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No. 2, 2014

CLINICAL RESEARCH BRANCH UPDATES

Summary of March TBTC Meeting

The Tuberculosis Trials Consortium (TBTC), a CDC-sponsored collaboration in TB clinical trials, is composed of clinical investigators from academic medical centers, health departments, and U.S. Department of Veterans Affairs medical centers located in the United States, Hong Kong, Kenya, Peru, South Africa (2 centers), Spain, Uganda, and Vietnam. The TBTC mission is to conduct programmatically relevant research concerning the diagnosis, clinical management, and prevention of tuberculosis infection and disease. These centers work in collaboration with Division of Tuberculosis Elimination (DTBE) staff to perform Phase II and Phase III clinical trials and pharmacokinetic studies in TB treatment and prevention. The consortium normally meets 1–2 times a year to provide study updates to Consortium members, to perform needed training for ongoing or upcoming studies, to review new developments in TB therapeutics and in clinical trials, and to allow a large number of TBTC work groups to meet in person.

During March 17–19, 2014, TBTC members gathered in Decatur, Georgia, for the 34th semi-annual meeting. Over 125 participants representing clinical research sites, academia, pharma, WHO, other TB clinical trials groups, and other federal agencies attended this year’s meeting.

On March 17, the consortium’s Community Research Advisory Group (CRAG) met to review directions for TB therapeutic research, provide an update on these community representatives, and develop their work plan. That same day, there were 6 hours of protocol training for coordinators involved in the new Study 36 Platform study. The group’s Executive Affairs Group also met.

On March 18, the TBTC met in plenary to review progress on Study 26 and the 3HP sub-studies, including updates on the hypersensitivity and post-marketing studies. Drs. Andrey Borisov and Bob Belknap summarized the status of Study 33/iAdhere, which is evaluating self-administration of the 3HP regimen for LTBI. Diagnostic activities were reviewed as part of the Study 34 and Study 29X Gene Xpert updates. Dr. Anneke Hessling presented on treatment markers in children. That afternoon, eight work groups, committees, and protocol teams convened for working meetings (Adverse events, Pharmacokinetics, LTBI, Phase 2, Microbiology and Diagnostics, Study 33, and Core Science, Advocacy and External Relations), in addition to a meeting of site coordinators.

The March 19 plenary focused on active TB disease. Dr. Susan Dorman summarized outcomes for Hopkins’s studies of moxifloxacin and rifapentine in Rio and Cape Town. Prof. Andrew Nunn from the UK Medical Research Council offered a perspective on phase 3 TB clinical trials. Dr. Christian Lienhardt provided an update on WHO’s effort to assure rational introduction of new drugs. Dr. Dan Everitt shared the phase 3 perspective of the TB Alliance. A series of presentations reviewed activities involving rifapentine: Dr. Marilyn Maroni from Sanofi presented findings from their rifapentine-efavirenz interaction study, Dr. Marc Weiner shared recent findings from TBTC work on pharmacokinetic and pharmacodynamic studies of rifapentine, and Dr. Payam Nahid presented and led a discussion on the planned phase 3 study of high-dose rifapentine-based 4-month therapy for TB disease (TBTC Study 31). Drs. Mike Vjecha and Debra Benator discussed the platform diagnostic study and projects (Study 36 and 36A), and Drs. Jason Stout and Kelly Dooley summarized the state of the group’s phase 2 plans. That afternoon, six work groups, teams, and committees convened (Biomarkers, Study 31 team, MDR, Study 35 [pediatric pharmacokinetics of rifapentine], Core Science, and EAG).

The following day, the protocol team for Study 32 had a day-long meeting and training session. Study 32 (Opti-Q) involves optimization of dosing of levofloxacin in MDR treatment.

The TBTC meetings are open and public meetings. For more details, please contact Andy Vernon, Beverly DeVoe Payton, Stefan Goldberg, Bill Mac Kenzie, or Lorna Bozeman in DTBE’s Clinical Research Branch.

Submitted by Beverly DeVoe Payton
Div of TB Elimination

 
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