Status:
WITHDRAWN
Paradoxical Tuberculosis Immune Reconstitution Inflammatory Syndrome (TB-IRIS) Treatment Trial
Lead Sponsor:
University of Minnesota
Collaborating Sponsors:
Pfizer
Minnesota Medical Foundation
Conditions:
Immune Reconstitution Inflammatory Syndrome
Immune Reconstitution Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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 paradoxica...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01442428
Start Date
January 1 2014
End Date
June 1 2016
Last Update
November 25 2013
Active Locations (3)
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1
Ramathibodi Hospital
Bangkok, Thailand
2
Chiang Mai University
Chiang Mai, Thailand
3
Bamrasnaradura Infectious Diseases Institute
Nonthaburi, Thailand