Grant: Operating Grant

Human immunodeficiency virus (HIV) infection puts people, especially the young, at risk of opportunistic infections, such as tuberculosis. In Africa, the HIV epidemic has resulted in an increase in the number of cases of tuberculosis affecting various parts of the body, including the membrane surrounding the heart (i.e., pericardium). Pericardial tuberculosis is a serious form of tuberculosis that results in the death or serious complications for 1 in 2 people affected despite the use of anti-tuberculosis medication. The addition of corticosteroids to the anti-tuberculosis medication could result in the reduction of the number of deaths, but this hypothesis remains to be confirmed in appropriately designed clinical trials. Vaccination with the Mycobacterium w injection may also reduce the damage caused by the tuberculosis infection of the heart. We propose to conduct a randomized clinical trial in people with pericardial tuberculosis treated with anti-tuberculosis drugs. Patients will be randomly allocated to receive either prednisolone or a matching placebo tablet, and Mycobacterium w injection or placebo injection. The number of people who die or who develop hardening of the pericardium with compression of the heart (called pericardial constriction) or who need emergency evacuation of the pericardial fluid from pericardial sac for severe compression (called tamponade) will be compared in each group. If these therapies are proven to be effective, they could potentially benefit several tens of thousands of patients every year.