Randomized Controlled Trial for Corticosteroids Versus NSAIDs With or Without Adjunctive Atorvastatin for the Treatment for Paradoxical Tuberculosis Immune Reconstitution Inflammatory Syndrome
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, GFR <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