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Your journey
1What's a trial
4Get in touch
More info
You can access this
clinical trial
if you have
Immune Reconstitution Inflammatory Syndrome, Immune Reconstitution Syndrome, Tuberculosis or HIV-infection/Aids
and you are
over 18
years old
This is an advanced phase trial assessing
the effectiveness of the new treatment before being released on the market.
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The purpose

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.

Provided treatments

  • Drug: Dexamethasone
  • Drug: Atorvastatin
  • Drug: Naproxen
  • Drug: Placebo

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT01442428. The sponsor of the trial is University of Minnesota and it is looking for 0 volunteers for the current phase.
Official trial title:
Randomized Controlled Trial for Corticosteroids Versus NSAIDs With or Without Adjunctive Atorvastatin for the Treatment for Paradoxical Tuberculosis Immune Reconstitution Inflammatory Syndrome