Paradoxical Tuberculosis Immune Reconstitution Inflammatory Syndrome (TB-IRIS) Treatment Trial
NCT01442428
ABOUT THIS STUDY
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Adult Trials: 18+ Years
- 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
- 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
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| Descriptive Information | ||||||||||
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| Brief Title ICMJE | Paradoxical Tuberculosis Immune Reconstitution Inflammatory Syndrome (TB-IRIS) Treatment Trial | |||||||||
| Official Title ICMJE | Randomized Controlled Trial for Corticosteroids Versus NSAIDs With or Without Adjunctive Atorvastatin for the Treatment for Paradoxical Tuberculosis Immune Reconstitution Inflammatory Syndrome | |||||||||
| 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 Description | Not Provided | |||||||||
| Study Type ICMJE | Interventional | |||||||||
| Study Phase ICMJE | Phase 2 Phase 3 | |||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Factorial Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | |||||||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | |||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||||||||
| Recruitment Information | ||||||||||
| Recruitment Status ICMJE | Withdrawn | |||||||||
| Actual Enrollment ICMJE | 0 | |||||||||
| Original Estimated Enrollment ICMJE | 100 | |||||||||
| Estimated Study Completion Date ICMJE | June 2016 | |||||||||
| Estimated Primary Completion Date | March 2016 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Exclusion for Randomization A Only
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||||||||
| Accepts Healthy Volunteers ICMJE | No | |||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||
| Listed Location Countries ICMJE | Thailand | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number ICMJE | NCT01442428 | |||||||||
| Other Study ID Numbers ICMJE | WS967180 | |||||||||
| Has Data Monitoring Committee | Yes | |||||||||
| U.S. FDA-regulated Product | Not Provided | |||||||||
| IPD Sharing Statement ICMJE | Not Provided | |||||||||
| Responsible Party | University of Minnesota | |||||||||
| Study Sponsor ICMJE | University of Minnesota | |||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| PRS Account | University of Minnesota | |||||||||
| Verification Date | November 2013 | |||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||||||||