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U.S. Department of Health and Human Services

  

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TB Notes 3, 2004

UPDATE FROM THE CLINICAL AND HEALTH SYSTEMS RESEARCH BRANCH

TB Trials Consortium Update

The Tuberculosis Trials Consortium (TBTC) had its 15th Semi-Annual Meeting May 21 and 22 in Orlando, Florida. The principal investigators, study coordinators, site monitors, and data and coordinating center staff of the TBTC have been meeting regularly since 1995, when the original research group started its first clinical trial in the newest series of USPHS clinical trials to study drugs for tuberculosis treatment. The mission of the TBTC is “… to conduct  programmatically relevant clinical, laboratory, and epidemiologic research concerning the diagnosis, clinical management, and prevention of tuberculosis infection and disease,” and as such the TBTC staff use these face-to-face meetings to review the newest ongoing or planned science projects for the TBTC. The TBTC’s research agenda is guided by a comprehensive review of the important unanswered questions in TB therapeutics and a determination of what studies are being done or are planned by other research groups, accomplished by prioritizing the important questions with input from TBTC members, DTBE staff, and staff of the Advisory Council for the Elimination of Tuberculosis (ACET).

In addition to attendees from the TBTC Study Sites and the CDC-TBTC staff, the 15th Semi-Annual Meeting welcomed in attendance DTBE’s Director, Dr. Ken Castro; DTBE’s Associate Director for Science, Dr. Michael Iademarco; and the new Clinical and Health Systems Research Branch (CHSRB) Chief, Dr. Andy Vernon. Outside guests and speakers included Dr. Surjeel Choudhri (Bayer Pharmaceuticals); Dr. Mel Spiegelman (Global Alliance for TB Drug Development, GATB); Dr. Jeffrey Starke (Baylor University), addressing the issue of Research Priorities for Childhood Tuberculosis; Dr. Kevin DeCock (CDC-GAP Director, Kenya Field Station), addressing the issue of Research Priorities for TB-HIV in Africa; Dr. Barbara Laughon (Chief, Complications and Co-Infections Research Branch, Therapeutics Research Program, Division of AIDS, NIAID, NIH); and Dr. Jose M. Miro (Hospital Clinic University, Spain), addressing the issue of Research Priorities for TB-HIV in Western Europe. Of note, Dr. Miro is also co-principal investigator of the TBTC site in Barcelona, Spain.

A few highlights from the 15th Semi-Annual Group Meeting:

  • The Data Safety and Monitoring Board of the TBTC reviewed all TBTC clinical trials open for enrollment on May 5, 2004, and approved their continuation for one year.
  • Study 26, “A Study of the Effectiveness and Tolerability of Weekly Rifapentine and Isoniazid for Three Months Versus Daily Isoniazid for Nine Months for the Treatment of Latent Tuberculosis Infection,” will migrate this summer from its current system of patient enrollment (by phone, with study site staff calling in to the CDC data center) to a study site web-based enrollment system.
  • All TBTC sites participated in or supported the “Race to Enroll 3,000 Study 26 Patients.” This fun event started January 23, 2004, when the group was challenged to enroll 518 new patients into Study 26 by May 21, 2004 (only 120 days!) and bring the total count of patients enrolled in this study to 3,000. The race participants received enrollment updates and encouragement every 2 weeks by e-mail (sent courtesy of Minnie Mouse) and to the group’s pleasure (and some disbelief!), the enrollment count reached 3,005 (see graph). All the TBTC sites contributed enthusiastically with patient enrollments, but it was the site at the University of North Texas Health Science Center (UNTHSC), under the direction of Dr. Stephen Weis, that had the distinction of both “the most patients enrolled during the race period” and “site enrolling patient number 3,000.”  Congratulations are in order for the whole group, as this was truly a TBTC-wide effort.
  • The enrollment pace is ahead of schedule for Study 27, “A double-blind, placebo-controlled comparison of the efficacy and tolerability of moxifloxacin with ethambutol when each is used with isoniazid, rifampin, and pyrazinamide during the initiation phase of treatment of pulmonary TB;” the total number needed is 300 patients and 221 have already been enrolled. The TBTC site in Kampala, Uganda, under the direction of Dr. John Johnson (Case Western Reserve University [CWRU]) and Dr. Grace Muzanye (Uganda-CWRU Research Collaboration) has enrolled about 50% of the total patients in Study 27 to date.
  • Drs. Bill Burman and Peter Breese (TBTC site at the Denver Public Health Department), Steve Weis (TBTC-UNTHSC), and Stefan Goldberg (TBTC-CDC) were the first recipients of the NCHSTP/CDC funding for research in ethics and human subjects protection for their proposal “Study of the Effect of Primary Language on the Comprehension of the Informed Consent for a TB Clinical Trial.”
  • Dr. Carol Dukes Hamilton, TBTC researcher from Duke University Medical Center, responded to an RFP from the NIH with a proposal for “Enhancing the USPH System’s Capacity to Engage in Clinical Research.”

TBTC budget news:

  • To help address DTBE’s funding deficit, the TBTC is implementing a $480,727 budget reduction in 2004. The budget for the remaining TBTC contract period (2005-2008) is being analyzed for further reductions. Recommended reductions will be based on performance, future needs, cost/patient, and other factors. The CDC/DTBE budget for TBTC activities projected to be available is <$9.2 million per year for 2005-2008. Funds for TBTC activities obtained from sources outside DTBE will complement and not supplement DTBE’s funds for TBTC.

TBTC personnel news:

  • Dr. Earl Hershfield, principal investigator from the TBTC site at the University of Manitoba, Canada, celebrated a young 70th birthday.
  • Bill Stanton, RN, Study Coordinator from the TBTC site at the University of California in San Francisco (UCSF), announced his retirement from the TBTC and from public health as of June 2004.
  • Dr. Chuck Daley, also from the TBTC-UCSF, announced his departure as principal investigator for this site and his new position as chief of Respiratory Infections and Mycobacterial Disease at the National Jewish Medical and Research Center Department of Medicine.
  • Dr. Robert Jasmer will assume the role of principal investigator at UCSF.

The TBTC will meet again October 20 and 21 in Atlanta, Georgia. Until then, please see our two most recent publications:

  • Weiner M, Bock N, Peloquin CA, Burman WA, Khan A, Vernon A, Zhao Z, Weis S, Sterling TR, Hayden K, Goldberg S, and the Tuberculosis Trials Consortium. Pharmacokinetics of rifapentine at 600, 900, and 1,200 mg during once-weekly tuberculosis therapy. Am J Respir Crit Care Med 2004; 169:1191–1197.
  • Gordin FM. Rifapentine for the treatment of tuberculosis: is it all it can be? Editorial. Am J Respir Crit Care Med 2004; 169:1176-1177.

Number of Patients Enrolled (n=3,005) in Study 26 by May 21, 2004.
FY 2001*-2004.**  Total Number Needed = 8,000.

Chart showing number of patients enrolled (3,005) in Study 26 by May 21, 2004, by individual site and color-coded by year of enrollment
* Study 26 started June 2001 and thus FY 01 and 02 are combined.
**FY 04 up to 05/21/04. Sites 15, 16, 29, and 40 started Study 26 in FY 03, Site 31 in FY 04.

—Reported by Elsa Villarino, MD, MPH
Div of TB Elimination

 


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