TB/HIV Coinfection Working Group
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Emory University CFAR

Primary contacts

Henry M. Blumberg:            henry.m.blumberg@emory.edu
Carlos del Rio:            cdelrio@emory.edu

1.  HIV/TB Co-infection Projects:
Title:  Zambia-Emory Research Initiative in Tuberculosis and TB/HIV
Description:  Utility of a new generation of TB diagnostics (interferon-g release assays [IGRAs]) for the diagnosis of latent TB infection among HIV discordant couples.                                
PI:  Henry M. Blumberg, M.D. (henry.m.blumberg@emory.edu)
Co-PIs:  Carlos del Rio, Susan Allen, Naasha Talati

South Africa
Title:  Infant Immunization to reduce pneumonia in HIV+ women – Part Retrospective 1 & 2
Description: Burden and risk factors for pneumonia in HIV-infected adults, Soweto, South Africa:  a baseline assessment prior to an intervention with pneumococcal conjugate vaccine.
PI:  Keith Klugman (keith.klugman@emory.edu)
Co-PIs:  Werner Albrich, Shabir Madhi

Title:  The Burden of Pneumococcal Pneumonia in Adult South Africans
Description:  To detect a difference between standard microbiological tests and a combination of new diagnostic tests for S. pneumonia within hospitalized patients, powered to detect a 10% difference.
PI:  Keith Klugman (keith.klugman@emory.edu)
Co-PIs:  Werner Albrich, Shabir Madhi
[Note:  The primary focus of these studies is pneumonia but they involve TB and HIV as well.]

Republic of Georgia 
Title: TB, HIV, and TB/HIV research training (supported by NIH Fogarty International Center Global Infectious Diseases and AITRP grants)
Description:  “Emory-Georgia TB Research Training”
PI:  Henry M. Blumberg (henry.m.blumberg@emory.edu)

Title: TB, HIV, and TB/HIV research training (supported by NIH Fogarty International Center Global Infectious Diseases and AITRP grants)
Description: Emory AITRP 
PI: Carlos del Rio (cdelrio@emory.edu)

Title: Latent TB Infection among HIV-infected individuals
Description: Utility of new TB diagnostics. 
PI: Carlos del Rio (cdelrio@emory.edu)

Title:  Prevalence and Risk Factors for Extensively Drug Resistant TB (XDR-TB)
Description:  A Population Based Study in Georgia. 
PI:  Michael Leonard (mkleona@emory.edu)

Title:  Role of Mycobacterium tuberculosis protease in pathogenesis and host response
Description:  To study immune responses in human tuberculosis and HIV/TB co-infection.
PI: Jyothi Rengarajan (jrengar@emory.edu)

HIV/TB Co-infection Clinical Trials:
Trials in Development

Protocol Number: A5279
Title: Phase III Clinical Trial of Short-Course Rifapentine/Isoniazid for the Prevention of Active Tuberculosis in HIV-Infected Adults with Latent Tuberculosis Infection
Phase: III
Design: Randomized, Stratified, Open-label, Multicenter
Study Co-Chair: Susan Swindells, M.B.B.S. and Richard E. Chaisson, M.D.

Protocol Number: A5253
Title: Sensitivity and Specificity of Mycobacterium Tuberculosis Screening and Diagnostics in HIV-Infected Individuals
Phase: N/A
Design: Observational study
IND Number: Non-IND
Study Co-Chair: Srikanth Prasad Tripathy, M.D., M.B.B.S. and Susan Swindells, M.B.B.S.

Trials Open
Protocol Number: A5255
Title: FASTER AFB Identification, Speciation of Tuberculosis, and Evaluation of Drug Resistance in HIV-Infected Persons Initiating TB Therapy
Phase: N/A
Design: Observational study
Study Co-Chair: Cynthia (Cindy) Firnhaber, M.D. and Annie Luetkemeyer, M.D.

Protocol Number: A5221
Title: STRIDE A Strategy Study of Immediate Versus Deferred Initiation of Antiretroviral Therapy for HIV-Infected Persons Treated for Tuberculosis with CD4 <250 Cells/mm3
Phase: IV
Design: Randomized, Stratified, Open-label, Multicenter
Study Chair: Diane V. Havlir, M.D.

TB Research Not Specifically Involving HIV/TB Co-infection:
Republic of Georgia
Title:  Role of Hepatitis C Virus as a Risk Factor for Anti-tuberculosis Drug Induced Hepatotoxicity.
PI:  Henry M. Blumberg (henry.m.blumberg@emory.edu)

Title:  Impact of Vitamin D Supplementation on Host Immunity to M. tuberculosis and Response to Treatment: Building Translational Research Capacity in Nutrition and Infectious Diseases in the Republic of Georgia
PI: Thomas Ziegler (tzieg01@emory.edu)

Title: Impact of Vitamin D supplementation on LL-37 levels in plasma and cathelicidin/LL-37 mRNA and protein expression in skin among patients with tuberculosis
PI:  Henry M. Blumberg (henry.m.blumberg@emory.edu)

Title:  Tuberculosis Epidemiology Studies Consortium
Description:  (CDC-funded 16 multicenter site consortium involved in investigator initiated TB epidemiology and diagnostic studies).  Multiple ongoing projects 
Emory PI:  Henry M. Blumberg, M.D. (henry.m.blumberg@emory.edu)

Title: Tuberculosis Trials Consortium (TBTC).  CDC-funded multi-site consortium involved in TB clinical trials.  Multiple ongoing projects. 
Emory PI:  Susan Ray, M.D. (susan.ray@emory.edu)

Title:  Preventing the emergence of drug resistant tuberculosis
Description:  includes prevention of nosocomial transmission of tuberculosis, collaboration with public health, implementation science, utility of new diagnostics 
PI: Henry M. Blumberg (henry.m.blumberg@emory.edu)

Title:  Can Interferon-g Release Assays be used to Monitor Treatment Response in Latent Tuberculosis Infection? 
PI:  Naasha J. Talati (ntalati@emory.edu)

Title:  Tuberculosis Public Health Prevention/Medical Consultation. 
PI: Michael Leonard (mkleona@emory.edu)

TB Research not specifically involving HIV/TB co-infection (Clinical Trials)
Open Trials
Protocol Number: A5259 (TBTC Study)
Title: A Study of the Effectiveness and Tolerability of Weekly Rifapentine/Isoniazid for Three Months Versus Daily Isoniazid for Nine Months for the Treatment of Latent Tuberculosis Infection
Phase: III
Design: Randomized, Open-label, Multicenter
Study Chair: Timothy R. Sterling , M.D., M.P.H.

Protocol Number: A5274
Title: REMEMBER Reducing Early Mortality and Early Morbidity By Empiric Tuberculosis Treatment Regimens
Phase: IV
Design: Randomized, Comparative, Stratified, Open-label, Multicenter
Study Co-Chair: Mina Christine Hosseinipour, M.D. and Johnstone Kumwenda, M.D., M.B.B.S., MMED

2. Inter-CFAR Shared Resources:
Resource: Clinical Database and Linked Specimen Repository

Director:  Wendy Armstrong (wsarmst@emory.edu)