1,400
Participants
Start Date
December 31, 2008
Primary Completion Date
February 28, 2014
Study Completion Date
August 31, 2014
Prednisolone
Prednisolone and placebo will be supplied as 5 mg identical tablets and given at a dosage of 120 mg/day in the first week, followed by 90 mg/day in the second week, 60 mg/day in the third week, 30 mg/day in the fourth week, 15 mg/day in the fifth week, and 5 mg/day in the sixth week.
Mycobacterium w immunotherapy
Patients enrolled in the Mycobacterium w experimental arm will receive 5 doses of 0.1 ml of the vaccine intradermally (on enrolment, at 2 weeks, 4 weeks, 6 weeks, and 3 months). Patients in the control arm of the Mycobacterium w comparison will receive a similar regime of placebo injections of normal saline in identically-packaged vials.
Groote Schuur Hospital, Cape Town
Collaborators (1)
Population Health Research Institute
OTHER
University of Cape Town
OTHER