Testing New Strategies for Patients Hospitalised With HIV-associated Disseminated Tuberculosis

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.

NCT Number	NCT04951986
Lead Sponsor	University of Cape Town
Conditions	Disseminated Tuberculosis, HIV
Enrollment	732 participants
Start Date	2021-08-11
Primary Completion	2025-12-15 (estimated)
Study Completion	2026-03 (estimated)
Updated on ClinicalTrials.gov	2026-01-06