Mali 01: Pilot Study of CD4+ T Cell Immune Responses to Mycobacterium Tuberculosis. The protocol was closed to new enrollment on December 31st 2008. The last patient completed the study in December 2009. Data from the study have been presented at international meetings and manuscripts are in preparation. Mali 02: Establishment of Normal Parameters for Blood and Sputum with Samples Obtained From Volunteers in Bamako. Ongoing Mali 03: Correlation of the Precursor Frequency of CD4 + Effector Memory T cells with Induration measured in the Tuberculin Skin Test (TST). Enrolling. This protocol will be completed in FY12 at no additional cost with previously purchased reagents. Mali 04: A Cohort Observational Study to Assess the Virologic Response to Standard HIV Treatment in Bamako, Mali. Commenced December 2008. Enrolling. Completion of enrollment in December 2009. Study completed in FY11. Manuscripts are in preparation. Mali 05: Strategic Timing of Antiretroviral Therapy (START) Multi-centered, international protocol commenced enrollment in Mali in October 2009 to evaluate the question of the most appropriate time to initiate antiretroviral therapy in persons with HIV infection. The Mali site has been a top enrolling site. Mali 06: Oral Urea Breath Testing (UBT) for Diagnosis and Treatment Response in Pulmonary Tuberculosis. The UBT has been used to detect infection with H. pylori by testing individual breath samples. Researchers are interested in determining whether breath samples can also be used to detect the presence of M. tuberculosis in the lungs of subjects with tuberculosis, and to see if tuberculosis treatments are successful. This study has successfully completed an initial pilot enrollment which will lead to a main study with a goal for completion in FY12. Mali 07: Utility of Microscopic-Observation Drug-Susceptibility (MODS) test for diagnosis of MDR-TB and second-line antituberculous drug susceptibility. The purpose of this study is to test a new method for diagnosing TB, developed for rapid diagnosis of TB and simultaneous detection of resistance to TB medications in resource-limited settings. In FY11, all required scientific and ethic committee approvals have been secured. Completions of required assay validations are being completed. Patient enrollment is expected to begin in the fall of 2011.
