predART

Preventing tuberculosis-associated immune reconstitution inflammatory syndrome in high-risk patients:
A randomized placebo-controlled trial of prednisone (Pred-ART trial)

Summary

Tuberculosis (TB) is the most common opportunistic infection amongst HIV-infected patients starting antiretroviral therapy (ART) in developing countries and thus the most frequent form of immune reconstitution inflammatory syndrome (IRIS). Paradoxical TB-IRIS occurs in 8- 43% of patients starting ART while on TB treatment and results in morbidity, hospitalisation, consumes health care resources and TB-IRIS may be fatal. We have previously demonstrated in a clinical trial that prednisone reduces morbidity when used for treatment of paradoxical TB-IRIS. This trial is a double-blind placebo-controlled trial of prophylactic prednisone (40mg/day for 2 weeks followed by 20mg/day for 2 weeks, started on the same day as ART) in patients with TB who are identified as being at high risk for paradoxical TB-IRIS (starting ART within 30 days of initiating TB treatment and CD4 < 100/μL). The trial will enroll 240 participants, randomised 1:1 (prednisone:placebo). The primary endpoint is development of paradoxical TB-IRIS, defined using international consensus case definitions. Secondary endpoints include time to IRIS event, severity of IRIS, quality of life assessment, mortality and corticosteroids adverse events. The trial is powered to determine a reduction in TB-IRIS events.

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Funding



Research Information

Research institution: Clinical Infectious Diseases Research Initiative (CIDRI), Institute of Infectious Diseases and Molecular Medicine (IDM), University of Cape Town (UCT), South Africa
Study start date: August 2013
Study completion date: February 2015
Estimated enrollment: 240 participants
Research Site: Site B Khayelitsha, South Africa
Status: Recruiting

Ethics and Regulatory :

Ethics Approval : Approved
Ethics committee(s): UCT Ethics Committee,
Antwerp Ethics Committee
Other approval(s): MCC South Africa,
Provincial Approval of Western Cape, South Africa
Registrations(s): ClinicalTrials.gov,
Pan African Clinical Trials Registry

Research Team

Prof. Graeme Meintjes (Principle Investigator)
Dr. Liz Blumenthal (Senior Medial Officers)
Dr. Charlotte Schutz (Senior Medial Officers)
Amy Nair (Study coordinator)
Yolisa Sigila (Senior Research Nurse)
Monica Magwayi (Study Counsellor)
Cari Stek (Sub-Investigator)
Rene Goliath (Project Coordinator)
Loraine Swanepoel (Pharmacist)
Nash Omar-Davies (Radiographer)
Dr. Friedrich Thienemann (Co-Investigator)
Amanda Jackson (Data Systems Manager)
Antoneta Mashinyira (Data Manager)
Nomvula Makade (Date Clerk)
Robyn Louw (Date Clerk)
Brian Basini (Driver)
Buhle Benkosi (Driver)