Dear Colleague Letters
Tuberculosis Trials Consortium Awards for the 2021-2030 Cycle
March 31, 2021
The U.S. Centers for Disease Control and Prevention is pleased to announce the members of its Tuberculosis Trials Consortium (TBTC) for the 2021-2030 cycle.
CDC’s domestic tuberculosis (TB) program conducts vital, unparalleled clinical trials and epidemiologic research through the TBTC, which advances the TB elimination strategy in the United States and globally. Earlier this fiscal year, CDC awarded contracts for the next ten-year research cycle, 2021 – 2030, initiating the 28th year of this collaborative effort.
Since it began in 1993, TBTC has been responsible for several major clinical trials that have significantly impacted TB treatment. The results of TBTC Studies 22 and 26 substantially influenced the most recent American Thoracic Society/CDC guidelines for treatment of both TB disease and latent TB infection. Most recently, the landmark TBTC Study 31/ACTG A5439 demonstrated that the efficacy of a four-month daily treatment regimen containing a combination of rifapentine and moxifloxacin is non-inferior to the standard six-month daily regimen at curing drug-susceptible TB disease. The results of this study will help inform future TB disease treatment guidelines and innovations for designing future clinical trials. Other TBTC study results have led to modification of CDC’s recommendations for treatment of TB and HIV.
TBTC sites are funded in one of two ways, through individual contracts with CDC or as part of a sub-network coordinated by the Washington DC Veterans Affairs Medical Center. Every 10 years both sides of the consortium undergo competition. This open competition ensures that the consortium’s activities remain vigorous and innovative, as well as ensure that the costs remain competitive. As in prior years, this exercise resulted in awards to new as well as previous clinical sites. The new and continuing members of TBTC combine outstanding scientific expertise and superb TB trials capacity. As in the past, some of these awards reflect collaborations involving North American and international institutions. This cycle of TBTC also consists of both prior and new vendors, as well as investigators from Veterans’ Affairs (VA) Medical Center sites, and CDC scientists. Below is a description of the contracted members of TBTC for the 2021-2030 cycle.
- CASE-KAMPALA: Case Western Reserve University and the Uganda-Case Western Reserve University Research Collaboration, in Kampala, Uganda (Site #30), PIs John L. Johnson, MD; Harriet Mayanja-Kizza; Moses L. Joloba
- CORNELL/HAITI: Joan & Sanford I. Weill Medical College of Cornell University (Site #45) under PI Daniel Fitzgerald, MD and GHESKIO Centers in Port-au-Prince, Haiti (Site #67) under Jean William Pape, MD
- DENVER: The Denver Metro Tuberculosis Clinic, part of Denver Public Health, in Denver, Colorado (Site #22), PI Robert Belknap, MD
- MCGILL/CAB-V: The CAB-V Network (an established group of investigators at 8 sites in the 5 largest cities in Canada, and the largest cities in Australia, Benin, and Vietnam), PI’s Dick Menzies (McGill University); James Johnston (University of British Columbia) and Greg Fox (University of Sydney), including the following:
- McGill University Health Centre tertiary hospital, Montreal, Canada (Site #25), PI Dick Menzies, MD
- Edmonton TB Clinic, Alberta, Canada (Site #99), PI Dick Menzies, MD
- Toronto Western Hospital, Toronto, Canada (Site #50), PI Dick Menzies, MD
- TB clinic Calgary TB Clinic Alberta, Canada (Site #51), PI Dick Menzies, MD
- Vancouver, British Columbia, Centre for Disease Control, Vancouver (Site #52) PI James Johnston, MD
- Royal Prince Alfred Hospital, Sydney, Australia (Site #71), PI Greg Fox, MD
- Parramatta Chest Clinic Parramatta, Australia (Site #72), PI Greg Fox, MD
- Liverpool Hospital, Liverpool, Australia (Site #73), PI Greg Fox, MD
- District 6 TB Unit, Ho Chi Minh City, Vietnam (Site #74), PI Greg Fox, MD
- Phoi Viet Respiratory Centre, Ho Chi Minh City, Vietnam (Site #75), PI Greg Fox, MD
- Thot Not District TB Unit, Can Tho Province (Site #76), PI Greg Fox, MD
- National Referral University Hospital for Pneumo-physiology in Cotonou, Benin (Site #77), PI Menonli Adjobimey, MD
- MUSC/UCTLI: The Medical University of South Carolina under PI Susan Dorman, MD, in collaboration with the University of Cape Town Lung Institute (UCTLI) in Cape Town, South Africa (Site #09), PI Dr. Rodney Dawson (Bio Analytical Research Corporation partnership)
- SEATTLE: The Seattle & King County – Public Health TB Control Program, in Seattle, Washington (Site #26), PIs Masa Narita, MD and David Horne, MD
Below is the list of VA Medical Center sites with the site name and the PI:
- SAN ANTONIO: San Antonio VA Medical Center, University of Texas/San Antonio VA Hospital (Site #63), PI Marc Weiner, MD
- STELLENBOSCH: Stellenbosch University, Cape Town, South Africa, PI Anneke Hesseling, MD; administered via sub-contract under the Washington DC VA Medical Center
- WASHINGTON DC: Washington DC VA Medical Center, Washington, District of Columbia, coordinating center for the VA Affiliates Group (Site# 53), PI Debra Benator, MD
- MINNEAPOLIS: Minneapolis VA Medical Center, (Site# 60), PI Dimitri Drekonja; in collaboration with R. Bryan Rock PhD
- NEW YORK: VA New York Harbor Healthcare System (Site #64), in collaboration with New York City Bureau of Tuberculosis Control, PI Jana Preis
Current TBTC Studies
TBTC studies are large and complex and include TBTC protocol teams to ensure accuracy. TBTC has a long practice of including co-chairs from multiple institutions for studies, which further fortifies the consortium’s studies stability. As an example, TBTC study 31 had more than 25 investigators on the protocol team from more than 15 institutions. There will be continuity among some of the study co-chairs and members of the protocol team and among the CDC study officers for each active TBTC study (Studies 35 and 37). CDC has initiated startup activities with the new vendors (such as Institutional Review Board approvals, patient recruitment, drug distribution, and laboratory set-up) and they will transition into leadership roles within the Consortium. CDC will also conduct a review of gaps in expertise among CDC staff and currently funded sites, in order to determine whether there is additional scientific coverage necessary following the transition to the new Consortium. The new Consortium will be engaged in the active studies described below:
Study 35 is an investigation to prevent TB in children by establishing, for the first time, what dose of medication should be used. A major obstacle to dosing young children has been the lack of TB medicines specifically formulated for children, many of whom have difficulty swallowing tablets that were made for adults. Study 35 is making use of a new combined formulation of medication that can be dissolved in water and tastes like mango, making it easier for children to swallow.
Study 37 is evaluating shortening treatment for latent TB infection. The study compares patients taking six weeks of daily medication to the currently recommended three to four months of medication. As TB prevention medication may have dangerous side effects, such as hepatotoxicity, and must be taken daily, a shorter treatment will be enormously beneficial to patients. This study will inform improvements on adherence to therapy and greatly lessen the chances of progression to active disease.
CDC is confident that TBTC will continue to contribute to development of stronger approaches to treatment and prevention of TB over the next decade.
Philip LoBue, MD, FACP, FCCP
Division of Tuberculosis Elimination
National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention