Paradoxical Tuberculosis Immune Reconstitution Inflammatory Syndrome (TB-IRIS) Treatment Trial

Launched by UNIVERSITY OF MINNESOTA · Sep 27, 2011

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Eligibility criteria

• Inclusion Criteria:
• • HIV-1 infection documented by any locally licensed ELISA or rapid HIV test kit.
• • Age \>18 years
• • Paradoxical TB-IRIS diagnosed by case definition (see section 5.2)
• • Ability and willingness of the participant or legal guardian/representative to give informed consent. Receiving appropriate ART and anti-TB therapy, as judged by the site investigator
• Exclusion Criteria:
• • Inability to take oral medication;
• • Receiving chemotherapy, immunosuppressant, corticosteroid, NSAID, or statin medications; (ASA is acceptable)
• • Cannot or unlikely to attend regular clinic visits;
• • Known allergy to NSAIDs, statins or corticosteroids;
• • Liver transaminase \> 2 times the upper limit of normal within 60 days of enrollment;
• • History of myositis/myopathy;
• • High Investigator Suspicion of anti-TB treatment failure due to TB-resistance or medication non-adherence;
• • Receiving ongoing azole anti-fungal for treatment or secondary prophylaxis of cryptococcosis, histoplasmosis or penicilliosis;
• • Serious co-morbidities, co-infections, or laboratory values who should not receive NSAIDs, steroid or statins, as judged by the site investigator;
• • Minimal IRIS reaction which is unlikely to require treatment, as judged by the site investigator;
• • Pregnancy (a negative urine pregnancy test at screening is required for women of childbearing potential) or breast feeding;
• • Receiving a HIV treatment regimen containing a protease inhibitor at study entry.
• • Exclusion for Randomization A Only
• * Life threatening TB-IRIS, as defined by:
• • Acute respiratory failure; PaO2 \< 60 on room air or;
• • Altered mental status or;
• • New focal neurological deficit or;
• • Compression of the vital organs.
• • Persons with uncontrolled diabetes mellitus;
• • Impair kidney function, glomerular filtration rate \<60 ml/min; within 72 hours of consent
• • Uncontrolled congestive heart failure
• • History of bleeding disorder;
• • Platelet count \<100,000/µL;
• • History of significant gastrointestinal bleeding or ulceration;
• • Prior adjunctive corticosteroid therapy for this TB episode for \> 48 hr;
• • Pregnancy