BACKGROUND: Active tuberculosis may accelerate progression of human immunodeficiency virus (HIV) infection by promoting viral replication in activated lymphocytes. Glucocorticoids are used in pleural tuberculosis to reduce inflammation-induced pathology, and their use also might reduce progression of HIV by suppressing immune activation. We examined the effect that prednisolone has on survival in HIV-1-associated pleural tuberculosis. METHODS: We conducted a randomized, double-blind, placebo-controlled trial of prednisolone as an adjunct to tuberculosis treatment, in adults with HIV-1-associated pleural tuberculosis. The primary outcome was death. Analysis was by intention to treat. RESULTS: Of 197 participants, 99 were assigned to theprednisolone group and 98 to the placebo group. The mortality rate was 21 deaths/100 person-years (pyr) in the prednisolone group and 25 deaths/100 pyr in the placebo group (age-, sex-, and initial CD4+ T cell count-adjusted mortality rate ratio, 0.99 [95% confidence interval, 0.62-1.56] [P =.95]). Resolution of tuberculosis was faster in the prednisolone group, but recurrence rates were slightly (though not significantly) higher, and use of prednisolone was associated with a significantly higher incidence of Kaposi sarcoma (4.2 cases/100 pyr, compared with 0 cases/100 pyr [P =.02]). CONCLUSIONS: In view of the lack of survival benefit and the increased risk of Kaposi sarcoma, the use of prednisolone in HIV-associated tuberculous pleurisy is not recommended.
RCT Entities:
BACKGROUND: Active tuberculosis may accelerate progression of human immunodeficiency virus (HIV) infection by promoting viral replication in activated lymphocytes. Glucocorticoids are used in pleural tuberculosis to reduce inflammation-induced pathology, and their use also might reduce progression of HIV by suppressing immune activation. We examined the effect that prednisolone has on survival in HIV-1-associated pleural tuberculosis. METHODS: We conducted a randomized, double-blind, placebo-controlled trial of prednisolone as an adjunct to tuberculosis treatment, in adults with HIV-1-associated pleural tuberculosis. The primary outcome was death. Analysis was by intention to treat. RESULTS: Of 197 participants, 99 were assigned to the prednisolone group and 98 to the placebo group. The mortality rate was 21 deaths/100 person-years (pyr) in the prednisolone group and 25 deaths/100 pyr in the placebo group (age-, sex-, and initial CD4+ T cell count-adjusted mortality rate ratio, 0.99 [95% confidence interval, 0.62-1.56] [P =.95]). Resolution of tuberculosis was faster in the prednisolone group, but recurrence rates were slightly (though not significantly) higher, and use of prednisolone was associated with a significantly higher incidence of Kaposi sarcoma (4.2 cases/100 pyr, compared with 0 cases/100 pyr [P =.02]). CONCLUSIONS: In view of the lack of survival benefit and the increased risk of Kaposi sarcoma, the use of prednisolone in HIV-associated tuberculous pleurisy is not recommended.
Authors: Harriet Mayanja-Kizza; Edward Jones-Lopez; Alphonse Okwera; Robert S Wallis; Jerrold J Ellner; Roy D Mugerwa; Christopher C Whalen Journal: J Infect Dis Date: 2005-02-08 Impact factor: 5.226
Authors: Bongani M Mayosi; Mpiko Ntsekhe; Jackie Bosch; Shaheen Pandie; Hyejung Jung; Freedom Gumedze; Janice Pogue; Lehana Thabane; Marek Smieja; Veronica Francis; Laura Joldersma; Kandithalal M Thomas; Baby Thomas; Abolade A Awotedu; Nombulelo P Magula; Datshana P Naidoo; Albertino Damasceno; Alfred Chitsa Banda; Basil Brown; Pravin Manga; Bruce Kirenga; Charles Mondo; Phindile Mntla; Jacob M Tsitsi; Ferande Peters; Mohammed R Essop; James B W Russell; James Hakim; Jonathan Matenga; Ayub F Barasa; Mahmoud U Sani; Taiwo Olunuga; Okechukwu Ogah; Victor Ansa; Akinyemi Aje; Solomon Danbauchi; Dike Ojji; Salim Yusuf Journal: N Engl J Med Date: 2014-09-01 Impact factor: 91.245