Co-trimoxazole prophylaxis reduces mortality in HIV-infected adults with TB.The aim of this study was to assess the impact of prophylactic oral cotrimoxazole in reducing mortality in HIV-positive Zambian adults being treated for pulmonary tuberculosis pulmonary tuberculosis
Tuberculosis of the lungs.
pulmonary tuberculosis Infectious disease Infection by Mycobacterium tuberculosis , using a double-blind placebo-controlled randomised Adj. 1. randomised - set up or distributed in a deliberately random way
irregular - contrary to rule or accepted order or general practice; "irregular hiring practices" clinical trial.
Two groups of antiretroviral treatment-naive adults with HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. infection were enrolled: patients newly diagnosed as having tuberculosis and receiving tuberculosis treatment either for the first time or for retreatment after relapse; and previously treated patients not receiving treatment. The intervention was oral cotrimoxazole or matching placebo daily.
A total of 1 003 patients were randomised: 835 (416 co-trimoxazole, 419 placebo) were receiving treatment for tuberculosis, 762 (376 co-trimoxazole, 386 placebo) of them newly diagnosed, previously untreated patients and 73 (40 co-trimoxazole, 33 placebo) receiving a retreatment regimen; 168 (84 co-trimoxazole, 84 placebo) were not on treatment but had received treatment in the past. Of 835 participants receiving tuberculosis treatment, follow-up information was available for 757, with a total of 1 012.6 person years of follow-up. A total of 310 (147 cotrimoxazole, 163 placebo) participants died, corresponding to death rates of 27.3 and 34.4 per 100 person years. In the Cox regression analysis In statistics, a mathematical method of modeling the relationships among three or more variables. It is used to predict the value of one variable given the values of the others. For example, a model might estimate sales based on age and gender. , the hazard ratio for death (co-trimoxazole:placebo) was 0.79 (95% confidence interval confidence interval,
n a statistical device used to determine the range within which an acceptable datum would fall. Confidence intervals are usually expressed in percentages, typically 95% or 99%. 0.63 - 0.99). The effect of co-trimoxazole waned with time, possibly owing to falling adherence levels; in a per protocol analysis based on patients who spent at least 90% of their time at risk supplied with the study drug, the hazard ratio was 0.65 (0.45 - 0.93).
The conclusions were that prophylaxis with co-trimoxazole reduces mortality in HIV-infected adults with pulmonary tuberculosis. Co-trimoxazole was generally safe and well tolerated.
Nunn AJ, et al. BMJ BMJ n abbr (= British Medical Journal) → vom BMA herausgegebene Zeitschrift 2008; 337: a257.