Tuberculosis is the most common opportunistic infection (OI) in HIV-infected persons
worldwide, including in South East Asia. Significant numbers of patients experience
tuberculosis-related paradoxical immune reconstitution inflammatory syndrome (TB-IRIS) after
ART initiation, yet the optimal treatment of TB-IRIS is unknown. A recent
randomized-controlled trial showed the benefit of prednisone over placebo in reduction of
days of hospitalization and invasive procedures. The investigators hypothesize that
nonsteroidal anti-inflammatory drugs (NSAIDs) are as effective as corticosteroids for
treatment of non-life threatening TB-IRIS in HIV-infected patients and hypothesize that
adjunctive treatment with 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase
inhibitors (Statins) may improve the outcomes. This is a randomized controlled trial with a
2x2 factorial design to test the relative benefit of corticosteroids, NSAIDS, and Statins for
the symptomatic and immunologic control of TB-IRIS.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
University of Minnesota University of Minnesota - Clinical and Translational Science Institute