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


Phase 2/Phase 3
18 Years
N/A
Not Enrolling
Both
Immune Reconstitution Inflammatory Syndrome, Immune Reconstitution Syndrome, Tuberculosis, HIV-infection/Aids

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Trial Information

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/┬ÁL;

- History of significant gastrointestinal bleeding or ulceration;

- Prior adjunctive corticosteroid therapy for this TB episode for > 48 hr;

- Pregnancy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Change in Clinical Symptom Score at Day 7, as measured by the 10-point visual analog scale to quantify symptom severity.

Outcome Time Frame:

Day 7

Safety Issue:

No

Principal Investigator

Sasisopin Kiertiburanakul, MD, MHS

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mahidol University

Authority:

Thailand: Ethical Committee

Study ID:

WS967180

NCT ID:

NCT01442428

Start Date:

July 2013

Completion Date:

June 2015

Related Keywords:

  • Immune Reconstitution Inflammatory Syndrome
  • Immune Reconstitution Syndrome
  • Tuberculosis
  • HIV-infection/Aids
  • TB
  • AIDS
  • HIV
  • IRIS
  • immune reconstitution inflammatory syndrome
  • anti-inflammatory
  • treatment
  • Acquired Immunodeficiency Syndrome
  • HIV Infections
  • Tuberculosis
  • Immune Reconstitution Inflammatory Syndrome

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