Testing New Strategies for Patients Hospitalised With HIV-associated Disseminated Tuberculosis
Status:
Not yet recruiting
Trial end date:
2024-12-31
Target enrollment:
Participant gender:
Summary
The New Strat-TB trial is a superiority Phase III randomised control clinical trial with a
2X2 factorial design. The main aim of the study is to assess the efficacy and safety of high
dose rifampicin and levofloxacin for 14 days in addition to standard TB therapy with or
without steroids among adults hospitalized with HIV-associated disseminated tuberculosis.
The investigators hypothesize that intensified treatment with increased rifampicin doses at
35 mg/kg plus levofloxacin will more rapidly reduce the mycobacterial load. The investigators
also hypothesize that steroids will have an immune-modulatory effect and dampen the
activation of the innate immune system. The investigators hypothesize that these two
strategies will lead to improved survival in patients hospitalized with HIV-associated
disseminated tuberculosis.