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

> **NCT01442428** · PHASE2,PHASE3 · WITHDRAWN · sponsor: **University of Minnesota**

## Conditions studied

- Immune Reconstitution Inflammatory Syndrome
- Immune Reconstitution Syndrome
- Tuberculosis
- HIV-infection/Aids

## Interventions

- **DRUG:** Dexamethasone
- **DRUG:** Atorvastatin
- **DRUG:** Naproxen
- **DRUG:** Placebo

## Key facts

- **NCT ID:** NCT01442428
- **Lead sponsor:** University of Minnesota
- **Sponsor class:** OTHER
- **Phase:** PHASE2,PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** WITHDRAWN
- **Start date:** 2014-01
- **Primary completion:** 2016-03
- **Final completion:** 2016-06
- **Target enrollment:** 0 (ACTUAL)
- **Why stopped:** 2011 Thailand flooding led to loss of GMP pharmacy, project delays, and further regulatory challenges.
- **Last updated:** 2013-11-25

## Collaborators

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- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01442428

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01442428, "Paradoxical Tuberculosis Immune Reconstitution Inflammatory Syndrome (TB-IRIS) Treatment Trial". Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/clinical/NCT01442428. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*
