in TB treatment research such as the advent of new drugs, new diagnostic tests, and new vaccine candidates for TB, challenges remain:

  1. TB is still a leading infectious disease (with over 9 million new cases and almost 2 million deaths per year);
  2. The current standard regimen must still be taken for 6 to 9 months;
  3. The continued spread of MDR TB threatens the control of TB globally;
  4. Rifampin-based TB treatment is incompatible with many current antiretroviral therapy (ARV) regimens; and
  5. Costs for assuring high rates of treatment adherence are rising.

Though these challenges remain, we look forward with optimism; the new drug candidates and advances in current TB clinical trial science are among the most promising we have seen.  With commitment and support from DTBE, the TBTC is providing a unique resource for these clinical studies, and will continue to play an important role in improving TB treatment and prevention.

—Reported by Elsa Villarino, MD,
and Stefan Goldberg, MD
Div of TB Elimination

 

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