Clinical Trial: Paradoxical Tuberculosis Immune Reconstitution Inflammatory Syndrome (TB-IRIS) Treatment Trial
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
Official Title: Randomized Controlled Trial for Corticosteroids Versus NSAIDs With or Without Adjunctive Atorvastatin for the Treatment for Paradoxical Tuberculosis Immune Reconstitution Inflamm
Brief Summary: 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.
Detailed Summary:
Sponsor: University of Minnesota - Clinical and Translational Science Institute
Current Primary Outcome:
- Change in Clinical Symptom Score at Day 7, as measured by the 10-point visual analog scale to quantify symptom severity. [ Time Frame: Day 7 ]
- Change in serum C-reactive protein at Day 7 [ Time Frame: Day 7 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Days of hospitalization combined with outpatient therapeutic procedures [ Time Frame: 56 days ]
- Study medicine discontinuation [ Time Frame: 28 days ](e.g. switching to open-label medication)
- Karnofsky Performance Status Scale at day 7 and 28; [ Time Frame: Day 7 and Day 28 ]
- Incidence of Adverse Events [ Time Frame: 56 days ]DAIDS Grading Scale 3-5 events
- Radiologic improvement at 2 weeks; [ Time Frame: 14 days ]
- Mortality [ Time Frame: 56 days ]
- CD4 count change [ Time Frame: 28 days ]
- Recurrence of IRIS manifestations within the 8 week study period [ Time Frame: 56 days ]
- ART or TB therapy discontinuation [ Time Frame: 56 days ]
- Incidence of sputum acid fast bacilli (AFB) smear positivity at day 28 [ Time Frame: Day 28 ]
Original Secondary Outcome: Same as current
Information By: University of Minnesota - Clinical and Translational Science Institute
Dates:
Date Received: August 30, 2011
Date Started: January 2014
Date Completion: June 2016
Last Updated: November 20, 2013
Last Verified: November 2013