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Please use this identifier to cite or link to this item: http://hdl.handle.net/123456789/1652

Title: Immunoadjuvant prednisolone therapy for HIV-associated tuberculosis: a phase 2 clinical trial in Uganda.
Authors: Mayanja-Kizza, Harriet
Jones-Lopez, Edward
Okwera, Alphonse
Wallis, Robert S.
Ellner, Jerrold J.
Mugerwa, Roy D.
Whalen, Christopher C.
Keywords: HIV/AIDS
Copathogenesis
Tuberclosis (TB)
Antituberculous therapy
Clinical studies
Cytokines
CD4+ T cell counts
Mycobacterium tuberculosis
Kampala
Issue Date: 2-Feb-2005
Publisher: University of Chicago Press
Citation: Mayanja-Kizza, Jones-Lopez, D., Okwera, A., Wallis, R.S., Ellner, J.J., Mugerwa, R.D., Whalen, C.C. (2005). Immunoadjuvant prednisolone therapy for HIV-associated tuberculosis: a phase 2 clinical trial in Uganda. Journal of Infectious Diseases, 191
Abstract: Background. Human immunodeficiency virus (HIV)–infected patients with tuberculosis (TB) respond to effective antituberculous therapy, but their prognosis remains poor. Mounting evidence from clinical studies supports the concept of copathogenesis in which immune activation that is triggered by TB and mediated by cytokines stimulates viral replication and worsens HIV infection, especially when immune function is preserved. Methods. We performed a phase 2, randomized, double-blind, placebo-controlled clinical trial in Kampala, Uganda, to determine whether immunoadjuvant prednisolone therapy in HIV-infected patients with TB who have CD4+ T cell counts ≥200 cells/mL is safe and effective at increasing CD4+ T cell counts. Results. Short-term prednisolone therapy reduced levels of immune activation and tended to produce higher CD4+ T cell counts. Although prednisolone therapy was associated with a more rapid clearance of Mycobacterium tuberculosis from the sputum, it was also associated with a transient increase in HIV RNA levels, which receded when prednisolone therapy was discontinued. The intervention worsened underlying hypertension and caused fluid retention and hyperglycemia. Conclusion. The benefits of prednisolone therapy on immune activation and CD4+ T cell counts do not outweigh the risks of adverse events in HIV-infected patients with TB and preserved immune function.
URI: http://hdl.handle.net/123456789/1652
ISSN: 0022-1899
Appears in Collections:Research Articles (Health-Sciences)

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