Preventing TB-IRIS in High-risk Patients: a Randomized Placebo-controlled Trial of Prednisone
Status:
Completed
Trial end date:
2017-04-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
University of Cape Town
Collaborators:
Department of Science and Technology, South Africa European and Developing Countries Clinical Trials Partnership (EDCTP) Imperial College London Institute of Tropical Medicine, Belgium