Reducing Early Mortality and Early Morbidity by Empiric Tuberculosis Treatment Regimens
Sponsors: US National Institute of Allergy and Infectious Diseases (NIAID)
Protocol Summary: A5274 is a randomized, open-label, phase IV strategy trial, where participants from resource-limited settings (RLS) who present with advanced HIV disease and no probable or confirmed tuberculosis (TB), and who are initiating antiretroviral treatment (ART) will be randomized into one of two strategy arms: immediate, empiric TB treatment (public health approach) or local standard of care TB treatment (individualized approach). The primary endpoint is survival status in the two arms 24 weeks after randomization. AIDS progression, virologic and CD4+ cell response, HIV and TB drug resistance, safety and tolerability of, and adherence to HIV and TB drugs will be evaluated, as will the cost-effectiveness of the two strategies.
Years: 2013 – 2016
Investigator: James Hakim, MBChB, FRCP
Location: Parirenyatwa CRS