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Mon. Jul 07 2008
     
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Tuberculosis Research Unit –Completed & Ongoing Clinical Studies

Study Title & Work Component

Sample Size
Performance Site
Status
       
Household Transmission of Tuberculosis [Epidemiology]
1,000
Uganda
Completed
Kawempe Community Health Study - Tuberculosis Transmission Study [Epidemiology]
1,500
Uganda
Ongoing
   
Pilot Studies (I-IX) to Assess Ex vivo Regulation of Host Cell-mediated and Humoral Immune Responses during Short Course Anti-TB Treatment of HIV-non-infected and HIV infected Adults [Immunology]
100
Uganda
Ongoing
Immunologic Correlates of Host Susceptibility to M. tuberculosis Infection and Progression to Active TB in Household Contacts of Patients with Sputum Smear Positive Tuberculosis [Immunology]
1,000
Uganda
Ongoing
Pilot Study to Assess Immunologic and Microbiologic Predictors of Response to Short Course Anti-TB Treatment in HIV-non-infected Adults with Initial Episodes of Smear Positive Pulmonary Tuberculosis [Immunology/Microbiology]
80
Brazil
Ongoing
Immunopathogenesis and Role of Apoptosis in Tuberculous Pleurisy [Immunology]
60
Uganda
Ongoing
Immune Response to BCG Vaccination in HIV-infected Newborns
260
South Africa
Ongoing
   
Pilot Studies of the Utility of New Surrogate Microbial Markers to Assess in vivo Antimicrobial Activity in HIV-infected and HIV-non-infected Adults with Pulmonary TB Receiving Standard Short Course Therapy [Microbiology]
79
Brazil, New York, Uganda
Completed
     
Phase I/II Study of the Safety and Microbiologic and Immunologic Activity of Heat-killed M. vaccae Immunotherapeutic Agent as an Adjunct to Standard Chemotherapy for the Initial Treatment of Pulmonary TB in HIV-non-infected Adults [Clinical Trials]
20
Uganda
Completed
An Open Label Multiple Doses Study of the Safety and the Early Bactericidal Activity of KRM-1648 in the Treatment of Newly Diagnosed Adults with Smear-Positive Tuberculosis [Clinical Trials]
60
Brazil
Completed
Phase II Randomized, Placebo-Controlled Trial of the Safety and Preliminary Evidence for Microbiologic and Immunologic Activity of Recombinant Human IL-2 (Proleukin) in HIV-non-infected Adults with Pulmonary TB [Clinical Trials]
110
Uganda
Completed
Phase III Study of Shortening the Duration of Standard Short Course Chemotherapy from 6 Months to 4 Months in HIV-non-infected Adults with Non-cavitary Tuberculosis Who Convert Their Sputum Cultures to Negative after 2 Months of Treatment [Clinical Trials]
758
Brazil, Philippines, Uganda
Ongoing
Phase I Study of the Early Bactericidal Qctivity of Linezolid and Moxifloxacin in HIV-non-infected Adults with Initial Episodes of Smear Positive Tuberculosis [Clinical Trials]
70
Brazil
Ongoing