Transformative Science in TB Research Group
Explore the members, research sites, and scientific agenda of the ACTG TB Transformative Science Group, working towards advancements in TB treatment and prevention. Meet the dedicated professionals driving innovation in TB research worldwide.
Download Presentation
Please find below an Image/Link to download the presentation.
The content on the website is provided AS IS for your information and personal use only. It may not be sold, licensed, or shared on other websites without obtaining consent from the author. If you encounter any issues during the download, it is possible that the publisher has removed the file from their server.
You are allowed to download the files provided on this website for personal or commercial use, subject to the condition that they are used lawfully. All files are the property of their respective owners.
The content on the website is provided AS IS for your information and personal use only. It may not be sold, licensed, or shared on other websites without obtaining consent from the author.
E N D
Presentation Transcript
ACTG TB Transformative Science Group Richard E. Chaisson, Chair Diane V. Havlir, Vice-Chair Gavin J. Churchyard, Vice-Chair Sue Swindells, Protocol Development Facilitator
ACTG Clinical Research Sites UNAIDS 2001
TB TSG Membership Cecilia Kanyama, Malawi CRS Serena Koenig, Harvard University Annie Luetkemeyer, University of California, San Francisco Gary Maartens, University of Cape Town Vidya Mave, BJ Medical College CRS Alberto Mendoza, Barranco CRS John Metcalfe, University of California, San Francisco Flavia Miiro, JCRC/Kampala CRS Sachiko Miyahara, SDAC Payam Nahid, University of California, San Francisco McNeil Ngongondo, Malawi CRS Eric Nuermberger, Johns Hopkins University Elisha Okeyo, KEMRI/CDC CRS Parita Rathod, Network Coordinating Center Ian Sanne, Wits HIV CRS Tejaswi Sevekari, BJ Medical College CRS Kim Scarsi, University of Nebraska Medical Center Sarita Shah, Center for Disease Control Susan Swindells, University of Nebraska Medical Center Robert Wallis, The Aurum Institute Richard Chaisson, Johns Hopkins University, Chair Gavin Churchyard, The Aurum Institute, Co-Vice Chair Diane Havlir, University of California, San Francisco, Co-Vice Chair David Alland, University of Medicine and Dentistry of New Jersey Janet Andersen, SDAC Constance Benson, University of California, San Diego Henry Blumberg, Emory University Francesca Conradie, University of the Witwatersrand Helen Joseph CRS Andreas Diacon, Stellenbosch University Kelly Dooley, Johns Hopkins University Jennifer Furin, Case Western Reserve University Devasena Gnanashanmugam, DAIDS Amita Gupta, Johns Hopkins University Richard Hafner, DAIDS Mark Harrington, Treatment Action Group Elizabeth Hawkins, Network Coordinating Center Robert Horsburgh, Boston University Lynne Jones, Data Management Center
The TB TSG Scientific Agenda 1.0 To identify regimens to shortenDrug-Susceptible TB treatment to 3 months in patients with and without HIV TB TREATMENT SHORTENING 2.0 To identify regimens for MDR TB treatment in <6 months in patients with and without HIV MDR-TB TREATMENT 3.0 To identify regimens to treat latent TB in 1 month and MDR-TB infection in 6 months; to improve latent TB therapy in HIV-infected individuals PREVENTIVE THERAPY
The TB TSG Scientific Agenda 4.0 To optimize the treatment of TB/HIV co-infection To evaluate and minimize drug-drug interactions TB/HIV CO-TREATMENT 5.0 Pharmacology Biomarkers Laboratory monitoring and diagnostics Host-directed therapies TRANSFORMATIVE SCIENCES
ACTG TB Treatment Studies Study Description Status Accrual/Target A5307 Essentiality of INH in the initial phase of TB therapy, a comparison with moxifloxacin Phase 1 EBA trial Completed 63 A5344/ STAND Phase 3 trial of Pa824/Moxi/PZA to shorten TB therapy to 4 months (with TB Alliance) On hold /400 A5349/ TBTC 31 Phase 3 trial of rifapentine + moxifloxacin to shorten TB therapy to 4 months Enrolling 118/1250 A5290 LPV/r + DTG in patients on TB therapy Closed to accrual 71/60 A5362 A Phase IIc Trial of Clofazimine for Treatment Shortening in DS TB In development /696
MDR TB Protocol Status Study Description Status Accrual/Target A5312 Early bactericidal activity of high-dose INH in patients with MDR TB and inha mutations Enrolling A5343 PK safety study of bedaquiline and delamanid in patients with MDR TB in South Africa Enrolling 3/84 A5356 Linezolid dose-finding ranging study with delamanid and an optimized background regimen without injectables In development /240
TB preventive therapy Studies Study Description Status Accrual/Target A5279 Daily Rifapentine/INH for 1 month vs INH for 9 months to prevent TB in HIV+ patients In follow up till 11/2017 Enrolled 3000 participants as of 11/2014 Phoenix A5300/ P2003 Phase 3 trial of delamanid vs INH for high- risk contacts of M/XDR TB patients (with IMPAACT) Pilot study completed, main study in development 308 IC/1018 HHC enrolled in 6 mos Main study: /1726 IC /3452 HHC /3132 A5365 Cycled Ultra-Short Course Preventative INH/RPT in HIV in Medium to High TB- Endemic Areas In development
TB Transformative Sciences Studies Study Description Status Accrual/Target A5302 BioBank for Surrogate Marker Research for TB (B-SMART) With TB Alliance and TBTC Enrolling at limited sites /300 A5338 Pharmacokinetic Interactions among DMPA, RIF, and EFV in Women co- infected with HIV and TB (PRIDE-HT) Enrolling 29/46 A5289 Adaptive phase II safety and PK of sutezolid with rifampin or rifabutin in drug- susceptible TB In development /182
TB TSG Progress Report TB TSG is pursuing an ambitious portfolio of TB trials: HIV/TB co-management (A5290, A5338) Shortening TB treatment (A5307, A5344, TBTC 31/A5349, PR698, A5289) MDR TB (A5343, A5356, A5312) Latent TB infection (A5279, PR726) Latent MDR TB infection (A5300/I2003 PHOENIx) Partnerships are essential for conducting TB clinical trials: TBTC Study 31 TB Alliance STAND TBTC and TB Alliance Biomarkers IMPAACT Phoenix Pharma (Sanofi, Otsuka, Janssen) multiple studies
