A randomised controlled trial of prednisone versus placebo in the management of human immunodeficiency virus (HIV)-infected patients presenting with mild to moderate Tuberculosis-associated Immune Reconstitution Inflammatory Syndrome after commencing Highly Active Antiretroviral Therapy

Completed

• Conditions: HIV and Tuberculosis-associated Immune Reconstitution Inflammatory Syndrome; Infections and Infestations; Human immunodeficiency virus (HIV)

• Registration Number: ISRCTN21322548
• Lead Sponsor: niversity of Cape Town - Research Ethics Committee, Faculty of Health Sciences (South Africa)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08-17
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

A. Age 18 years and over

B. Informed consent (written)

C. Prior to the introduction of HAART the following criteria must be met for the diagnosis of TB-IRIS to be considered:
1. The patient has HIV infection
2. The patient should be antiretroviral-naïve (excluding receipt of antiretroviral treatment within mother to child transmission programmes ? Nevirapine single-dose with or without Zidovudine in the third trimester)
3. The patient has microbiologic, histologic or very strong clinical evidence of tuberculosis
4. There has been a documented improvement in symptoms, Karnofsky score and/or weight, resolution of fever and clinical and radiological stabilization during the intensive phase of multidrug TB therapy
5. That adherence with anti-TB treatment is >80%
6. That the infecting strain of M. tuberculosis is sensitive to rifampicin, if this result is available

D. Consider TB-IRIS if, within 3 months of the introduction of multi-drug HAART
1. Adherence with HAART is documented and the patient was on anti-tuberculous therapy when HAART commenced
2. There are new or recurrent constitutional symptoms PLUS one or more of:
i. New or expanding lymph nodes (>20 mm or >50% in volume)
ii. New or expanding tuberculous cold abscesses (e.g. paraspinal)
iii. New or expanding pulmonary infiltrates (radiographically confirmed)
iv. New or enlarging serous effusions (pericardial, pleural or ascitic)
Patients presenting with other manifestations of TB-IRIS (e.g. central nervous system [CNS] tuberculoma) will not be included in this study.

Exclusion Criteria

1. Previous systemic steroid therapy as part of the management of tuberculosis
2. Pregnancy
3. Uncontrolled Diabetes Mellitus
4. Adrenal failure
5. Severe TB-IRIS (these cases will receive open label corticosteroids) manifested by:
a. Respiratory failure (pO2 <8 kPa)
b. Altered level of consciousness or new focal neurological signs
c. Compression of vital structures (e.g. bronchostenosis)
6. Kaposi?s sarcoma

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Combined hospitalisation and procedures endpoint (cumulative duration of hospitalisation in days + outpatient therapeutic procedures counted as one day)